6-MONTH USE OF 0.2-PERCENT DELMOPINOL HYDROCHLORIDE IN COMPARISON WITH 0.2-PERCENT CHLORHEXIDINE DIGLUCONATE AND PLACEBO(I) - EFFECT ON PLAQUE-FORMATION AND GINGIVITIS

A double-blind, randomised, 6-month clinical trial with parallel group design in 149 patients with gingivitis was conducted to study the eff icacy and safety of delmopinol hydrochloride 2 mg/ml (0.2% w/v, Decapi nol Mouthwash) used for partly supervised mouthrinsing in comparison w ith chlorhexidine digluconate 2 mg/ml (0.2% w/v, Hibitane Dental (R), ICI Pharmaceuticals, UK) and placebo as an addition to normal oral hyg iene. Assessments of efficacy were performed using the plaque index an d bleeding on probing (BOP). Delmopinol showed 22% lower plaque index scores than placebo after 3 months (p<0.01) and 13% lower scores after 6 months. The corresponding figures for chlorhexidine were 38% (p<0.0 01) and 38% (p<0.001) after 3 and 6 months, respectively. Bleeding on probing was reduced for delmopinol in comparison with placebo by 11% a fter 3 months and by 18% (p<0.05) after 6 months. For chlorhexidine th e corresponding figures were 18% (p<0.01) and 22% (p<0.01) after 3 and 6 months, respectively. While chlorhexidine showed greater plaque red uction than delmopinol(p<0.01 at 6 months), no statistically significa nt difference was reached between these two solutions regarding BOP. B oth active solutions showed an increased amount of dental calculus in comparison with placebo. A transient anaesthetic sensation in the oral mucosa and taste affection were commonly reported adverse events in b oth the delmopinol and the chlorhexidine groups. The number of patient s withdrawn from treatment due to adverse events or lack of cooperatio n was 7 in the chlorhexidine group, 4 in the placebo group and 1 in th e delmopinol group. The results showed that rinsing with either 0.2% d elmopinol hydrochloride or 0.2% chlorhexidine digluconate twice daily for 60 sees for 6 months results in less plaque formation and gingivit is than rinsing with placebo. Mouthrinsing with the 0.2% delmopinol hy drochloride solution was well accepted in this study.