NCT07255040

A Clinical Study to Evaluate the Effectiveness of an Experimental Toothpaste in Improving Gum Health and Reducing Plaque Accumulation

A 24-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of an Experimental Stannous Fluoride Dentifrice in Improving Gingival Health and Reducing Plaque Accumulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this 24-week clinical study is to evaluate the ability of an experimental dentifrice containing 0.454 percent (%) weight by weight (w/w) Stannous fluoride (SnF2); to improve gingival health, plaque reduction and prevention of plaque accumulation compared with a regular fluoride dentifrice (negative control) in participants with mild to moderate gingivitis.

Detailed description

This will be a single-center, 24-week, randomized, controlled, single blind (examiner only), 3-treatment arms, parallel group, stratified study, to evaluate the efficacy of using an experimental dentifrice containing 0.454% w/w Stannous fluoride, twice daily in reducing gingivitis and plaque accumulation in a population with clinically measurable level of gingivitis. The clinical efficacy of the experimental dentifrice will be compared to a commercially available regular fluoride dentifrice as negative control. In addition, a marketed dentifrice containing 0.454% w/w SnF2 is included as positive control to provide a well-established benchmark. Approximately 300 participants (approximately 100 per group) will be randomized to ensure approximately 270 evaluable participants (approximately 90 per group) complete the study.

Conditions

• Dental Plaque
• Gingivitis

Interventions

Type	Name	Description
DRUG	Test Dentifrice	Experimental dentifrice containing 0.454% w/w SnF2.
DRUG	Parodontax Complete Protection	Marketed dentifrice containing 0.454% w/w SnF2.
DRUG	Colgate Cavity Protection	Marketed regular fluoride dentifrice.

Timeline

• Start date: 2025-11-19
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-11-28
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States