A randomised clinical study to evaluate the efficacy of alcohol-free or alcohol-containing mouthrinses with chlorhexidine on gingival bleeding.
OBJECTIVE
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 ≥16 gradable permanent teeth including four molars, bleeding after brushing and ≥20 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 -0.061 [95% CI -0.081, -0.041] and -0.070 [95% CI -0.090, -0.050], 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 ≥1 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.
GSK Consumer Healthcare, St George's Avenue, Weybridge, KT13 0DE.
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Jose
GSK Consumer Healthcare, St George's Avenue, Weybridge, KT13 0DE.
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Butler
Intertek Clinical Research Services, Wirral and Manchester, UK.
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Payne
Intertek Clinical Research Services, Wirral and Manchester, UK.
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Maclure
Intertek Clinical Research Services, Wirral and Manchester, UK.
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Rimmer
GSK Consumer Healthcare, St George's Avenue, Weybridge, KT13 0DE.
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Bosma
D002710:Chlorhexidine / Q000009:adverse effects*; D003773:Dental Plaque / Q000517:prevention & control*; D005260:Female; D005884:Gingival Hemorrhage / Q000209:etiology*; D006801:Humans; D008297:Male; D009067:Mouthwashes / Q000009:adverse effects*
D009067:Mouthwashes; D002710:Chlorhexidine