Gingivitis, Plaque
Conditions
Keywords
Reducing plaque, Reducing gingivitis, safety, proof of concept, antiplaque chewing gum
Brief summary
This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.
Detailed description
This study is a Phase 1/2a placebo-controlled, double-blind, randomized, dose-escalation study to evaluate the safety and proof of concept of Antiplaque Chewing Gum. This is a 2-part trial with 9 dosing cohorts in Phase 1 and 7 dosing cohorts in Phase 2a. For both phases, the oral soft (OST) and oral hard tissues (OHT) will be examined. Changes from baseline, such as soft tissue erythema, ulceration and sloughing, will be noted and assessments will be made by the principal investigator as to whether they might be attributable to the antiplaque chewing gum. In the Phase 2a portion of the study, the efficacy of the antiplaque chewing gum in reducing existing supragingival plaque and gingivitis will also be assessed. Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index (PI, Turesky et al-1970) and gingivitis will be assessed using both the Modified Gingival Index (MGI, Lobene et al-1986) and the percent of bleeding sites on gentle probing (BOP) using the methods described in Ainamo and Bay-1975.
Interventions
DRUG2 mg KSL-W
DRUG4 mg KSL-W
DRUG6 mg KSL-W
DRUG10 mg KSL-W
DRUG20 mg KSL-W
DRUG30 mg KSL-W
DRUG50 mg KSL-W
DRUG75 mg KSL-W
DRUG100 mg KSL-W
OTHERPlacebo
Cetylpyridinium chloride (CPC) as an additive, isomalt as a bulk sweetener, peppermint powder for flavoring, sucralose as an intense sweetener, colloidal silicon dioxide is a flow enhancer, magnesium stearate as a process aid, and the proprietary gum base formulation.
Sponsors
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following criteria to be included in the Phase 1 portion of the study: * Males and females between 18 and 64 years of age * A negative urine pregnancy test and willingness to use a reliable form of contraception for the duration of the study (females of childbearing potential only), with reliable contraception defined as: Abstinence Oral contraceptive, either estrogen progesterone combined, or progesterone alone Injectable progesterone Implants of levonorgestrel Estrogenic vaginal ring Percutaneous contraceptive patches Intrauterine device or intrauterine system Double barrier method \[condom or occlusive cap (diaphragm or cervical vault caps) plus spermicidal agent (foam, gel, film, cream, suppository)\] Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject * Good health, as determined by pertinent medical history, physical examination, vital signs, and clinical safety laboratory evaluations * A minimum of 16 natural teeth with 2 scorable surfaces (facial and lingual) per tooth Sufficient number of opposing posterior teeth to chew on both sides of the mouth as determined by the examining dentist Teeth that have gross caries, full crowns or extensive restorations on facial and/or lingual surfaces, orthodontic bands, and third molars are not included in the tooth count * Ability to comprehend and a willingness to sign an informed consent, which includes the Authorization for the Release of Health Information document * Willingness to comply with all study procedures Phase 2a Inclusion Criteria Subjects must meet all the criteria for the phase 1 portion of the study, and in addition must: * Have mild to moderate gingivitis and plaque MGI of 1.8 or greater (Ainamo and Bay-1975) PI of 1.95 or greater (Turesky et al-1970) * Willing to forgo any optional dental procedures during the study period, such as dental prophylaxis or teeth whitening
Exclusion criteria
Subjects meeting any of the following criteria will be excluded from the study: * Acute or chronic medical conditions, organ system disease, or medications that, in the principal investigator's opinion, would impair the subject's ability to participate * TMD * Self-reported use of tobacco products * Use of anticoagulant medications (eg clopidogrel) * Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumor of the oral cavity * Orthodontic appliances or removable partial dentures that will compromise the ability of the potential subject to participate in the study * Periodontitis as indicated periodontal pockets greater than 4 millimeters on more than one site * Receipt of any investigational drug/test product within 30 days prior to study entry * Receipt of antibiotics within 30 days prior to study entry * Need for antibiotic prophylaxis prior to invasive dental procedures * Receipt of daily anti-inflammatory therapy \[eg nonsteroidal anti-inflammatory drugs (NSAID), tumor necrosis factor (TNF) alpha blockers\] within 30 days prior to study entry * Receipt of prescription antibacterial oral products (eg products containing chlorhexidine) within 30 days prior to study entry * Pregnant or breast-feeding female * Clinically significant abnormal laboratory tests as determined by the principal investigator * An employee of the study site directly involved with the study * Inability to comply with assigned treatment regimen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Up to 28 days | Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | days 14, 28, 34 | Data summarizes plaque index scores changes from baseline. Supragingival plaque will be assessed after the MGI and BOP assessments and following use of a disclosing solution on the facial (buccal) and lingual surfaces of a minimum of 16 scorable teeth according to the criteria of the Turesky modification of the Quigley-Hein Plaque Index. Quigley-Hein Plaque Index Scores with Turesky Modifications: 0 No plaque 1. Separate flecks of plaque at the cervical margin of the tooth 2. A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth 3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth 4. Plaque covering at least one-third but less than two thirds of the crown of the tooth 5. Plaque covering two-thirds or more of the crown of the tooth |
| Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | days 14, 28, 34 | Data summarizes gingival index scores changes from baseline in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP) The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. Modified Gingival Index Scores: 0 Absence of inflammation 1. Mild inflammation; slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit 2. Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit 3. Moderate inflammation; glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit 4. Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. |
| Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | days 0, 14, 28, 34 | Proof of concept of KSL-W in reducing plaque as measured by percent of bleeding sites upon probing (BOP) in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP). The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. The Gingival Bleeding Index assesses the percentage of sites that bleed on gentle probing. A periodontal probe (HU-Friedy UNC 15) will be gently inserted into the gingival sulcus until resistance is felt at mid-facial (buccal), mid-lingual, mesial, and distal interproximal sites of all scorable teeth, with the exception of the most posterior distal sites. Presence or absence of bleeding will be recorded for each site and the percentage of bleeding sites per subject will serve as the unit of analysis. |
