A randomised clinical study to evaluate the efficacy of alcohol-free or alcohol-containing mouthrinses with chlorhexidine on gingival bleeding

Abstract

Objectives Gingival bleeding following twice-daily use of 0.2% w/v chlorhexidine digluconate mouthrinse with and without alcohol (0.2% CHX-alcohol; 0.2% CHX-alcohol-free, respectively) and brushing with a standard fluoride toothpaste was compared to brushing alone.Methods Three hundred and nineteen subjects with mild-to-moderate gingivitis (with a16 gradable permanent teeth including four molars, bleeding after brushing and a20 bleeding sites) completed this randomised, examiner-blinded, parallel-group study. A prophylaxis was performed at baseline. Gingival Severity Index (GSI; primary objective), Gingival Index (GI) and Plaque Index (PI) were assessed at baseline and after 6 weeks of treatment. Adverse events (AEs) were recorded throughout the study.Results Between treatment differences at week 6 demonstrated significantly lower GSI for the 0.2% CHX-alcohol and 0.2% CHX-alcohol-free groups compared to brushing alone (primary endpoint; treatment difference a0.061 [95% CI a0.081, a0.041] and a0.070 [95% CI a0.090, a0.050], respectively; both p <0.0001). There were also significant reductions in GI and PI for the 0.2% CHX-alcohol and 0.2% CHX-alcohol-free groups compared to brushing alone (all p <0.0001). The proportion of subjects reporting a1 treatment-related adverse events (TRAEs) was 27.8% (0.2% CHX-alcohol), 24.8% (0.2% CHX-alcohol-free) and 3.7% (brushing alone).Conclusions Chlorhexidine mouthrinse with or without alcohol as an adjunct to brushing with regular fluoride toothpaste significantly reduces bleeding scores, plaque and gingival inflammation compared to brushing alone. TRAEs are characteristic of those associated with the use of chlorhexidine and are similar for both mouthrinses.