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 The number of patients withdrawn from treatment due to adverse events or lack of cooperation was 7 in the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.