Countries
United States
Participant flow
Recruitment details
There were a total of 137 planned subjects (71 in Phase 1 and 66 in Phase 2) to participate in this study at the Oral Health Research Institute, Indiana University School of Dentistry. There were a total of 135 enrolled (71 in Phase 1 and 64 in Phase 2). Phase 1 and 2 are individual periods ran in parallel.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1, 1a (2mg) Subjects from phase 1, 1a (2mg) group | 2 |
| Phase 1, 1a Placebo Subjects from phase 1, 1a placebo group | 1 |
| Phase 1, 2a (4mg) Subjects from phase 1, 2a (4mg) group | 4 |
| Phase 1, 2a Placebo Subjects from phase 1, 2a (4mg) group | 2 |
| Phase 1, 3a (6mg) Subject from phase 1, 3a (6mg) group | 4 |
| Phase 1, 3a Placebo Subjects from phase 1, 3a placebo gorup | 2 |
| Phase 1, 4a (10mg) Subjects from phase 1, 4a (10mg) group | 4 |
| Phase 1, 4a Placebo Subjects from phase 1, 4a placebo group | 2 |
| Phase 1, 5a (20mg) Subjects from phase 1, 5a (20mg) group | 7 |
| Phase 1, 5a Placebo Subjects from phase1, 5a placebo group | 3 |
| Phase 1, 6a (30mg) Subjects from phase 1, 6a (30mg) group | 7 |
| Phase 1, 6a Placebo Subjects from phase 1, 6a placebo group | 3 |
| Phase 1, 7a (50mg) Subjects from phase 1, 7a (50mg) group | 7 |
| Phase 1, 7a Placebo Subjects from phase 1, 7a placebo group | 3 |
| Phase 1, 8a (75mg) Subjects from phase 1, 8a (75mg) group | 7 |
| Phase 1, 8a Placebo Subjects from phase 1, 8a placebo group | 3 |
| Phase 1, 9a (100mg) Subjects from phase 1, 9a (100mg) group | 7 |
| Phase 1, 9a Placebo Subjects from phase 1, 9a placebo group | 3 |
| Phase 2, 1b (4mg) Subjects from phase 2, 1b (4mg) group | 4 |
| Phase 2, 1b Placebo Subjects from phase 2, 1b placebo | 2 |
| Phase 2, 2b (6mg) Subjects from phase 2, 2b (6mg) group | 7 |
| Phase 2, 2b Placebo Subjects from phase 2, 2b placebo group | 3 |
| Phase 2, 3b (10mg) Subjects from phase 2, 3b (10mg) group | 7 |
| Phase 2, 3b Placebo Subjects from phase 2, 3b placebo group | 2 |
| Phase 2, 4b (20mg) Subjects from phase 2, 4b (20mg) group | 6 |
| Phase 2, 4b Placebo Subjects from phase 2, 4b placebo group | 3 |
| Phase 2, 5b (30mg) Subjects from phase 2, 5b (30mg) group | 7 |
| Phase 2, 5b Placebo Subjects from phase 2, 5b placebo group | 3 |
| Phase 2, 6b (50mg) Subjects from phase 2, 6b (50mg) group | 7 |
| Phase 2, 6b Placebo Subjects from phase 2, 6b placebo group | 3 |
| Phase 2, 7b (75mg) Subjects from phase 2, 7b (75mg) group | 7 |
| Phase 2, 7b Placebo Subjects from phase 2, 7b placebo group | 3 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 2 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase 2 | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Phase 2, 4b Placebo | Phase 2, 5b (30mg) | Phase 1, 3a (6mg) | Phase 2, 5b Placebo | Phase 1, 2a Placebo | Phase 1, 7a Placebo | Phase 1, 7a (50mg) | Phase 1, 2a (4mg) | Phase 2, 6b (50mg) | Phase 1, 9a (100mg) | Phase 1, 9a Placebo | Phase 2, 1b (4mg) | Phase 1, 8a (75mg) | Phase 1, 1a (2mg) | Phase 1, 5a Placebo | Total | Phase 1, 6a Placebo | Phase 2, 1b Placebo | Phase 1, 8a Placebo | Phase 1, 6a (30mg) | Phase 1, 5a (20mg) | Phase 2, 2b (6mg) | Phase 1, 4a Placebo | Phase 1, 1a Placebo | Phase 2, 7b (75mg) | Phase 2, 2b Placebo | Phase 1, 4a (10mg) | Phase 2, 3b (10mg) | Phase 2, 3b Placebo | Phase 2, 4b (20mg) | Phase 2, 6b Placebo | Phase 2, 7b Placebo | Phase 1, 3a Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 13.6 | 21.3 years STANDARD_DEVIATION 4.8 | 29.8 years STANDARD_DEVIATION 5.1 | 24.0 years STANDARD_DEVIATION 5 | 41.5 years STANDARD_DEVIATION 2.1 | 35.0 years STANDARD_DEVIATION 19.1 | 27.4 years STANDARD_DEVIATION 7.5 | 31.8 years STANDARD_DEVIATION 5.5 | 37.3 years STANDARD_DEVIATION 13.9 | 26.4 years STANDARD_DEVIATION 10.4 | 33.7 years STANDARD_DEVIATION 20.6 | 31.5 years STANDARD_DEVIATION 11.4 | 29.3 years STANDARD_DEVIATION 6.7 | 45.5 years STANDARD_DEVIATION 0.7 | 49.7 years STANDARD_DEVIATION 9.5 | 21.3 years STANDARD_DEVIATION 0 | 36.0 years STANDARD_DEVIATION 5.6 | 36.5 years STANDARD_DEVIATION 16.3 | 44.7 years STANDARD_DEVIATION 13.6 | 36.7 years STANDARD_DEVIATION 8.9 | 38.0 years STANDARD_DEVIATION 14.3 | 38.1 years STANDARD_DEVIATION 12.2 | 44.0 years STANDARD_DEVIATION 11.3 | 49.0 years | 26.0 years STANDARD_DEVIATION 5 | 22.0 years STANDARD_DEVIATION 3.6 | 44.5 years STANDARD_DEVIATION 5 | 25.7 years STANDARD_DEVIATION 5.8 | 33.0 years STANDARD_DEVIATION 15.6 | 30.2 years STANDARD_DEVIATION 14.3 | 26.0 years STANDARD_DEVIATION 10.4 | 21.7 years STANDARD_DEVIATION 0.6 | 40.0 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 13 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 7 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 7 Participants | 4 Participants | 7 Participants | 4 Participants | 2 Participants | 3 Participants | 7 Participants | 2 Participants | 3 Participants | 122 Participants | 3 Participants | 2 Participants | 2 Participants | 6 Participants | 3 Participants | 7 Participants | 2 Participants | 1 Participants | 6 Participants | 3 Participants | 4 Participants | 7 Participants | 2 Participants | 6 Participants | 3 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 14 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 22 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 4 Participants | 2 Participants | 2 Participants | 3 Participants | 5 Participants | 3 Participants | 6 Participants | 4 Participants | 1 Participants | 2 Participants | 6 Participants | 0 Participants | 2 Participants | 95 Participants | 3 Participants | 2 Participants | 2 Participants | 5 Participants | 7 Participants | 4 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 4 Participants | 1 Participants | 6 Participants | 2 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 3 participants | 7 participants | 4 participants | 3 participants | 2 participants | 3 participants | 7 participants | 4 participants | 7 participants | 7 participants | 3 participants | 4 participants | 7 participants | 2 participants | 3 participants | 135 participants | 3 participants | 2 participants | 3 participants | 7 participants | 7 participants | 7 participants | 2 participants | 1 participants | 7 participants | 3 participants | 4 participants | 7 participants | 2 participants | 6 participants | 3 participants | 3 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 6 Participants | 3 Participants | 5 Participants | 5 Participants | 2 Participants | 1 Participants | 5 Participants | 2 Participants | 1 Participants | 76 Participants | 3 Participants | 0 Participants | 3 Participants | 5 Participants | 4 Participants | 5 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 2 Participants | 59 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants | 2 Participants | 4 Participants | 6 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 4 | 0 / 2 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 2 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 1 | 0 / 4 | 0 / 2 | 0 / 4 | 1 / 2 | 0 / 4 | 1 / 2 | 1 / 7 | 2 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 2 / 7 | 0 / 3 | 2 / 7 | 0 / 3 | 2 / 4 | 1 / 2 | 3 / 7 | 1 / 3 | 3 / 7 | 0 / 2 | 1 / 6 | 2 / 3 | 5 / 7 | 2 / 3 | 5 / 7 | 1 / 3 | 5 / 7 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 4 | 0 / 2 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 2 | 0 / 6 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 7 | 0 / 3 |
