119 2-Month Plaque Prevention Clinical Trial with 0.1% Cetylpryidinium Chloride Rinse

Thursday, March 22, 2012: 8 a.m. - 9:30 a.m.
Presentation Type: Oral Session
M.L. SINGH1, A. PAPAS2, S. SUNDARALINGAM2, E. TZAVARAS2, R. CHENG3, J. WITT3, and R. GERLACH3, 1Public Health and Community Service, Tufts University, Boston, MA, 2Oral Medicine, Tufts University, Boston, MA, 3Health Care Research Center, Procter & Gamble Company, Mason, OH
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.
This abstract is based on research that was funded entirely or partially by an outside source: Proctor & Gamble Co

Keywords: 0.1% Cetylpryidinium, Clinical trials, Digital image analysis and Plaque
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