2-Month Plaque Prevention Clinical Trial with 0.1% Cetylpryidinium Chloride Rinse

Objective: This randomized controlled trial evaluated post-prophylaxis plaque accumulation with a 0.1% cetylpryidinium chloride mouthrinse.  Methods: Following IRB review, informed consent was obtained, and healthy adult volunteers with overnight plaque were provided a manual brush and anticavity paste for acclimation.  After acclimation, a dental prophylaxis was administered, and balancing for baseline plaque, subjects were randomly assigned a 0.1% cetylpryidinium chloride rinse (Crest® Pro-Health Clinical) or routine hygiene (control).  Treatment was at-home and unsupervised, and overnight plaque accumulation was evaluated after 1 day, 2 weeks and 2 months.  For measurement, subjects rinsed with a fluorescein dye, high resolution intraoral digital images were collected, and plaque surface area was measured objectively via image analysis as area (%) coverage.  Results: A total of 34 subjects were treated, mean (SD) age was 42.3 (17.1) years, ranging from 22-76 years, and 29 subjects (15 rinse & 14 control) completed the 2-month study.  The population exhibited appreciable overnight plaque with mean (SD) overnight plaque area% of 24.3 (12.7).  Relative to baseline, the oral hygiene group exhibited significant (p<0.05) reductions in overnight plaque only at the Day 1 post-prophylaxis visit, returning quickly to pre-prophylaxis level, while in contrast, the rinse group exhibited significant reductions throughout.   ANCOVA mean plaque area% was 8.7, 19.2 and 18.6 for the control at Days 1, Week 2 and Month 2 respectively compared to 5.5, 6.4 and 9.1 in the rinse group.  Treatments differed significantly (p<0.003) at Day 1, and throughout the trial.  One subject (rinse) withdrew due to an adverse event.  Conclusion: Use of a 0.1% cetylpyridinium chloride rinse significantly limited plaque accumulation beginning the first day after prophylaxis, with less than one-half the overnight plaque accumulation seen with routine hygiene two months after prophylaxis.  This study was sponsored by Procter & Gamble Co.