Outcome results
Primary
Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs)
Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs)
Time frame: Up to 28 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1, 1a (2mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 2 Participants |
| Phase 1, 1a (2mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 1a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 1a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 1 Participants |
| Phase 1, 2a (4mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 4 Participants |
| Phase 1, 2a (4mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 2a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 2a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 2 Participants |
| Phase 1, 3a (6mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 4 Participants |
| Phase 1, 3a (6mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 3a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 1 Participants |
| Phase 1, 3a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 1 Participants |
| Phase 1, 4a (10mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 4 Participants |
| Phase 1, 4a (10mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 4a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 1 Participants |
| Phase 1, 4a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 1 Participants |
| Phase 1, 5a (20mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 6 Participants |
| Phase 1, 5a (20mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 1 Participants |
| Phase 1, 5a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 1 Participants |
| Phase 1, 5a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 2 Participants |
| Phase 1, 6a (30mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 7 Participants |
| Phase 1, 6a (30mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 6a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 6a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 3 Participants |
| Phase 1, 7a (50mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 7a (50mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 7 Participants |
| Phase 1, 7a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 7a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 3 Participants |
| Phase 1, 8a (75mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 5 Participants |
| Phase 1, 8a (75mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 2 Participants |
| Phase 1, 8a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 1, 8a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 3 Participants |
| Phase 1, 9a (100mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 5 Participants |
| Phase 1, 9a (100mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 2 Participants |
| Phase 1, 9a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 3 Participants |
| Phase 1, 9a Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 2, 1b (4mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 2 Participants |
| Phase 2, 1b (4mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 2 Participants |
| Phase 2, 1b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 1 Participants |
| Phase 2, 1b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 1 Participants |
| Phase 2, 2b (6mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 3 Participants |
| Phase 2, 2b (6mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 4 Participants |
| Phase 2, 2b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 1 Participants |
| Phase 2, 2b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 2 Participants |
| Phase 2, 3b (10mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 3 Participants |
| Phase 2, 3b (10mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 4 Participants |
| Phase 2, 3b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 2, 3b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 2 Participants |
| Phase 2, 4b (20mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 5 Participants |
| Phase 2, 4b (20mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 1 Participants |
| Phase 2, 4b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 1 Participants |
| Phase 2, 4b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 2 Participants |
| Phase 2, 5b (30mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 5 Participants |
| Phase 2, 5b (30mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 2 Participants |
| Phase 2, 5b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 1 Participants |
| Phase 2, 5b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 2 Participants |
| Phase 2, 6b (50mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 2 Participants |
| Phase 2, 6b (50mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 5 Participants |
| Phase 2, 6b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 1 Participants |
| Phase 2, 6b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 2 Participants |
| Phase 2, 7b (75mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 2 Participants |
| Phase 2, 7b (75mg) | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 5 Participants |
| Phase 2, 7b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subjects Experiencing AEs = YES | 0 Participants |
| Phase 2, 7b Placebo | Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs) | Subject Experiencing AEs = NO | 3 Participants |
Secondary
Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a
Proof of concept of KSL-W in reducing plaque as measured by percent of bleeding sites upon probing (BOP) in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP). The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. The Gingival Bleeding Index assesses the percentage of sites that bleed on gentle probing. A periodontal probe (HU-Friedy UNC 15) will be gently inserted into the gingival sulcus until resistance is felt at mid-facial (buccal), mid-lingual, mesial, and distal interproximal sites of all scorable teeth, with the exception of the most posterior distal sites. Presence or absence of bleeding will be recorded for each site and the percentage of bleeding sites per subject will serve as the unit of analysis.
