Clinical evaluation of a mouthrinse in supportive periodontal care

Objectives: To evaluate the clinical activity and safety of a mouthrinse containing 0.05% cetyl-pyridinium chloride and 0.05% chlorhexidine in patients on supportive periodontal care (SPC). Methods: This investigation was designed as a randomized, double-blinded, placebo-controlled clinical trial. 34 subjects with a history of chronic periodontitis patients and currently on SPC were selected on the bases of demonstrating an inadequate plaque control (Turesky index >1). After a supragingival profilaxis and oral hygiene reinforcement, they were asked to rinse twice a day for 3 months with either the test or placebo rinse. Primary outcome variables included plaque and gingival indices (Turesky and Mühlemann-Son, respectively). Probing pocket depths, bleeding on probing and probing atachment levels were also examined as secondary outcome variables. The appearance of undesirable side effects, such as staining, burning feeling and soft-tissue irritation were also recorded. Outcome variables were compared by the ANCOVA test for the parametric data and the chi-square test for the nominal data. Results: Plaque index was significantly reduced in the test group (-0.68; confidence interval (CI): -0.96 to 0.39) while in the control group the plaque index increased (+0.32; CI: +0.01 to +0.64). Differences between groups were statistically significant (p=0.0001). Bleeding on probing was also reduced in the test group (-0.09), while it increased in the control group (+0.08), being the differences between groups statistically significant (p=0.01). The gingival index was reduced in both groups, and no significant differences were detected between them. The same was true for changes in probing pocket depths. In regards to the safety of the tested product, when compared with the placebo rinse, differences were found for tooth staining (p=0.07) and burning sensation (p=0.08). Conclusions: The tested mouthwash demonstrated significant efficacy in reducing plaque and bleeding in patients undergoing SPC but demonstrating an inadequate mechanical plaque control. Supported by Dentaid.