NCT06048809

A Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome

A Randomised, Controlled, Examiner Blind, Methodology Development Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the effect of a toothpaste containing stannous fluoride (SnF2) over time on the oral bacterial composition and activity and to explore its effect in comparison to a regular fluoride toothpaste.

Detailed description

This will be a single-center, 6-week, randomized, controlled, analyst and examiner-blind, two treatment, parallel group design, methodology development clinical study, investigating the efficacy of a toothpaste containing 0.454 percent (%) SnF2 in healthy adult participants with mild-moderate gingivitis. The study will describe and compare the overall oral bacterial composition and activity following 6 weeks use of a 0.454 % SnF2 toothpaste and regular fluoride toothpaste (control) using microbial and functional profiling techniques. Participants will be instructed to brush twice daily (morning and evening) in their usual manner, for 1-timed minute, for 6 weeks and to record each brushing in the diary provided. Sufficient participants will be screened to ensure approximately 50 participants complete the entire study.

Conditions

• Oral Health

Interventions

Type	Name	Description
OTHER	Stannous Fluoride Toothpaste (Sensodyne Repair and Protect)	Sensodyne Repair and Protect toothpaste containing 1100 ppm fluoride as SnF2.
OTHER	Regular Fluoride Toothpaste (Colgate Cavity Protection)	Colgate Cavity Protection containing 1100 ppm fluoride as SMFP.

Timeline

• Start date: 2024-04-10
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2023-09-21
• Last updated: 2025-07-10
• Results posted: 2025-07-10

Locations

1 site across 1 country: United States