Time frame: days 0, 14, 28, 34
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 16 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 23 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 16 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 22 Percent of bleeding sites | Standard Deviation 26 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 25 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 20 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 16 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 16 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 20 Percent of bleeding sites | Standard Deviation 24 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 16 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 19 Percent of bleeding sites | Standard Deviation 25 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 17 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 17 Percent of bleeding sites | Standard Deviation 22 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 21 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 19 Percent of bleeding sites | Standard Deviation 23 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 25 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 19 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 14 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 19 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 23 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 18 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 14 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 13 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 15 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 12 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 24 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 21 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 25 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 16 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 20 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 16 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 16 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 16 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 15 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 1a (2mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 22 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 29 Percent of bleeding sites | Standard Deviation 32 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 35 Percent of bleeding sites | Standard Deviation 36 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 40 Percent of bleeding sites | Standard Deviation 32 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 26 Percent of bleeding sites | Standard Deviation 25 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 26 Percent of bleeding sites | Standard Deviation 29 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 46 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 26 Percent of bleeding sites | Standard Deviation 29 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 37 Percent of bleeding sites | Standard Deviation 31 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 34 Percent of bleeding sites | Standard Deviation 26 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 28 Percent of bleeding sites | Standard Deviation 28 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 39 Percent of bleeding sites | Standard Deviation 28 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 45 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 27 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 52 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 30 Percent of bleeding sites | Standard Deviation 29 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 34 Percent of bleeding sites | Standard Deviation 22 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 24 Percent of bleeding sites | Standard Deviation 29 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 27 Percent of bleeding sites | Standard Deviation 26 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 23 Percent of bleeding sites | Standard Deviation 29 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 39 Percent of bleeding sites | Standard Deviation 39 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 43 Percent of bleeding sites | Standard Deviation 32 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 37 Percent of bleeding sites | Standard Deviation 37 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 45 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 27 Percent of bleeding sites | Standard Deviation 34 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 18 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 46 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 32 Percent of bleeding sites | Standard Deviation 32 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 28 Percent of bleeding sites | Standard Deviation 24 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 21 Percent of bleeding sites | Standard Deviation 24 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 24 Percent of bleeding sites | Standard Deviation 23 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 39 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 30 Percent of bleeding sites | Standard Deviation 29 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 54 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 19 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 1a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 32 Percent of bleeding sites | Standard Deviation 26 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 26 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 18 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 17 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 25 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 26 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 20 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 28 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 25 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 29 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 32 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 20 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 26 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 22 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 32 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 19 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 30 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 26 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 23 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 19 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 29 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 15 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 36 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 21 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 26 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 22 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 28 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 29 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 31 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 22 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 21 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 32 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 27 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 25 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 22 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 2a (4mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 30 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 27 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 30 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 18 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 15 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 17 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 21 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 26 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 28 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 30 Percent of bleeding sites | Standard Deviation 23 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 25 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 26 Percent of bleeding sites | Standard Deviation 23 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 18 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 24 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 29 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 20 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 27 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 34 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 28 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 32 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 31 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 27 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 22 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 16 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 29 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 24 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 19 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 16 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 22 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 22 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 23 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 33 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 15 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 23 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 19 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 2a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 20 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 16 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 20 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 20 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 19 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 23 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 22 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 5 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 21 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 19 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 11 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 24 Percent of bleeding sites | Standard Deviation 27 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 17 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 11 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 12 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 22 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 17 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 10 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 16 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 11 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 23 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 17 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 20 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 13 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 21 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 16 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 16 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 17 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 16 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 17 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 15 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 19 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 17 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 15 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 19 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 3a (6mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 15 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 21 Percent of bleeding sites | Standard Deviation 2 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 33 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 15 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 32 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 21 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 29 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 26 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 20 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 17 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 27 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 29 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 33 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 21 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 38 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 12 Percent of bleeding sites | Standard Deviation 2 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 34 Percent of bleeding sites | Standard Deviation 30 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 26 Percent of bleeding sites | Standard Deviation 1 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 20 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 30 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 26 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 17 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 31 Percent of bleeding sites | Standard Deviation 32 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 26 Percent of bleeding sites | Standard Deviation 27 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 36 Percent of bleeding sites | Standard Deviation 34 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 23 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 27 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 30 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 34 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 18 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 29 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 29 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 28 Percent of bleeding sites | Standard Deviation 27 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 30 Percent of bleeding sites | Standard Deviation 26 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 25 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 3a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 14 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 32 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 31 Percent of bleeding sites | Standard Deviation 22 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 42 Percent of bleeding sites | Standard Deviation 26 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 36 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 24 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 35 Percent of bleeding sites | Standard Deviation 23 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 30 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 29 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 25 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 33 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 31 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 33 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 31 Percent of bleeding sites | Standard Deviation 28 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 29 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 31 Percent of bleeding sites | Standard Deviation 23 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 37 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 34 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 31 Percent of bleeding sites | Standard Deviation 22 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 28 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 27 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 26 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 21 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 34 