Stannous Fluoride and Gingivitis

Study Overview
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Brief Summary
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8-week study using stannous fluoride toothpaste on subjects with gingivitis (unhealthy) and without gingivitis (healthy). Gingivitis index will be performed at BL, Week 4 and Week 8. A number of biological samples will be collected at each timepoint.

Official Title
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A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: Stannous fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18 years of age or older; Provide written informed consent and receive a signed copy of consent; Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study; Agree not to participate in any other oral care studies for the duration of this study; Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products; Agree to return for all scheduled visits and follow study procedures; Have at least 16 natural teeth; Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study. For Unhealthy Group: Have at least 20 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and Have a minimum of 3 sampling sites with bleeding and pocket depth >/=3mm but not deeper than 4mm at the Screening visit. For Healthy Group: Have a maximum of 3 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and No pockets deeper than 2mm. Exclusion Criteria: Self-reported pregnancy or the intent to become pregnant anytime during the course of the study; Inability to comply with study procedures; Rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment; Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession; Fixed orthodontic appliances or attachments for aligner treatment; Having had a dental prophylaxis within 2 weeks of plaque sampling visits; Having taken antibiotics or used anti-gingivitis/anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits; Needing an antibiotic prophylaxis prior to dental visits; Presenting with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or Having any condition or disease, as determined by the Investigator/Designee which could be expected to interfere with examination procedures or with the subject's safe completion of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Group<br>Subjects without gingivitis (</= 3 bleeding sites) will use stannous fluoride toothpaste | Drug: Stannous fluoride<br>* brush twice daily with stannous fluoride toothpaste for 8 weeks<br>|
| Active Comparator: Unhealthy Group<br>Subjects with gingivitis (>/= bleeding 20 sites) will use stannous fluoride toothpaste | Drug: Stannous fluoride<br>* brush twice daily with stannous fluoride toothpaste for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MGI | Modified Gingival Index- validated assessment of gingival health looking at inflammation based on 4-point range 0 (normal gingiva) to 4 (severe inflammation). | 8 weeks | 
| GBI | Gingival Bleeding Index- validated assessment of gingival health looking at bleeding based on 2-point range 0 (Absence of bleeding) to 2 (Immediate bleeding) | 8 weeks |