Stannous Fluoride Toothpaste for Reduction and Treatment of Gingivitis

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