NCT07273539

A Study to Evaluate the Effect of a Test (Sodium Bicarbonate) Toothpaste on the Oral Microbiome

A Randomised, Controlled, Examiner Blind Study to Evaluate the Effect of a Sodium Bicarbonate Toothpaste on the Oral Microbiome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	Sodium Bicarbonate Toothpaste	A toothpaste containing sodium bicarbonate and sodium fluoride.
DRUG	Sodium Fluoride Toothpaste	A toothpaste containing 0.315 percent (%) weight/weight (w/w) sodium fluoride; 1450 parts per million (ppm) fluoride.

Timeline

• Start date: 2025-10-27
• Primary completion: 2026-02-27
• Completion: 2026-02-27
• First posted: 2025-12-09
• Last updated: 2026-03-11

Locations

1 site across 1 country: United Kingdom