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 34 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 34 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 30 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 24 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 22 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 28 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 34 Percent of bleeding sites | Standard Deviation 22 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 19 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 23 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 38 Percent of bleeding sites | Standard Deviation 26 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 37 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 4a (10mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 39 Percent of bleeding sites | Standard Deviation 22 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 35 Percent of bleeding sites | Standard Deviation 28 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 36 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 28 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 31 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 34 Percent of bleeding sites | Standard Deviation 26 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 30 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 33 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 39 Percent of bleeding sites | Standard Deviation 23 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 29 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 44 Percent of bleeding sites | Standard Deviation 29 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 23 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 36 Percent of bleeding sites | Standard Deviation 25 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 36 Percent of bleeding sites | Standard Deviation 28 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 33 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 36 Percent of bleeding sites | Standard Deviation 30 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 33 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 27 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 34 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 38 Percent of bleeding sites | Standard Deviation 32 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 30 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 45 Percent of bleeding sites | Standard Deviation 33 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 33 Percent of bleeding sites | Standard Deviation 31 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 39 Percent of bleeding sites | Standard Deviation 34 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 41 Percent of bleeding sites | Standard Deviation 29 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 35 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 37 Percent of bleeding sites | Standard Deviation 23 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 37 Percent of bleeding sites | Standard Deviation 26 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 27 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 34 Percent of bleeding sites | Standard Deviation 28 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 35 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 35 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 38 Percent of bleeding sites | Standard Deviation 28 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 33 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 37 Percent of bleeding sites | Standard Deviation 22 |
| Phase 1, 4a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 38 Percent of bleeding sites | Standard Deviation 25 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 31 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 28 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 25 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 25 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 31 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 28 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 25 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 22 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 231 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 22 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 24 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 25 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 28 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 29 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 22 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 32 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 22 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 32 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 26 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 23 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 26 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 30 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 22 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 21 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 24 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 30 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 26 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 27 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 25 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 26 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 24 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 36 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 23 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 24 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 5a (20mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 22 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 25 Percent of bleeding sites | Standard Deviation 22 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 26 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 21 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 13 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 16 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 17 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 20 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 17 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 17 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 25 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 22 Percent of bleeding sites | Standard Deviation 2 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 12 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 14 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 10 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 24 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 19 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 20 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 20 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 19 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 17 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 17 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 11 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 19 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 27 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 27 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 17 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 10 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 13 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 19 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 13 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 22 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 25 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 29 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 21 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 5a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 21 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 17 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 20 Percent of bleeding sites | Standard Deviation 22 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 20 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 10 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 32 Percent of bleeding sites | Standard Deviation 24 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 22 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 18 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 25 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 29 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 23 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 20 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 18 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 11 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 22 Percent of bleeding sites | Standard Deviation 23 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 13 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 11 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 19 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 25 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 19 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 23 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 17 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 13 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 15 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 24 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 24 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 16 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 9 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 16 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 10 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 8 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 25 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 27 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 20 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 23 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 6a (30mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 23 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 27 Percent of bleeding sites | Standard Deviation 28 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 24 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 34 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 27 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 28 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 17 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 19 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 25 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 16 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 36 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 39 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 33 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 33 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 30 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 22 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 34 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 21 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 22 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 22 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 22 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 27 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 27 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 29 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 36 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 24 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 32 Percent of bleeding sites | Standard Deviation 1 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 35 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 27 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 35 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 30 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 25 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 31 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 32 Percent of bleeding sites | Standard Deviation 20 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 32 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 6a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 21 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 19 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 16 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 21 Percent of bleeding sites | Standard Deviation 14 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 14 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 17 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 24 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 19 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 19 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 12 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 16 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 25 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 17 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 21 Percent of bleeding sites | Standard Deviation 16 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 15 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 20 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 22 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 11 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 14 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 16 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 16 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 20 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 258 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 24 Percent of bleeding sites | Standard Deviation 19 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 14 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 21 Percent of bleeding sites | Standard Deviation 15 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 24 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 18 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 24 Percent of bleeding sites | Standard Deviation 21 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 23 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 10 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 22 Percent of bleeding sites | Standard Deviation 17 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 13 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 22 Percent of bleeding sites | Standard Deviation 18 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 17 Percent of bleeding sites | Standard Deviation 8 |
