Efficacy of a mouthrinse containing 0.05% cetylpyridinium chloride for the control of plaque and gingivitis: a 6-month clinical study in adults.

The objective of this 6-month, double-blind, clinical study, conducted following the American Dental Association (ADA) guidelines, was to provide an assessment of the effectiveness of a newly developed mouthrinse containing 0.05% cetylpyridinium chloride (CPC) for the control of supragingival dental plaque and gingivitis. Adult men and women from the Manchester, England, area were entered in the study, and stratified into two treatment groups (CPC mouthrinse and control mouthrinse), which were balanced for baseline Quigley-Hein Plaque Index scores and baseline Löe-Silness Gingival Index scores. Participants were given an oral prophylaxis and instructed to brush their teeth twice daily (morning and evening) for 1 minute with a soft-bristled toothbrush and fluoride dentifrice provided, immediately followed by rinsing for 30 seconds with 15 cc of their assigned mouthrinse. Examinations for supragingival plaque and gingivitis were conducted after 3 months' and again after 6 months' participation in the study. One hundred eleven participants complied with the protocol and completed the entire 6-month clinical study. At both the 3- and 6-month study examinations, the CPC mouthrinse group exhibited statistically significantly less supragingival plaque and gingivitis than did the control mouthrinse group. At the 6-month examination, the magnitude of these differences met or exceeded 24% for all 4 parameters measured (28.2% for Quigley-Hein Plaque Index, 63.4% for Plaque Severity Index, 24.0% for Löe-Silness Gingival Index, and 66.9% for Gingivitis Severity Index). The magnitude of the reductions in supragingival plaque and gingivitis were adequately large to support a claim of efficacy, in accordance with the criteria provided by the published guidelines of the ADA for the demonstration of the efficacy of a chemotherapeutic agent for the control of supragingival plaque and gingivitis. Thus, the results of this 6-month clinical study support the conclusion that a newly developed mouthrinse containing 0.05% cetylpyridinium chloride provides a statistically significant, clinically relevant level of efficacy for the control of supragingival plaque, and for the control of gingivitis, in accordance with the criteria provided by current ADA guidelines.

RCT Entities:   Population Interventions Outcomes