NCT06660069

A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation

A 12-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the ability of a marketed Cetylpyridinium Chloride (CPC) mouthwash alongside a marketed Stannous Fluoride (SnF2) toothpaste in improving gingival health and reducing plaque accumulation, compared to the use of a regular fluoride toothpaste alone in participants with clinically measurable plaque-induced gingivitis.

Detailed description

This will be a single center, 12-week, randomized, controlled, examiner-blind, 3-treatment arm, parallel group, stratified (by sex \[male/female\]) study to evaluate the efficacy of using the SnF2 toothpaste/CPC mouthwash twice daily in reducing gingivitis and plaque accumulation in a population with clinically measurable levels of gingivitis. The clinical efficacy of the commercially available SnF2 toothpaste/CPC mouthwash will be compared with that of a commercially available, regular fluoride toothpaste with no known anti-gingivitis nor anti-plaque efficacy properties (negative control). This study will also explore whether a CPC mouthwash used with a SnF2 toothpaste could provide benefits in plaque accumulation reduction and gingival health improvement over the sole use of SnF2 toothpaste (reference product). Sufficient participants will be screened to randomize approximately 198 participants (approximately 66 per group) to ensure approximately 180 evaluable participants (approximately 60 per group) complete the study.

Conditions

• Dental Plaque
• Gingivitis

Interventions

Type	Name	Description
DRUG	Stannous Fluoride Toothpaste (Parodontax Complete Protection Toothpaste)	Toothpaste containing 0.454 percent (%) weight by weight (w/w) SnF2.
DRUG	CPC Mouthwash (Parodontax Active Gum Health Mouthwash)	Mouthwash containing 0.07% w/w CPC.
DRUG	Regular Fluoride Toothpaste (Crest Cavity Protection)	Toothpaste containing 0.243% w/w sodium fluoride.
DRUG	Stannous Fluoride Toothpaste (Parodontax Complete Protection Toothpaste)	Toothpaste containing 0.454% w/w SnF2.

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-03-11
• Completion: 2025-03-11
• First posted: 2024-10-26
• Last updated: 2026-03-18
• Results posted: 2026-03-18

Locations

1 site across 1 country: United States