| Phase 1, 7a (50mg) | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 23 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 0 | 20 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Eligibility | 14 Percent of bleeding sites | Standard Deviation 10 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Eligibility | 11 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Eligibility | 10 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Eligibility | 15 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 0 | 22 Percent of bleeding sites | Standard Deviation 1 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 14 | 19 Percent of bleeding sites | Standard Deviation 13 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 34 | 23 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 34 | 27 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 34 | 21 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 28 | 16 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 14 | 11 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 14 | 17 Percent of bleeding sites | Standard Deviation 11 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Eligibility | 12 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Day 28 | 20 Percent of bleeding sites | Standard Deviation 2 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 34 | 17 Percent of bleeding sites | Standard Deviation 2 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 28 | 11 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 34 | 25 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 0 | 17 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 14 | 15 Percent of bleeding sites | Standard Deviation 9 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 14 | 15 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 14 | 15 Percent of bleeding sites | Standard Deviation 6 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 28 | 6 Percent of bleeding sites | Standard Deviation 0 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 34 | 20 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 14 | 16 Percent of bleeding sites | Standard Deviation 12 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Day 28 | 15 Percent of bleeding sites | Standard Deviation 4 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Mandibular: Day 0 | 13 Percent of bleeding sites | Standard Deviation 3 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Lingual: Eligibility | 13 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Maxillary: Eligibility | 8 Percent of bleeding sites | Standard Deviation 5 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Whole Mouth: Day 28 | 13 Percent of bleeding sites | Standard Deviation 1 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 0 | 19 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Posterior: Day 28 | 14 Percent of bleeding sites | Standard Deviation 0 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Interproximal: Day 0 | 20 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 0 | 12 Percent of bleeding sites | Standard Deviation 7 |
| Phase 1, 7a Placebo | Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a | Facial: Day 34 | 18 Percent of bleeding sites | Standard Deviation 11 |
Secondary
Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a
Data summarizes gingival index scores changes from baseline in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP) The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. Modified Gingival Index Scores: 0 Absence of inflammation 1. Mild inflammation; slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit 2. Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit 3. Moderate inflammation; glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit 4. Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.
Time frame: days 14, 28, 34
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | 0.04 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | 0.09 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | 0.01 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | -0.10 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | -0.03 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | 0.10 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | 0.00 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | 0.02 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | 0.13 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | 0.17 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | 0.01 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | -0.03 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | 0.18 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | 0.02 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | 0.05 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | 0.06 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | -0.06 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | 0.00 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | 0.00 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | 0.19 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | -0.02 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | 0.07 scores on a scale | Standard Deviation 0.01 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | -0.08 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | 0.09 scores on a scale | Standard Deviation 0.01 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | 0.02 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | -0.05 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | 0.04 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | 0.02 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | -0.05 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | -0.06 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | -0.06 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | 0.01 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | -0.05 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | 0.05 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | 0.10 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | -0.06 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | 0.04 scores on a scale | Standard Deviation 0.02 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | 0.02 scores on a scale | Standard Deviation 0.02 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | -0.03 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | 0.00 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | 0.05 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | 0.02 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | 0.01 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | 0.02 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | -0.02 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | 0.00 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | 0.00 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | 0.00 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | 0.00 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | -0.01 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | 0.01 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | 0.05 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | 0.00 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | -0.02 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | -0.02 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | 0.00 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | 0.00 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | -0.04 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | -0.01 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | 0.01 scores on a scale | Standard Deviation 0.047 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | 0.03 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | 0.00 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | 0.01 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | 0.10 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | 0.01 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | 0.05 scores on a scale | Standard Deviation 0.02 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | 0.05 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | 0.06 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | 0.10 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | 0.01 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | 0.08 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | 0.12 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | 0.15 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | 0.14 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | 0.06 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | 0.12 scores on a scale | Standard Deviation 0.18 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | 0.10 scores on a scale | Standard Deviation 0.047 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | 0.18 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | 0.06 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | 0.06 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | 0.03 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | 0.10 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | 0.11 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | 0.02 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | 0.05 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | 0.02 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | 0.05 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | -0.06 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | 0.06 scores on a scale | Standard Deviation 0.17 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | -0.03 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | -0.05 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | 0.04 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | 0.02 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | 0.07 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | 0.00 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | -0.06 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | -0.05 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | 0.03 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | -0.04 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | 0.01 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | 0.04 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | 0.06 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | 0.02 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | 0.04 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | -0.03 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | 0.10 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | 0.09 scores on a scale | Standard Deviation 0.01 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | 0.16 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | -0.02 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | 0.15 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | 0.08 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | 0.10 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | 0.02 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | 0.05 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | 0.19 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | 0.01 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | 0.12 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | 0.14 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | 0.07 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | 0.10 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | 0.16 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | 0.19 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | 0.11 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | -0.05 scores on a scale | Standard Deviation 0.02 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | 0.11 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | 0.09 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | 0.08 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | 0.05 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | 0.00 scores on a scale | Standard Deviation 0.02 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | 0.12 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | 0.06 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | 0.01 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | -0.01 scores on a scale | Standard Deviation 0.02 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | 0.01 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | 0.04 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | 0.00 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | 0.01 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | 0.01 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | 0.09 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | 0.01 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | 0.00 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | 0.07 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | 0.07 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | 0.08 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | 0.07 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | 0.05 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | 0.03 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | 0.10 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | 0.05 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | 0.08 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | -0.03 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | -0.02 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | 0.03 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | -0.09 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | 0.13 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | 0.12 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | 0.03 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | 0.03 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | -0.04 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | 0.08 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | 0.10 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | 0.00 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | 0.05 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | 0.10 scores on a scale | Standard Deviation 0 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | -0.07 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | 0.06 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | 0.06 scores on a scale | Standard Deviation 0.25 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | 0.01 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | -0.12 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | -0.10 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | -0.08 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | -0.17 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | -0.10 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | -0.10 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | -0.15 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | -0.11 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | -0.15 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | -0.11 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | -0.14 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | -0.13 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | -0.13 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | -0.11 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | -0.14 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | -0.12 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | -0.15 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | -0.13 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | -0.14 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | -0.15 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | -0.11 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | -0.17 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | -0.09 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | -0.09 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | -0.12 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | -0.19 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | -0.09 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | -0.05 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | -0.12 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | -0.15 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | -0.08 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | -0.06 scores on a scale | Standard Deviation 0.17 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | -0.12 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | -0.05 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | -0.09 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | -0.10 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | -0.03 scores on a scale | Standard Deviation 0.18 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | -0.10 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | 0.13 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | -0.15 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | -0.14 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | -0.17 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | 0.04 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | 0.00 