Dental Plaque, Gingival Inflammation and Bleeding
Conditions
Brief summary
Clinical study to evaluate and compare the efficacy of two baking soda containing dentifrices, containing 20% and 35% baking soda, to a non-baking soda dentifrice for their ability to reduce gingivitis and plaque following 6-months of use.
Interventions
DRUGDentifrices
Dentifrice on plaque, gingivitis, and bleeding.
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have provided written informed consent prior to being entered into the study. * Be between 18 and 70 years of age, male or female. * Have at least eighteen (18) natural teeth with scorable facial and lingual surfaces as determined by the Examiner. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, or third molars will not be included in the tooth count. * Have a mean baseline plaque index score ≥ 1.95 as determined by the Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (Pl). * Have a mean baseline gingival index score of ≥ l.70 and ≤ 3.0 as determined by the Modified Gingival Index (MGI). * Presence of ≥ 10 bleeding sites upon probing. * Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures any time during the study. * Agree to abstain from the use of chewing gum, mouth rinses, any toothpaste other than the study toothpaste, tooth whitening products (either professional or at home use) and all other oral hygiene other than the study procedures for the duration of the study. * Agree to refrain from all oral hygiene on the morning of each evaluation visit and to refrain from eating, drinking, and smoking for 4 hrs, prior to each evaluation visit. * Agree to comply with the conditions and schedule of the study.
Exclusion criteria
* Physical limitations or restrictions that might preclude normal tooth brushing. * Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, preexisting gross plaque or soft or hard tissue tumor of the oral cavity. * Heavy supra- or subgingival calculus that might interfere with evaluations as determined by the Investigator/Examiner. * Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner. * Conditions requiring antibiotic treatment prior to dental procedures. * History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable diseases, (e.g. cardiovascular disease, AIDS). * Subjects with grossly carious, fully crowned, or extensively restored teeth, orthodontic appliances, peri/oral piercings, or removable partial dentures. * Treatment with antibiotics within the 1-month period before the baseline examination, or a condition that is likely to require antibiotic treatment over the course of the trial. * Chronic treatment (2 weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, coumarin, nonsteroidal anti-inflammatory drugs, and aspirin) within 1 month of the baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment. * Have severe periodontal disease or being actively treated for periodontal disease. * Having history of early-onset periodontitis or acute necrotizing ulcerative gingivitis. * Concomitant periodontal therapy other than prophylaxis in the last 6 months. * Professional prophylaxis within 1 month prior to the baseline clinical evaluation. * Subjects who participated in a gingivitis study in the past month. * Daily use of chemotherapeutic antiplaque/antigingivitis products within the past 4 months. * History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. * Subjects who are allergic to any ingredients in the test or control product, as listed on the IRB Safety Assessment. * Self-reported pregnancy and nursing since hormonal changes can exaggerate gingival response to dental plaque.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | baseline, six weeks, 3 months and 6 months | Mean Within-Treatment Whole-Mouth Score as measured by Gingival Index (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: slight change in color, little change in texture to 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. The scale ranges from 0-4. |
| Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | baseline, six week, three months, and six months | Mean Within-Treatment Whole-Mouth Score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2. |
| Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | baseline, six weeks, three months, and six months | Mean Within-Treatment Whole-Mouth Score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown). The scale ranges from 0-5. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0% Baking Soda Dentifrice Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. | 103 |
| 20% Baking Soda Dentifrice Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. | 105 |
| 35% Baking Soda Dentifrice Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. | 107 |
| Total | 315 |
Baseline characteristics
| Characteristic | 0% Baking Soda Dentifrice | 20% Baking Soda Dentifrice | 35% Baking Soda Dentifrice | Total |
|---|---|---|---|---|
| Age, Continuous | 44.07 Age | 47.50 Age | 47.32 Age | 46.3 Age |
| Gingival Bleeding Efficacy | 0.165 units on a scale | 0.178 units on a scale | 0.189 units on a scale | 0.177 units on a scale |
| Gingvial Efficacy | 2.081 units on a scale | 2.094 units on a scale | 2.092 units on a scale | 2.089 units on a scale |
| Plaque Efficacy | 2.409 units on a scale | 2.411 units on a scale | 2.356 units on a scale | 2.4 units on a scale |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Canada | 103 participants | 105 participants | 107 participants | 315 participants |
| Sex: Female, Male Female | 75 Participants | 74 Participants | 80 Participants | 229 Participants |
| Sex: Female, Male Male | 28 Participants | 31 Participants | 27 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 105 | 0 / 107 |
| other Total, other adverse events | 4 / 103 | 17 / 105 | 2 / 107 |
| serious Total, serious adverse events | 0 / 103 | 0 / 105 | 0 / 107 |
Outcome results
Primary
Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy
Mean Within-Treatment Whole-Mouth Score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2.
