NCT07640399CompletedNot Applicable
Efficacy of a Stannous Fluoride Toothpaste in the Reduction and Treatment of Gingivitis: A Randomized Controlled Trial
Church & Dwight Company, Inc.1 site in 1 country133 target enrollmentStarted: March 17, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 133
- Locations
- 1
Study Overview
Brief Summary
This study evaluated the efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste in reducing gingivitis, bleeding, and plaque over a 12-week period.
A total of 132 subjects were randomized to one of two treatment groups and assessed at baseline and at Weeks 2, 4, 8, and 12 using standardized clinical indices, including the Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Investigators
Study Sites (1)
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