A Study to Evaluate the Effect of a Test (Sodium Bicarbonate) Toothpaste on the Oral Microbiome
brief summary
The aim of this 12-week clinical study is to evaluate the effect of a toothpaste containing sodium bicarbonate over time on the oral microbiome and to explore its effect in comparison to a regular fluoride toothpaste in participants with localized gingivitis.
detailed description
This will be a single-center, 12-week, randomized, controlled, single-blind (examiner only), two-treatment arm, parallel group design, clinical study investigating the effect of a toothpaste containing sodium bicarbonate on the oral microbiome in healthy adult participants with mild-moderate gingivitis. Approximately 55 participants (approximately 27 per group) will be randomized to ensure approximately 50 evaluable participants (approximately 25 per group) complete the study.
official title
A Randomised, Controlled, Examiner Blind Study to Evaluate the Effect of a Sodium Bicarbonate Toothpaste on the Oral Microbiome