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Notes: Abstract 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 haematoiogical 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 2Xdaily and where appropriate after tooth brushing 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 All local side-effects were less commonly reported at 6 compared to 3 months and only 6 subjects were withdrawn because of adverse event.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.

Notes: Abstract. The effects of 0.1% and 0.2% delmopinol mouthwashes on supragingival plaque flora were investigated in a 6-month home-use study. 141 subjects were studied from whom plaque was collected at baseline. 12. 24 and 36 weeks. Overall, there were no consistent effects on microscopic or total counts. However, there was a significant reduction in the proportion of dextran-producing streptococci in the active groups compared to the control group throughout treatment. There was no colonisation by Candida or Gram-negative aerobic bacilli in the active groups nor was there any decrease in susceptibility to delmopinol. Delmopinol appears to mediate its anti-plaque effect without causing a major shift in bacteria! populations, although dextran-producing bacteria appear to be affected, which may have relevance to this agent's mode of action.

Notes: Abstract. Delmopinol has been considered as a potential agent for the chemical control of plaque. The aims of these studies were to measure the effects of a 0.2% delmopinol hydrochloride mouthrinse on (1) plaque reformation and (2) salivary bacterial counts. Comparisons were made with a 0.2% chlorhexidine rinse and a placebo rinse. A group of 12 male volunteers took part in the plaque study which was of a double blind, randomised, 3 cell, cross-over design. From a zero plaque baseline subjects rinsed, 2 × a day, under supervision, for 1 min with 10-ml volumes of the allocated rinse. After 4 days, during which no other form of oral hygiene was performed, plaque was scored by area and index. Plaque results were significantly lower with chlorhexidine and delmopinol compared with control, and with chlorhexidine compared to delmopinol. Side-effects with delmopinol were transient tingling and numbness of the tongue in some subjects. A 2nd group of 12 male volunteers received single, 1-min rinses of the 3 formulations. Salivary bacterial counts were determined immediately before and up to 420 min after rinsing. Compared to the control rinse, chlorhexidine significantly reduced bacterial counts of 420 min. Delmopinol produced a small reduction in bacterial counts which was only significantly different from control at one time point. Delmopinol deserves further evaluation as a chemical plaque inhibitor, particularly when used as an adjunct to normal toothcleaning.