Time frame: baseline, six week, three months, and six months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | Baseline | 0.165 units on a scale | Standard Deviation 0.085 |
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | 6 weeks | 0.149 units on a scale | Standard Deviation 0.091 |
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | 3 months | 0.141 units on a scale | Standard Deviation 0.088 |
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | 6 months | 0.129 units on a scale | Standard Deviation 0.082 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | 6 months | 0.096 units on a scale | Standard Deviation 0.104 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | Baseline | 0.178 units on a scale | Standard Deviation 0.129 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | 3 months | 0.116 units on a scale | Standard Deviation 0.117 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | 6 weeks | 0.135 units on a scale | Standard Deviation 0.122 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | 6 months | 0.069 units on a scale | Standard Deviation 0.053 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | 6 weeks | 0.122 units on a scale | Standard Deviation 0.081 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | 3 months | 0.094 units on a scale | Standard Deviation 0.067 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | Baseline | 0.189 units on a scale | Standard Deviation 0.114 |
Primary
Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy
Mean Within-Treatment Whole-Mouth Score as measured by Gingival Index (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: slight change in color, little change in texture to 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. The scale ranges from 0-4.
Time frame: baseline, six weeks, 3 months and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | Baseline | 2.081 units on a scale | Standard Deviation 0.096 |
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 6 weeks | 1.996 units on a scale | Standard Deviation 0.138 |
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 3 months | 1.980 units on a scale | Standard Deviation 0.155 |
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 6 months | 1.946 units on a scale | Standard Deviation 0.149 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 6 months | 1.763 units on a scale | Standard Deviation 0.209 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | Baseline | 2.094 units on a scale | Standard Deviation 0.117 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 3 months | 1.841 units on a scale | Standard Deviation 0.198 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 6 weeks | 1.919 units on a scale | Standard Deviation 0.171 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 6 months | 1.653 units on a scale | Standard Deviation 0.256 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 6 weeks | 1.882 units on a scale | Standard Deviation 0.174 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 3 months | 1.766 units on a scale | Standard Deviation 0.229 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | Baseline | 2.092 units on a scale | Standard Deviation 0.106 |
Primary
Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy
Mean Within-Treatment Whole-Mouth Score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown). The scale ranges from 0-5.
Time frame: baseline, six weeks, three months, and six months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | Baseline | 2.409 units on a scale | Standard Deviation 0.22 |
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | 6 weeks | 2.280 units on a scale | Standard Deviation 0.211 |
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | 3 months 3 months | 2.251 units on a scale | Standard Deviation 0.202 |
| 0% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | 6 months | 2.196 units on a scale | Standard Deviation 0.191 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | 6 months | 1.925 units on a scale | Standard Deviation 0.239 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | Baseline | 2.411 units on a scale | Standard Deviation 0.244 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | 3 months 3 months | 2.066 units on a scale | Standard Deviation 0.26 |
| 20% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | 6 weeks | 2.134 units on a scale | Standard Deviation 0.259 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | 6 months | 1.793 units on a scale | Standard Deviation 0.287 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | 6 weeks | 2.026 units on a scale | Standard Deviation 0.227 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | 3 months 3 months | 1.907 units on a scale | Standard Deviation 0.265 |
| 35% Baking Soda Dentifrice | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | Baseline | 2.356 units on a scale | Standard Deviation 0.24 |