NCT06933368

A Clinical Study to Evaluate the Efficacy of a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this 12-week clinical study is to evaluate the ability of an experimental mouthwash, containing 0.085 percent (%) Cetylpyridinium chloride (CPC) as an adjunct to toothbrushing with a regular fluoride toothpaste, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste alone in participants with plaque-induced mild to moderate gingivitis.

Detailed description

This will be a single-center, 12-week, randomized, controlled, single blind (examiner only), 2-treatment arms, parallel group, stratified (by sex \[male/female\]) study, investigating gingival health and subgingival plaque reduction on healthy participants after twice daily using of an experimental mouthwash containing 0.085% weight/weight (w/w) CPC in combination with a commercially available regular toothpaste containing 0.243% w/w Sodium Fluoride (NaF) compared to a commercially available regular toothpaste containing 0.243% w/w NaF with no known anti-gingivitis nor anti plaque efficacy properties as control group. Approximately 132 participants (approximately 66 per group) will be randomized to ensure approximately 120 evaluable participants (approximately 60 per group) complete the study.

Conditions

• Dental Plaque
• Gingivitis

Interventions

Type	Name	Description
DRUG	Crest Cavity Protection Toothpaste	Toothpaste containing 0.243% w/w NaF.
DRUG	Experimental Mouthwash	Mouthwash containing 0.085% w/w CPC.

Timeline

• Start date: 2025-04-21
• Primary completion: 2025-08-14
• Completion: 2025-08-14
• First posted: 2025-04-18
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States