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | -0.01 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | -0.01 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | 0.01 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | -0.04 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | -0.02 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | -0.02 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | -0.06 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | -0.06 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | -0.05 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | 0.00 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | -0.01 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | -0.06 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | -0.03 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | -0.04 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | 0.00 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | -0.02 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | 0.01 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | -0.03 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | -0.03 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | -0.04 scores on a scale | Standard Deviation 0.25 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | -0.01 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | -0.11 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | -0.12 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | 0.01 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | 0.03 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | 0.04 scores on a scale | Standard Deviation 0.22 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | -0.09 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | -0.12 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | -0.12 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | -0.15 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | -0.09 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | -0.08 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | -0.07 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | -0.10 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | -0.04 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | -0.05 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | -0.08 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | -0.07 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | 0.00 scores on a scale | Standard Deviation 0.18 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | -0.11 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | -0.06 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | -0.11 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | -0.11 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | -0.11 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | -0.17 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | -0.13 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | -0.07 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | -0.05 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | -0.07 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | -0.14 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | -0.11 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | -0.08 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | -0.05 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | -0.10 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | -0.12 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | 0.01 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | -0.10 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | -0.02 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | -0.04 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | -0.07 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | -0.12 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 14 | -0.05 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 28 | 0.09 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 34 | 0.14 scores on a scale | Standard Deviation 0.01 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 14 | 0.02 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 28 | 0.08 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 28 | 0.10 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Facial: Day 34 | 0.19 scores on a scale | Standard Deviation 0 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 28 | 0.08 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 34 | 0.16 scores on a scale | Standard Deviation 0 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 14 | 0.05 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 34 | 0.17 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 28 | 0.12 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 14 | 0.00 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 14 | -0.06 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Posterior: Day 34 | 0.15 scores on a scale | Standard Deviation 0.01 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Lingual: Day 28 | 0.15 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 34 | 0.16 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Whole Mouth: Day 14 | 0.00 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Interproximal: Day 34 | 0.18 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Mandibular: Day 14 | -0.02 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a | Maxillary: Day 28 | 0.15 scores on a scale | Standard Deviation 0.06 |
Secondary
Proof of Concept of KSL-W in Reducing Plaque in Phase 2a
Data summarizes plaque index scores changes from baseline. Supragingival plaque will be assessed after the MGI and BOP assessments and following use of a disclosing solution on the facial (buccal) and lingual surfaces of a minimum of 16 scorable teeth according to the criteria of the Turesky modification of the Quigley-Hein Plaque Index. Quigley-Hein Plaque Index Scores with Turesky Modifications: 0 No plaque 1. Separate flecks of plaque at the cervical margin of the tooth 2. A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth 3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth 4. Plaque covering at least one-third but less than two thirds of the crown of the tooth 5. Plaque covering two-thirds or more of the crown of the tooth
Time frame: days 14, 28, 34
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | 0.33 scores on a scale | Standard Deviation 0.36 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | 0.14 scores on a scale | Standard Deviation 0.26 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | 0.27 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | 0.25 scores on a scale | Standard Deviation 0.44 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | 0.22 scores on a scale | Standard Deviation 0.24 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | 0.22 scores on a scale | Standard Deviation 0.24 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | 0.30 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | 0.20 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | 0.52 scores on a scale | Standard Deviation 0.65 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | 0.41 scores on a scale | Standard Deviation 0.46 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | 0.19 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | 0.21 scores on a scale | Standard Deviation 0.31 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | 0.20 scores on a scale | Standard Deviation 0.3 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | 0.21 scores on a scale | Standard Deviation 0.44 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | 0.10 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | 0.24 scores on a scale | Standard Deviation 0.174 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | 0.41 scores on a scale | Standard Deviation 0.51 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | 0.25 scores on a scale | Standard Deviation 0.31 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | 0.37 scores on a scale | Standard Deviation 0.42 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | 0.39 scores on a scale | Standard Deviation 0.34 |
| Phase 1, 1a (2mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | 0.30 scores on a scale | Standard Deviation 0.47 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | -0.04 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | -0.17 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | -0.18 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | -0.06 scores on a scale | Standard Deviation 0.02 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | 0.02 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | 0.06 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | -0.11 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | -0.14 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | 0.14 scores on a scale | Standard Deviation 0.02 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | 0.02 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | 0.00 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | -0.26 scores on a scale | Standard Deviation 0.27 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | -0.08 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | 0.00 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | -0.13 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | -0.01 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | -0.03 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | -0.20 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | -0.02 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | 0.04 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 1a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | 0.03 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | -0.20 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | -0.19 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | -0.20 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | -0.12 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | -0.23 scores on a scale | Standard Deviation 0.2 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | -0.16 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | -0.17 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | -0.20 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | -0.08 scores on a scale | Standard Deviation 0.24 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | -0.22 scores on a scale | Standard Deviation 0.28 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | -0.11 scores on a scale | Standard Deviation 0.28 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | -0.12 scores on a scale | Standard Deviation 0.24 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | -0.24 scores on a scale | Standard Deviation 0.22 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | -0.17 scores on a scale | Standard Deviation 0.23 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | -0.19 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | -0.20 scores on a scale | Standard Deviation 0.22 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | -0.18 scores on a scale | Standard Deviation 0.2 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | -0.18 scores on a scale | Standard Deviation 0.27 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | -0.07 scores on a scale | Standard Deviation 0.17 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | -0.12 scores on a scale | Standard Deviation 0.29 |
| Phase 1, 2a (4mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | -0.30 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | -0.02 scores on a scale | Standard Deviation 0.38 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | -0.16 scores on a scale | Standard Deviation 0.41 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | -0.16 scores on a scale | Standard Deviation 0.54 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | -0.16 scores on a scale | Standard Deviation 0.54 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | -0.09 scores on a scale | Standard Deviation 0.47 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | -0.03 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | -0.16 scores on a scale | Standard Deviation 0.32 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | 0.03 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | -0.10 scores on a scale | Standard Deviation 0.36 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | -0.16 scores on a scale | Standard Deviation 0.43 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | 0.08 scores on a scale | Standard Deviation 0.23 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | -0.06 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | -0.17 scores on a scale | Standard Deviation 0.4 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | 0.01 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | 0.08 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | 0.11 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | -0.16 scores on a scale | Standard Deviation 0.32 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | 0.08 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | 0.11 scores on a scale | Standard Deviation 0.31 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | 0.06 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 2a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | -0.10 scores on a scale | Standard Deviation 0.39 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | -0.05 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | 0.37 scores on a scale | Standard Deviation 0.34 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | 0.13 scores on a scale | Standard Deviation 0.24 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | 0.09 scores on a scale | Standard Deviation 0.2 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | -0.02 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | 0.14 scores on a scale | Standard Deviation 0.23 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | 0.24 scores on a scale | Standard Deviation 0.24 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | 0.26 scores on a scale | Standard Deviation 0.3 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | 0.014 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | 0.07 scores on a scale | Standard Deviation 0.18 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | 0.25 scores on a scale | Standard Deviation 0.26 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | 0.09 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | 0.19 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | 0.24 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | 0.22 scores on a scale | Standard Deviation 0.26 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | 0.28 scores on a scale | Standard Deviation 0.28 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | 0.28 scores on a scale | Standard Deviation 0.4 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | 0.24 scores on a scale | Standard Deviation 0.29 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | -0.06 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | 0.01 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 3a (6mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | 0.24 scores on a scale | Standard Deviation 0.25 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | 0.10 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | -0.01 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | 0.10 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | 0.12 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | -0.01 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | 0.17 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | -0.01 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | 0.06 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | 0.06 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | -0.02 scores on a scale | Standard Deviation 0.01 