Objective: The objective of this independent, double-blind, parallel, six-week clinical study was to assess the efficacy of a commercially available mouthrinse containing 0.05% cetylpyridinium chloride (CPC) for controlling established dental plaque and gingivitis relative to that of a control mouthrinse without CPC.
Methods: Adult male and female subjects from the Maceió, Brazil area reported to the clinical facility, after 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 for a baseline gingivitis and dental plaque evaluation. Qualifying subjects were randomly assigned to one of the two treatment groups, and were provided with their assigned mouthrinse, and an adult soft-bristled toothbrush and toothpaste for home use. Over the six-week 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 with the supplied toothbrush and a commercially available fluoride toothpaste, to rinse their mouths with water after brushing, and then to rinse with their assigned mouthrinse for one minute before expectorating. The use of any other oral hygiene products or procedures, such as floss or interdental stimulators, was not permitted during the study. After six weeks of product use, subjects returned to the clinical facility, having followed the same restrictions with respect to oral-hygiene procedures, eating and drinking, as with the baseline visit, and the oral soft and hard tissue assessments and gingivitis and dental plaque evaluations were repeated.
Results: One-hundred and ten subjects complied with the protocol and completed the study. With regard to supragingival plaque, after six weeks of product use, the subjects using the 0.05% CPC mouthrinse exhibited statistically significant reductions from baseline in whole-mouth Plaque Index scores (32.1%), in Plaque Index scores measured at interproximal sites (31.3%), and in Plaque Severity Index scores (84.8%). Subjects using the control mouthrinse exhibited statistically significant reductions from baseline in whole-mouth Plaque Index scores (7.0%), in Plaque Index scores measured at interproximal sites (6.4%), and in Plaque Severity Index scores (24.5%). When compared to the control mouthrinse group, the 0.05% CPC mouthrinse group presented statistically significant greater reductions in whole-mouth Plaque Index scores (27.9%), in Plaque Index scores measured at interproximal sites (27.9%), and in Plaque Severity Index scores (81.1%) after six weeks of product use. With regard to gingivitis, after six weeks of product use, subjects using the 0.05% CPC mouthrinse exhibited statistically significant reductions from baseline in whole-mouth Gingival Index scores (25.0%), in Gingival Index scores measured at interproximal sites (25.3%), and in Gingivitis Severity Index scores (42.4%). Subjects using the control mouthrinse exhibited statistically significant reductions from baseline in whole-mouth Gingival Index scores (6.5%), in Gingival Index scores measured at interproximal sites (5.5%), and in Gingivitis Severity Index scores (11.6%). When compared to the control mouthrinse group, the 0.05% CPC mouthrinse group presented statistically significant greater reductions in whole-mouth Gingival Index scores (19.8%), in Gingival Index scores measured at interproximal sites (20.7%), and in Gingivitis Severity Index scores (35.5%) after six weeks of product use.
Conclusion: The results of this double-blind, parallel, six-week clinical study support the conclusion that a mouthrinse containing 0.05% CPC is efficacious for controlling established dental plaque and gingivitis. As measurements were conducted 12 hours after product use, the results also demonstrate that the 0.5% CPC mouthrinse provides 12-hour protection against plaque and gingivitis.