Experimental stannous fluoride toothpaste to improve gum health and reduce plaque.

A 24-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of an Experimental Stannous Fluoride Dentifrice in Improving Gingival Health and Reducing Plaque Accumulation

This 24-week test compares an experimental toothpaste containing 0.454% stannous fluoride to a regular fluoride toothpaste in adults with mild to moderate gingivitis to see if it improves gum health and reduces plaque.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Haleon (Industry-sponsored)
• Locations: 1 site (Fort Wayne, Indiana)
• Trial ID: NCT07255040 on ClinicalTrials.gov

What this trial studies

This single-center, randomized, single-blind (examiner only), parallel-group trial will enroll about 300 adults with clinically measurable mild to moderate gingivitis and randomize them to one of three dentifrice arms for 24 weeks. Participants will use the assigned toothpaste twice daily and return for scheduled visits where examiners will measure gingival health and plaque accumulation. The experimental dentifrice (0.454% w/w stannous fluoride) will be compared to a regular fluoride dentifrice as a negative control and a marketed 0.454% stannous fluoride dentifrice as a positive control. The design is stratified to balance groups and aims to obtain approximately 90 evaluable participants per group.

Who should consider this trial

Good fit: Adults aged 18 and older with clinically measurable mild to moderate gingivitis who can comply with twice-daily toothpaste use and scheduled clinic visits are the intended participants.

Not a fit: People without gingivitis, those with severe periodontal disease, recent major dental procedures, or known allergies to toothpaste ingredients may not receive benefit from this intervention.

Why it matters

Potential benefit: If effective, the experimental toothpaste could reduce gum inflammation and plaque buildup, helping lower the risk of worsening periodontal problems and improving daily oral health.

How similar studies have performed: Previous clinical research and several marketed stannous fluoride toothpastes have demonstrated reductions in plaque and gingivitis, so this approach has supporting evidence rather than being entirely novel.

Eligibility criteria

Inclusion Criteria:

* Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
* Participant is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive.
* A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
* A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant 's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.

Exclusion Criteria:

* A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
* A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
* A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
* A female participant who is a pregnant (self-reported) or intending to become pregnant over the duration of the study or who is breastfeeding.
* A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* A participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
* A participant who is a current smoker or an ex-smoker (including vaping) who stopped within 6 months of Screening or who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
* A participant who is diagnosed with xerostomia or is taking any medication that in the view of the investigator is causing xerostomia.
* A participant who has a medical condition which could have directly influenced gingival bleeding (example, type 2 diabetes) or who has a bleeding disorder that could have affected study outcomes and/or participant safety.
* A participant who has a recent history (within the last year) of alcohol or other substance abuse.
* A participant who has a severe oral condition (example, acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study.
* Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.
* Dental Exclusions:

  1. A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
  2. A participant who has dentures (partial or full).
  3. A participant who has fixed orthodontic appliances or is undergoing active or recent (within 3 months of Screening) orthodontic treatment, which in the opinion of the investigator, could interfere with study procedures, assessments or outcomes.
  4. A participant who has other orthodontic devices (example, bands, fixed retainers, or removable retainers) that could, in the opinion of the investigator, interfere with study procedures, assessment or outcomes.
  5. A participant who has numerous restorations in a poor state of repair.
  6. A participant who has any dental condition (example, overcrowding) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
  7. A participant who has had dental prophylaxis within 12 weeks of Screening.
  8. A participant who has had teeth bleaching within 12 weeks of Screening.
  9. A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could have interfered with plaque assessments.
* A participant who has previously been enrolled in this study.
* A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Where this trial is running

Fort Wayne, Indiana

• Salus Research, Inc. — Fort Wayne, Indiana, United States (Recruiting)

Study contacts

• Study coordinator: Haleon Response Center

Conditions Dental Plaque; Gingivitis