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | 0.09 scores on a scale | Standard Deviation 0.06 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | 0.13 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | -0.12 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | 0.00 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | 0.00 scores on a scale | Standard Deviation 0.31 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | 0.04 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | 0.02 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | 0.05 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | -0.03 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | 0.03 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 3a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | 0.06 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | -0.19 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | -0.22 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | -0.06 scores on a scale | Standard Deviation 0.17 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | -0.10 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | -0.25 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | -0.05 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | -0.32 scores on a scale | Standard Deviation 0.18 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | -0.08 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | -0.07 scores on a scale | Standard Deviation 0.24 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | -0.07 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | -0.10 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | -0.11 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | -0.08 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | -0.11 scores on a scale | Standard Deviation 0.04 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | -0.08 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | -0.22 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | -0.04 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | -0.10 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | -0.20 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | -0.09 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 4a (10mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | -0.08 scores on a scale | Standard Deviation 0.02 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | 0.02 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | 0.06 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | 0.00 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | 0.04 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | 0.09 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | -0.06 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | 0.03 scores on a scale | Standard Deviation 0.05 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | 0.08 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | 0.03 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | 0.01 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | -0.02 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | 0.00 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | 0.06 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | 0.01 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | -0.02 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | -0.02 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | -0.02 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | 0.03 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | 0.03 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | -0.05 scores on a scale | Standard Deviation 0.24 |
| Phase 1, 4a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | -0.04 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | -0.23 scores on a scale | Standard Deviation 0.18 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | -0.43 scores on a scale | Standard Deviation 0.26 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | -0.18 scores on a scale | Standard Deviation 0.35 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | -0.49 scores on a scale | Standard Deviation 0.43 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | -0.27 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | -0.40 scores on a scale | Standard Deviation 0.36 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | -0.16 scores on a scale | Standard Deviation 0.43 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | -0.64 scores on a scale | Standard Deviation 0.41 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | -0.24 scores on a scale | Standard Deviation 0.28 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | -0.45 scores on a scale | Standard Deviation 0.33 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | -0.35 scores on a scale | Standard Deviation 0.31 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | -0.20 scores on a scale | Standard Deviation 0.28 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | -0.58 scores on a scale | Standard Deviation 0.44 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | -0.08 scores on a scale | Standard Deviation 0.41 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | -0.21 scores on a scale | Standard Deviation 0.26 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | -0.36 scores on a scale | Standard Deviation 0.33 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | -0.60 scores on a scale | Standard Deviation 0.39 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | -0.33 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | -0.31 scores on a scale | Standard Deviation 0.23 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | -1.31 scores on a scale | Standard Deviation 0.31 |
| Phase 1, 5a (20mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | -0.31 scores on a scale | Standard Deviation 0.31 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | -0.07 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | -0.14 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | -0.05 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | -0.04 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | -0.11 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | -0.03 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | -0.01 scores on a scale | Standard Deviation 0.13 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | -0.17 scores on a scale | Standard Deviation 0.058 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | -0.07 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | -0.22 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | -0.14 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | -0.07 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | -0.20 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | -0.21 scores on a scale | Standard Deviation 0.07 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | -0.05 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | -0.06 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | 0.07 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | -0.04 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | -0.16 scores on a scale | Standard Deviation 0.17 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | -0.22 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 5a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | -0.03 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | -0.66 scores on a scale | Standard Deviation 0.3 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | -0.45 scores on a scale | Standard Deviation 0.37 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | -0.53 scores on a scale | Standard Deviation 0.25 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | -0.42 scores on a scale | Standard Deviation 0.2 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | -0.37 scores on a scale | Standard Deviation 0.36 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | -0.50 scores on a scale | Standard Deviation 0.26 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | -0.38 scores on a scale | Standard Deviation 0.28 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | 0.61 scores on a scale | Standard Deviation 0.29 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | -0.53 scores on a scale | Standard Deviation 0.27 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | -0.12 scores on a scale | Standard Deviation 0.32 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | -0.52 scores on a scale | Standard Deviation 0.19 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | -0.18 scores on a scale | Standard Deviation 0.39 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | -0.52 scores on a scale | Standard Deviation 0.25 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | -0.46 scores on a scale | Standard Deviation 0.2 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | -0.47 scores on a scale | Standard Deviation 0.17 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | -0.59 scores on a scale | Standard Deviation 0.23 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | -0.24 scores on a scale | Standard Deviation 0.43 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | -0.20 scores on a scale | Standard Deviation 0.34 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | -0.17 scores on a scale | Standard Deviation 0.36 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | -0.25 scores on a scale | Standard Deviation 0.34 |
| Phase 1, 6a (30mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | -0.18 scores on a scale | Standard Deviation 0.33 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | 0.04 scores on a scale | Standard Deviation 0.18 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | -0.17 scores on a scale | Standard Deviation 0.24 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | -0.21 scores on a scale | Standard Deviation 0.26 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | 0.10 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | 0.06 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | -0.12 scores on a scale | Standard Deviation 0.18 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | 0.06 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | 0.03 scores on a scale | Standard Deviation 0.21 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | 0.02 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | 0.04 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | 0.04 scores on a scale | Standard Deviation 0.18 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | 0.06 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | -0.21 scores on a scale | Standard Deviation 0.24 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | -0.03 scores on a scale | Standard Deviation 0.23 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | -0.21 scores on a scale | Standard Deviation 0.37 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | 0.05 scores on a scale | Standard Deviation 0.15 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | -0.14 scores on a scale | Standard Deviation 0.22 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | 0.13 scores on a scale | Standard Deviation 0.1 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | 0.04 scores on a scale | Standard Deviation 0.17 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | 0.06 scores on a scale | Standard Deviation 0.14 |
| Phase 1, 6a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | -0.22 scores on a scale | Standard Deviation 0.29 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | -0.18 scores on a scale | Standard Deviation 0.44 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | -0.58 scores on a scale | Standard Deviation 0.49 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | -0.18 scores on a scale | Standard Deviation 0.4 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | -0.60 scores on a scale | Standard Deviation 0.55 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | -0.69 scores on a scale | Standard Deviation 0.54 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | -0.60 scores on a scale | Standard Deviation 0.44 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | -0.17 scores on a scale | Standard Deviation 0.38 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | -0.70 scores on a scale | Standard Deviation 0.69 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | -0.62 scores on a scale | Standard Deviation 0.53 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | -0.48 scores on a scale | Standard Deviation 0.38 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | -0.25 scores on a scale | Standard Deviation 0.6 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | -0.23 scores on a scale | Standard Deviation 0.5 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | -0.56 scores on a scale | Standard Deviation 0.56 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | -0.14 scores on a scale | Standard Deviation 0.32 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | -0.47 scores on a scale | Standard Deviation 0.41 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | -0.59 scores on a scale | Standard Deviation 0.52 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | -0.20 scores on a scale | Standard Deviation 0.44 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | -0.48 scores on a scale | Standard Deviation 0.4 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | -0.59 scores on a scale | Standard Deviation 0.54 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | -0.53 scores on a scale | Standard Deviation 0.44 |
| Phase 1, 7a (50mg) | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | -0.67 scores on a scale | Standard Deviation 0.61 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 34 | 0.68 scores on a scale | Standard Deviation 0.31 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 34 | 0.57 scores on a scale | Standard Deviation 0.35 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 28 | 0.22 scores on a scale | Standard Deviation 0.11 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 14 | 0.20 scores on a scale | Standard Deviation 0.23 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 28 | 0.19 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 28 | 0.22 scores on a scale | Standard Deviation 0.16 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 28 | 0.15 scores on a scale | Standard Deviation 0.01 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 34 | 0.53 scores on a scale | Standard Deviation 0.37 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 28 | 0.29 scores on a scale | Standard Deviation 0.2 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 34 | 0.42 scores on a scale | Standard Deviation 0.29 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 14 | 0.28 scores on a scale | Standard Deviation 0.12 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 14 | 0.32 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Mandibular: Day 34 | 0.30 scores on a scale | Standard Deviation 0.32 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Posterior: Day 14 | 0.31 scores on a scale | Standard Deviation 0.17 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 28 | 0.24 scores on a scale | Standard Deviation 0.2 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Lingual: Day 14 | 0.25 scores on a scale | Standard Deviation 0.08 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Interproximal: Day 34 | 0.54 scores on a scale | Standard Deviation 0.4 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 14 | 0.36 scores on a scale | Standard Deviation 0.03 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Maxillary: Day 28 | 0.24 scores on a scale | Standard Deviation 0.09 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Whole Mouth: Day 34 | 0.49 scores on a scale | Standard Deviation 0.32 |
| Phase 1, 7a Placebo | Proof of Concept of KSL-W in Reducing Plaque in Phase 2a | Facial: Day 14 | 0.31 scores on a scale | Standard Deviation 0.17 |