Clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride in preventing 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% cetylpyridinium chloride (CPC) in preventing dental plaque build-up relative to that of a control mouthrinse without 0.05% CPC.

METHODS

Adult male and female subjects from the São Paulo, Brazil 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. Subjects qualifying for participation received a complete dental prophylaxis. 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.

RESULTS

Forty-three subjects complied with the protocol and completed the study. Results demonstrated that after seven days of product use, mean plaque levels were statistically significantly lower (p < 0.05) than the pre-prophylaxis levels for both treatment groups. The mean plaque level for the CPC mouthrinse group was 46.1% of the pre-prophylaxis plaque level, whereas the mean plaque level for the control mouthrinse group was 75.5% of the pre-prophylaxis plaque level. The results demonstrate a statistically significant reduction in plaque build-up for the CPC mouthrinse group (29.3%) as compared to the control group.

CONCLUSION

The overall results from 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 in preventing dental plaque build-up than a control mouthrinse without 0.05% CPC. As measurements were made 12 hours after final product use, the results also demonstrate that the CPC rinse provides 12-hour protection against dental plaque build-up.