Stannous Fluoride Toothpaste for Reduction and Treatment of Gingivitis

• Sodium Fluoride Dentifrice (Drug): Comparator toothpaste
• Stannous Fluoride Toothpaste (SnF) (Drug): Test toothpaste (0.454% SnF)

Primary outcomes

• Evaluate the efficacy of a stannous fluoride toothpaste in gingival inflammation [12 weeks]: Change from baseline in whole-mouth Modified Gingival Index (MGI) score at Week 12 Whole-mouth gingival inflammation will be assessed using the Modified Gingival Index (MGI). Scores are recorded on scorable gingival areas of all scorable teeth using a 0-4 scale, and the whole-mouth MGI score is calculated as the sum of all site scores divided by the number of scorable sites examined. The primary analysis compares the change from baseline to Week 12 between treatment groups.

Secondary outcomes

• Evaluate improvements at weeks 2, 4, 8; assess gingival bleeding at weeks 2, 4, 8, and 12 weeks [2, 4, 8, and 12 weeks]: Secondary outcome measures include change from baseline in whole-mouth bleeding index at Weeks 2, 4, 8, and 12...based on scorable gingival areas using the Saxton 0-2 scale
• Evaluate improvements at weeks 2, 4, 8; assess plaque control at weeks 2, 4, 8, and 12 weeks [2, 4, 8, and 12 weeks]: Secondary outcome measures include change from baseline in plaque at Weeks 2, 4, 8, and 12...calculated from disclosed plaque scores on scorable buccal and lingual tooth surfaces using the Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index; lower scores indicate improvement for all measures.
• Evaluate improvements at weeks 2, 4, 8; in whole mouth Modified Gingival Index (MGI) scores [2, 4, and 8 weeks]: Secondary outcome measures include change from baseline in whole-mouth MGI at Weeks 2, 4, and 8, using the Modified Gingival Index (MGI). Scores are recorded on scorable gingival areas of all scorable teeth using a 0-4 scale, and the whole-mouth MGI score is calculated as the sum of all site scores divided by the number of scorable sites examined.

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Male or female subjects aged 18 to 65 years (inclusive)
* Provided written informed consent prior to participation
* Able to brush their own teeth on a daily basis
* In good general health based on medical history review
* Minimum of at least 18 natural, scorable teeth
* Mean plaque index score ≥ 1.95
* Mean baseline gingival index score ≥ 1.70 and ≤ 3.0
* Agreed to refrain from use of all oral hygiene products other than those supplied for the study
* Agreed to refrain from oral hygiene, eating, drinking, and chewing gum for approximately 12 hours prior to study visits
* Agreed not to undergo dental prophylaxis or elective dental procedures during the study
* Willing and able to comply with study procedures and visit schedule

Exclusion Criteria:

* Physical limitations or restrictions that preclude normal tooth brushing
* Requirement for premedication prior to dental treatment
* Pregnancy or intent to become pregnant during the study period
* Use of tobacco or nicotine products
* Poor oral hygiene defined as >40 bleeding sites
* Presence of dental caries or calculus deposits that may interfere with plaque assessments
* Major oral hard or soft tissue lesions or trauma at baseline
* Presence of fixed or removable orthodontic appliances
* Dental prophylaxis within 1 month prior to baseline visit
* History of significant adverse events, allergy, or irritation related to oral hygiene products

• Annahita Ghassemi, Study director, Church & Dwight, Inc.