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Randomized Controlled Trial
. 2015 Aug 14;219(3):125-30.
doi: 10.1038/sj.bdj.2015.592.

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

A Jose  1 , A Butler  1 , D Payne  2 , R Maclure  2 , P Rimmer  2 , M L Bosma  1
Affiliations
Randomized Controlled Trial

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

A Jose et al. Br Dent J. .

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 ≥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.

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Figures

Figure 1
Figure 1. Patient disposition.
*One adverse event was joint dislocation and the second was dysgeusia and paraethesia oral. **Non-compliance was main violation and was determined before unblinding. ITT: intent to treat; PP: per protocol
Figure 2
Figure 2. Summary of efficacy results (ITT population).
(a) GSI by time and treatment; (b) GI by time and treatment; (c) PI by time and treatment. Raw means are presented at week 0. Adjusted means are presented at week 6
See this image and copyright information in PMC

References

    1. Loë H, Theidale E, Jensen S B. Experimental gingivitis in man. J Peridontol 1965; 36: 177–187. - PubMed
    1. Theilade E, Wright W H, Jensen S B, Loë H. Experimental gingivitis in man II. A longitudinal clinical and bacteriological investigation. J Periodontal Res 1966; 1: 1–13. - PubMed
    1. Timmerman M F, Van der Weijen G A. Risk factors for periodontitis. Int J Dent Hyg 2006; 4: 2–7. - PubMed
    1. Van der Weijen F, Slot D E. Oral hygiene in the prevention of periodontal diseases: the evidence. Periodontol 2000 2011; 55: 104–123. - PubMed
    1. Van strydonck D A C, Slot D E, Van der Velden U, Van der Weijen F. Effect of a chlorhexidine mouthrinse on plaque, gingival inflammation and staining in gingivitis patients: a systematic review. J Clin Periodontol 2012; 39: 1042–1055. - PubMed

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