Clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride in reducing dental plaque.
OBJECTIVE
The objective of this independent, double-blind, seven-day clinical study was to assess the efficacy of a commercially available mouthrinse containing 0.05% CPC for controlling dental plaque relative to that of a control mouthrinse without 0.05% CPC.


METHODS
Adult male and female subjects from the San Juan, Puerto Rico area reported to the clinical facility, having refrained from any oral hygiene procedures for 12 hours, and from eating, drinking, and smoking for four hours, for an assessment of the oral soft and hard tissues and a baseline dental plaque evaluation. Qualifying subjects were randomly assigned into one of the two treatment groups, and were provided with their assigned mouthrinse, an adult soft-bristled toothbrush, and a commercially available fluoride toothpaste for home use. Over the seven-day period of home use, during which there were no restrictions regarding diet or smoking habits, subjects were instructed to brush their teeth for one minute twice daily (morning and evening) with the toothbrush and toothpaste supplied, to rinse their mouths with water after brushing, and then to rinse with 15 ml of their assigned mouthrinse for one minute before expectorating. The use of other oral hygiene products or procedures, such as floss or interdental stimulators, was not permitted during the study. After seven days of product use, subjects returned to the clinical facility having followed the same restrictions with respect to oral hygiene procedures, eating, and drinking as prior to the baseline examination, and the oral soft and hard tissue assessments and dental plaque evaluations were repeated. Comparisons between treatment groups with respect to baseline-adjusted Plaque Index scores at the seven-day examination were performed using Analyses of Covariance, p < or = 0.05.


RESULTS
Forty-eight subjects complied with the protocol and completed the study. Results demonstrated that, after seven days of product use and 12 hours after rinsing, both the CPC mouthrinse group and the control mouthrinse group exhibited statistically significant reductions in whole-mouth Plaque Index scores (25.3% and 6.6%, respectively), in Plaque Index scores measured at interproximal sites (51.3% and 32.9%, respectively), and in Plaque Severity Index scores (43.5% and 25.4%, respectively). Relative to the control mouthrinse, the 0.05% CPC mouthrinse group exhibited statistically significant greater reductions in whole-mouth plaque scores (15.9%), in Plaque Index scores measured at interproximal sites (23%), and in Plaque Severity Index scores (17%). As the measurements were made 12 hours after final product use, the results also demonstrate that the CPC mouthrinse provides 12-hour protection against plaque accumulation in individuals with existing plaque.


CONCLUSIONS
The overall results of this double-blind clinical study support the conclusion that after seven days of product use, a mouthrinse containing 0.05% CPC provides significantly greater efficacy for reducing dental plaque 12 hours after use, than does a control mouthrinse without 0.05% CPC.
Hernandez-Cott
Pedro L
PL
University of Puerto Rico School of Dental Medicine, San Juan, Puerto Rico.
Elias Boneta
Augusto
A
Stewart
Bernal
B
DeVizio
William
W
Proskin
Howard M
HM
D000328:Adult; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D002594:Cetylpyridinium / Q000627:therapeutic use*; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use*; D055815:Young Adult
D000891:Anti-Infective Agents, Local; D009067:Mouthwashes; D002594:Cetylpyridinium