A 6-MONTH HOME-USAGE TRIAL OF 0.1-PERCENT AND 0.2-PERCENT DELMOPINOL MOUTHWASHES .1. EFFECTS ON PLAQUE, GINGIVITIS, SUPRAGINGIVAL CALCULUS AND TOOTH STAINING

Delmopinol is a morpholinoethanol derivative which, in mouthrinses use d in the absence of normal oral hygiene, has been shown effective in t he inhibition of plaque and gingivitis. The aim of this study was to d etermine the adjunctive oral hygiene benefits and safety of delmopinol rinses when used alongside normal toothcleaning. This 6-month home us e study was a placebo-controlled, double-blind, randomised parallel de sign evaluating 0.1% and 0.2% delmopinol rinses and structured to conf orm with the ADA Council of Dental Therapeutics guidelines. A total of 450 dentate male and female subjects were recruited who had no releva nt medical or pharmacotherapy histories determined from a full medical examination, including haematological and biochemical tests. Subjects had moderate levels of plaque and gingivitis. At baseline, 3 and 6 mo nths subjects were scored for plaque. gingivitis, tooth stain and supr agingival calculus, with plaque sampled for microbiological analysis, Additionally, oral mucosal examinations were performed and subjects qu estioned for adverse symptoms. Baseline special tests were repeated at the end of the study. After baseline examinations, the subjects recei ved a professional prophylaxis, provided with the allocated mouthwash and instructed to use 10-ml volumes for 60 s 2xdaily and where appropr iate after toothbrushing and meals, Demographic features of the 3 grou ps were similar and losses to trial were small. Adverse signs and symp toms included transitory numbness of the tongue, tooth and tongue stai ning, taste disturbance and rarely mucosal soreness and erosion. All l ocal side-effects were less commonly reported at 6 compared to 3 month s and only 6 subjects were withdrawn because of adverse event. No syst emic effects attributable to the agent were observed and no significan t shifts in haematological or biochemical parameters occurred. All gro ups showed considerable improvements in oral hygiene and gingival heal th with some significant differences in favour of 0.2% delmopinol comp ared to placebo for gingivitis and more particularly plaque. Staining was also significantly increased in the delmopinol groups but not calc ulus. In the present study, a considerable Hawthorne effect occurred, which must in part explain why only a modestly significant effect was achieved. (C) Munksgaard, 1996.