NCT07169188

A Clinical Study Investigating the Efficacy of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health

A 12-Week Randomized, Controlled, Single-Blind, Clinical Study Investigating the Efficacy of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2) to improve gingival health and reduce plaque accumulation compared to a regular fluoride toothpaste (reference dentifrice) in participants with localized, plaque-induced, gingivitis.

Detailed description

This will be a single-center, 12 weeks, randomized, controlled, examiner-blind, 2 treatment arms, parallel group design clinical study to evaluate the efficacy of an experimental toothpaste containing 0.454% SnF2, used twice daily in reducing gingivitis and plaque accumulation in a population with clinically measurable levels of gingivitis. The clinical efficacy of the experimental toothpaste will be compared with a reference dentifrice, a commercially available, regular fluoride toothpaste. Additionally, unstimulated saliva samples will be collected from a sub-set of the randomized participants pre-brushing and at 15, 30, 60 and 120 minutes post-brushing which will be analyzed for tin concentration to investigate the retention of the stannous \[tin (II)\] ion within the oral cavity. Approximately 160 participants will be randomized to ensure approximately 144 evaluable participants complete the study.

Conditions

• Dental Plaque
• Gingivitis

Interventions

Type	Name	Description
DRUG	Test Fluoride Toothpaste	Toothpaste containing 0.454% SnF2, 0.3% zinc chloride (ZnCl2) and 1% alumina.
DRUG	Colgate Cavity Protection Toothpaste	Regular fluoride toothpaste containing 0.76% sodium monofluorophosphate.

Timeline

• Start date: 2025-09-09
• Primary completion: 2025-12-23
• Completion: 2025-12-23
• First posted: 2025-09-11
• Last updated: 2026-01-21

Locations

1 site across 1 country: Canada