Meta-analyses of studies of 0.2% delmopinol mouth rinse as an adjunct to gingival health and plaque control measures.

BACKGROUND Delmopinol is a third-generation anti-plaque agent used as a mouthwash to reduce plaque and alleviate gingivitis. OBJECTIVE To create an overview of the anti-plaque efficacy of 0.2% delmopinol as an adjunct to normal oral hygiene measures by meta-analysis of completed clinical trials. MATERIALS AND METHODS Eight double-blind, parallel-group studies were identified. Study durations ranged from 8 to 24 weeks. Five studies (n=913) involved supervised rinsing; three studies (n=467) involved unsupervised rinsing. These sets of trials were analysed separately and in combination. Efficacy outcomes comprised modified plaque index, modified gingival index (MGI) and gingival bleeding on probing (BOP). RESULTS Delmopinol 0.2% was superior to placebo for the reduction of plaque scores in both sets of studies. Effects on MGI and BOP were also better with delmopinol 0.2% than with placebo. In most instances, 95% confidence intervals were wholly in favour of delmopinol. Pooled analysis of all eight studies confirmed statistically significant effects of delmopinol 0.2% compared with placebo (p<0.00001). Delmopinol met the efficacy criteria of the American Dental Association in studies of extended duration. CONCLUSION Delmopinol 0.2% mouthwash is effective as an adjunct measure for reducing plaque burden and indices of gingivitis, whether or not it is used under supervision.