NCT06602466

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

A 4-Week Randomised, Controlled, Examiner-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: 175 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% Zinc Chloride (ZnCl2) and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in participants with plaque-induced mild to moderate gingivitis.

Detailed description

This will be a single-center, 4 weeks, randomized, controlled, examiner-blind, 2 treatment arms, stratified, parallel group design clinical study, investigating gingival health and supra-gingival plaque reduction on healthy participants after using an experimental toothpaste containing 0.454% SnF2, 0.3% ZnCl2 and 1% Alumina. Sufficient participants will be screened so that at least 160 participants are randomized (approximately 80 per group) to ensure approximately 144 (approximately 72 per group) evaluable participants complete the entire study.

Conditions

• Dental Plaque
• Gingivitis

Interventions

Type	Name	Description
DRUG	Test toothpaste	0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina toothpaste containing 1100 parts per million (ppm) fluoride.
DRUG	Colgate Cavity Protection Toothpaste	Commercial toothpaste containing 1450 ppm fluoride.

Timeline

• Start date: 2024-09-23
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2024-09-19
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

1 site across 1 country: United Kingdom