6-month use of 0.2% delmopinol hydrochloride in comparison with 0.2% 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 efficacy and safety of delmopinol hydrochloride 2 mg/ml (0.2% w/v, Decapinol Mouthwash) used for partly supervised mouthrinsing in comparison with chlorhexidine digluconate 2 mg/ml (0.2% w/v, Hibitane Dental, ICI Pharmaceuticals, UK) and placebo as an addition to normal oral hygiene. Assessments of efficacy were performed using the plaque index and 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<0.001) and 38% (p<0.001) after 3 and 6 months, respectively. Bleeding on probing was reduced for delmopinol in comparison with placebo by 11% after 3 months and by 18% (p<0.05) after 6 months. For chlorhexidine the corresponding figures were 18% (p<0.01) and 22% (p<0.01) after 3 and 6 months, respectively. While chlorhexidine showed greater plaque reduction than delmopinol (p<0.01 at 6 months), no statistically significant difference was reached between these two solutions regarding BOP. Both 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 both the delmopinol and the chlorhexidine groups. The number of patients withdrawn from treatment due to adverse events or lack of cooperation was 7 in the chlorhexidine group, 4 in the placebo group and 1 in the delmopinol group. The results showed that rinsing with either 0.2% delmopinol hydrochloride or 0.2% chlorhexidine digluconate twice daily for 60 secs for 6 months results in less plaque formation and gingivitis than rinsing with placebo. Mouthrinsing with the 0.2% delmopinol hydrochloride solution was well accepted in this study.

RCT Entities:   Population Interventions Outcomes