drugset / Trial / 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

NCT06660069 ↗

Completed 199 enrolled HALEON
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2024-11-18
Primary completion
2025-03-11
Completion
2025-03-11

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash): 10.1 (Standard Error 1.03) bleeding sites NCT06660069 ↗

registry LEAST_SQUARES_MEAN Negative Control Toothpaste (Sodium Fluoride Toothpaste): 24.1 (Standard Error 1.05) bleeding sites NCT06660069 ↗

registry analysis (superiority test); Toothpaste/Mouthwash (SnF2 Toothpaste Followed by CPC Mouthwash) vs Negative Control Toothpaste (Sodium Fluoride Toothpaste); p <0.0001 NCT06660069 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetylpyridinium Small molecule 0.07 % Oral
Comparator sodium fluoride Unknown 0.243 % Oral
Comparator stannous fluoride Small molecule 0.454 % Oral