Actively Recruiting
A 24-Week Randomized Controlled Study Evaluating an Experimental Stannous Fluoride Toothpaste for Improving Gum Health and Reducing Plaque
Led by HALEON · Updated on 2025-12-19
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental toothpaste containing 0.454% stannous fluoride (SnF2) to see if it can improve gum health and reduce plaque better than a regular fluoride toothpaste in adults with mild to moderate gingivitis. This 24-week, randomized, controlled, examiner-blind study includes about 300 participants divided into three groups to compare the experimental toothpaste with a marketed SnF2 toothpaste and a regular fluoride toothpaste. Participants will brush their teeth twice daily for at least one minute using either the experimental dentifrice, a marketed dentifrice with SnF2, or a regular fluoride dentifrice. Each treatment lasts for 24 weeks, with the goal of assessing differences in gingival health and plaque accumulation across the three groups. During the study, participants will be regularly evaluated for gingival bleeding and plaque levels at weeks 1, 4, 12, and 24 using standardized indices. Researchers will monitor gum health and plaque reduction to measure the toothpaste effectiveness. The primary outcome is the number of bleeding sites at week 24, and safety and adherence will be observed throughout the trial.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Effectiveness of an Experimental Toothpaste in Improving Gum Health and Reducing Plaque Accumulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study assessments
- Adults aged 18 years or older of any gender
- Willing and able to follow study visits and procedures
- In good general and mental health without medical or oral conditions that could affect safety or study outcomes
You will not qualify if you...
- Employees of the study site or Haleon involved in the study and their immediate family members
- Participation in other investigational studies within 30 days before or during this study
- Acute or chronic medical, psychiatric, or laboratory conditions that increase risk or interfere with study
- Pregnant or breastfeeding women, or those intending pregnancy during the study
- Known intolerance or allergy to study materials
- Unwilling or unable to follow lifestyle restrictions in the protocol
- Current smokers or recent ex-smokers (within 6 months), or users of smokeless tobacco
- Diagnosis of dry mouth or medications causing dry mouth
- Medical conditions affecting gum bleeding or bleeding disorders
- Recent history of alcohol or substance abuse
- Severe oral conditions that could affect study outcomes
- Oral piercings interfering with toothbrush use
- Active dental caries or dentures
- Fixed orthodontic appliances, recent orthodontic treatment, or orthodontic devices interfering with assessments
- Poorly repaired dental restorations
- Dental conditions like overcrowding affecting outcomes
- Dental cleaning or teeth bleaching within 12 weeks before screening
- High levels of extrinsic stain or calculus deposits
- Previous enrollment in this study
- Investigator's judgment deeming participation inappropriate or unsafe
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants use assigned toothpaste twice daily for 24 weeks to improve gum health and reduce plaque accumulation.
Visits at Weeks 1, 4, 12, and 24 for assessments
Trial Site Locations
Total: 1 location
1
Salus Research, Inc.
Fort Wayne, Indiana, United States, 46825
Actively Recruiting
Research Team
H
Haleon Response Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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