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.