Gingivitis, Periodontitis
Conditions
Keywords
Gingivitis or periodontitis (Stage I or II)
Brief summary
90-day, self-controlled, longitudinal, non-blinded clinical trial which will measure changes in clinical parameters in participants with gingivitis and Stage I or II periodontitis who apply ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse.
Detailed description
The study will be conducted with 60 medically healthy participants between ages 18 to 75 years with gingival or periodontitis (Stage I or II) who are receiving routine preventive care and/or periodontal maintenance. Subjects will brush with ClōSYS® Sensitive Fluoride Toothpaste twice daily and rinse with ClōSYS® Sensitive Rinse twice daily after brushing. The primary response variables will be the Subjects' scores on the Plaque Index (PI), Gingival Index (GI) and the number of sites with bleeding upon probing (BOP). Probing depths and clinical attachment level will be assessed at baseline and 3 months. Adverse events will also be assessed and documented at each visit. In addition, Subjects will keep a usage diary documenting their daily use of the toothpaste and oral rinse and any comments or observations regarding usage or adverse events.
Interventions
DRUGClōSYS® Sensitive Fluoride Toothpaste
ClōSYS® Sensitive Fluoride Toothpaste is an over-the-counter drug product containing 0.12% stabilized chlorine dioxide (sodium chlorite in an aqueous solution) and 0.13% w/v fluoride ion.
OTHERClōSYS® Sensitive Rinse
ClōSYS® Sensitive Rinse is a cosmetic product containing 0.1% stabilized chlorine dioxide.
Sponsors
Rowpar Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects are between the ages of 18 to 80 years * Subjects have a minimum of 20 permanent teeth, excluding third molars * Subjects have been diagnosed with gingivitis or periodontitis (Stages I and II are based on the level of CAL and Bone Loss (BL). The diagnosis is Stage I if: (a) BL is less than 15% and (b) CAL is between 1-2mm. The diagnosis is Stage II if: (a) BL is between 15% and 33% and (b) CAL is between 3-4mm) * Subjects exhibit bleeding upon probing in \>20% of sites * Subject is seen every 3 months for routine dental prophylaxis/periodontal maintenance * Subjects do not have a significant medical history or metabolic diseases (diabetes with A1C ≥ 7.0, pregnancy) * Subject is currently a non-smoker or has discontinued smoking at least 6 months prior to enrollment * Subject agrees to refrain from use of the following products: Peridex®, PerioGuard®, Listerine®, Cepacol®, Crest Pro-Health® rinse, Colgate Total® rinse, Colgate Total® toothpaste, Crest Pro Health® toothpaste, or any generic equivalent while participating in this study. Alcohol is not the active ingredient in any oral rinse product and does not produce a significant antibacterial effect * Subject is able to read and provide written informed consent * Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations * Subject agrees not to receive a dental cleaning (prophylaxis) while in the study * Subject must permanently reside in Arizona
Exclusion criteria
* Subject has significant medical history or poorly controlled/uncontrolled diabetes (as defined above) * Subject is pregnant * Subject has a medical condition that requires antibiotic premedication prior to dental treatment * Subject has taken antibiotics within 1 month of study enrollment * Subject who takes multiple medications and/or herbal and dietary supplements known to alter bleeding and exhibits/reports spontaneous gingival bleeding * Subject takes medications that may interfere with study results (eg. antibiotics, steroids, immunosuppressants, high dose aspirin (325+ mg/day), chemotherapy and/or radiation therapy for cancer). * Subject is a current smoker * Subject has a history of non-surgical or surgical periodontal therapy within 6 months of study participation * Subject has Stage III or IV periodontitis, Grade B or C * Subject is currently taking or in the past 28 days has taken another investigational drug or participated in other investigational studies that may impact study outcomes * Subject has not had a dental cleaning within six months prior to the start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Modified Gingival Index (MGI) | Baseline and 12 weeks | MGI uses a rating score between 0 and 4, with 0 indicating a tooth with healthy gums and 4 the most severe inflammation. MGI scores were determined by visual exam of the gingiva on 4 surfaces for each tooth present except for third molars, for a total of 28 teeth. The total number of teeth exhibiting inflammation affecting all portions of the gingival unit (Score ≥ 2) were noted at each visit. The total number of teeth affected was evaluated for each visit in the final analysis. At baseline: Score range is (0-64) At 12 weeks: Score range is (0-32) |
| Changes in Plaque Index (PI) | Baseline and 12 weeks | The PI was recorded on all teeth except for third molars. PI was recorded on 4 surfaces of each tooth. PI uses a rating score between 0 and 3, with 0 indicating no plaque in gingival area and 3 heavy accumulation of plaque. Total score is reported. At baseline: Score range is 9 -157. At 12 weeks: Score range is 1 -147. |
| Changes in Bleeding On Probing (BOP) | Baseline and 12 weeks | Bleeding On Probing (BOP) will be recorded as a dichotomous variable (present/absent) during the periodontal examination. The percentage of sites that bleed will be calculated by dividing the number of sites with bleeding by the total number of sites. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 90 Days | Adverse events will be collected throughout the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Participants with gingivitis or periodontitis (Stage I or II) brush with ClōSYS® Sensitive Fluoride Toothpaste twice daily and rinse with ClōSYS® Sensitive Rinse twice daily after brushing. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 8.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 56 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Changes in Bleeding On Probing (BOP)
Bleeding On Probing (BOP) will be recorded as a dichotomous variable (present/absent) during the periodontal examination. The percentage of sites that bleed will be calculated by dividing the number of sites with bleeding by the total number of sites.
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Changes in Bleeding On Probing (BOP) | Baseline | 37.0 percentage of sites with bleeding |
| Treatment Group | Changes in Bleeding On Probing (BOP) | 12 weeks | 15.0 percentage of sites with bleeding |
p-value: <0.001Wilcoxon signed rank test
Primary
Changes in Modified Gingival Index (MGI)
MGI uses a rating score between 0 and 4, with 0 indicating a tooth with healthy gums and 4 the most severe inflammation. MGI scores were determined by visual exam of the gingiva on 4 surfaces for each tooth present except for third molars, for a total of 28 teeth. The total number of teeth exhibiting inflammation affecting all portions of the gingival unit (Score ≥ 2) were noted at each visit. The total number of teeth affected was evaluated for each visit in the final analysis. At baseline: Score range is (0-64) At 12 weeks: Score range is (0-32)
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Changes in Modified Gingival Index (MGI) | Baseline | 8.5 score on a scale |
| Treatment Group | Changes in Modified Gingival Index (MGI) | 12 weeks | 1.5 score on a scale |
p-value: <0.001Kruskal-Wallis
Primary
Changes in Plaque Index (PI)
The PI was recorded on all teeth except for third molars. PI was recorded on 4 surfaces of each tooth. PI uses a rating score between 0 and 3, with 0 indicating no plaque in gingival area and 3 heavy accumulation of plaque. Total score is reported. At baseline: Score range is 9 -157. At 12 weeks: Score range is 1 -147.
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Changes in Plaque Index (PI) | Baseline | 22.0 score on a scale |
| Treatment Group | Changes in Plaque Index (PI) | 12 weeks | 8.0 score on a scale |
p-value: <0.001Kruskal-Wallis
Secondary
Adverse Events
Adverse events will be collected throughout the study
Time frame: 90 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Adverse Events | 0 participants |