Oral Health Clinical Trial
Official title:
A Randomised, Controlled, Examiner Blind, Methodology Development Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome
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.
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. ;
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