A 6-month clinical study assessing the safety and efficacy of two cetylpyridinium chloride mouthrinses.

PURPOSE

To evaluate the effects of two experimental cetylpyridinium chloride (CPC) mouthrinses containing 0.075% and 0.10% CPC on the development of gingivitis and plaque versus a placebo control over a period of 6 months.

METHODS

This was a randomized, single center, parallel group, double blind, positive and placebo controlled clinical trial. A 0.12% chlorhexidine rinse served as the positive control for validation of the methodology. At the beginning of the trial, 366 subjects were balanced and randomly assigned to treatment groups. Subjects received a dental prophylaxis and began rinsing twice a day with 15 ml of their assigned mouthwash for 30 seconds after brushing their teeth. Subjects were assessed for gingivitis and gingival bleeding by the Löe-Silness Gingival Index method and plaque by the Turesky modification of Quigley Hein Plaque Index at baseline and after 3 and 6 months of product use. Oral soft tissue health was also assessed.

RESULTS

After 3 and 6 months, subjects rinsing with either 0.075% or 0.10% CPC had significantly (P< 0.0001) less gingivitis, gingival bleeding, and plaque, on average, than those on placebo. The 6-month mean reductions in gingivitis, gingival bleeding, and plaque for the 0.075% and 0.10% CPC rinses versus placebo were 23%, 30% and 17%, and 20%, 27% and 19%, respectively. There was no statistically significant difference in efficacy between the two CPC mouthrinses. Reductions at 3 months were similar to those seen at 6 months. Significant benefits were observed with chlorhexidine, thereby validating the study.

CLINICAL SIGNIFICANCE

This study clearly demonstrates that CPC mouthrinses formulated to deliver therapeutic benefits when used twice daily can significantly prevent the development of gingivitis, gingival bleeding, and plaque over a 6-month period.