A 6-month home-usage trial of 0.1% and 0.2% delmopinol mouthwashes (I). Effects on plaque, gingivitis, supragingival calculus and tooth staining

Delmopinol is a morpholinoethanol derivative which, in mouthrinses used in the absence of normal oral hygiene, has been shown effective in the inhibition of plaque and gingivitis. The aim of this study was to determine the adjunctive oral hygiene benefits and safety of delmopinol rinses when used alongside normal toothcleaning. This 6-month home use study was a placebo-controlled, double-blind, randomised parallel design evaluating 0.1% and 0.2% delmopinol rinses and structured to conform with the ADA Council of Dental Therapeutics guidelines. A total of 450 dentate male and female subjects were recruited who had no relevant 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 months subjects were scored for plaque, gingivitis, tooth stain and supragingival calculus, with plaque sampled for microbiological analysis. Additionally, oral mucosal examinations were performed and subjects questioned for adverse symptoms. Baseline special tests were repeated at the end of the study. After baseline examinations, the subjects received a professional prophylaxis, provided with the allocated mouthwash and instructed to use 10-ml volumes for 60 s 2 x daily and where appropriate after toothbrushing and meals. Demographic features of the 3 groups were similar and losses to trial were small. Adverse signs and symptoms included transitory numbness of the tongue, tooth and tongue staining, taste disturbance and rarely mucosal soreness and erosion. All local side-effects were less commonly reported at 6 compared to 3 months and only 6 subjects were withdrawn because of adverse event. No systemic effects attributable to the agent were observed and no significant shifts in haematological or biochemical parameters occurred. All groups showed considerable improvements in oral hygiene and gingival health with some significant differences in favour of 0.2% delmopinol compared to placebo for gingivitis and more particularly plaque. Staining was also significantly increased in the delmopinol groups but not calculus. In the present study, a considerable Hawthorne effect occurred, which must in part explain why only a modestly significant effect was achieved.