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Meta-Analysis
. 2017 Mar 31;3(3):CD008676.
doi: 10.1002/14651858.CD008676.pub2.

Chlorhexidine mouthrinse as an adjunctive treatment for gingival health

Patrice James  1 , Helen V Worthington  2 , Carmel Parnell  3 , Mairead Harding  4 , Thomas Lamont  5 , Andrea Cheung  6 , Helen Whelton  7 , Philip Riley  2
Affiliations
Meta-Analysis

Chlorhexidine mouthrinse as an adjunctive treatment for gingival health

Patrice James et al. Cochrane Database Syst Rev. .

Abstract

Background: Dental plaque associated gingivitis is a reversible inflammatory condition caused by accumulation and persistence of microbial biofilms (dental plaque) on the teeth. It is characterised by redness and swelling of the gingivae (gums) and a tendency for the gingivae to bleed easily. In susceptible individuals, gingivitis may lead to periodontitis and loss of the soft tissue and bony support for the tooth. It is thought that chlorhexidine mouthrinse may reduce the build-up of plaque thereby reducing gingivitis.

Objectives: To assess the effectiveness of chlorhexidine mouthrinse used as an adjunct to mechanical oral hygiene procedures for the control of gingivitis and plaque compared to mechanical oral hygiene procedures alone or mechanical oral hygiene procedures plus placebo/control mouthrinse. Mechanical oral hygiene procedures were toothbrushing with/without the use of dental floss or interdental cleaning aids and could include professional tooth cleaning/periodontal treatment.To determine whether the effect of chlorhexidine mouthrinse is influenced by chlorhexidine concentration, or frequency of rinsing (once/day versus twice/day).To report and describe any adverse effects associated with chlorhexidine mouthrinse use from included trials.

Search methods: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 28 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 8) in the Cochrane Library (searched 28 September 2016); MEDLINE Ovid (1946 to 28 September 2016); Embase Ovid (1980 to 28 September 2016); and CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to 28 September 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.

Selection criteria: We included randomised controlled trials assessing the effects of chlorhexidine mouthrinse used as an adjunct to mechanical oral hygiene procedures for at least 4 weeks on gingivitis in children and adults. Mechanical oral hygiene procedures were toothbrushing with/without use of dental floss or interdental cleaning aids and could include professional tooth cleaning/periodontal treatment. We included trials where participants had gingivitis or periodontitis, where participants were healthy and where some or all participants had medical conditions or special care needs.

Data collection and analysis: Two review authors independently screened the search results extracted data and assessed the risk of bias of the included studies. We attempted to contact study authors for missing data or clarification where feasible. For continuous outcomes, we used means and standard deviations to obtain the mean difference (MD) and 95% confidence interval (CI). We combined MDs where studies used the same scale and standardised mean differences (SMDs) where studies used different scales. For dichotomous outcomes, we reported risk ratios (RR) and 95% CIs. Due to anticipated heterogeneity we used random-effects models for all meta-analyses.

Main results: We included 51 studies that analysed a total of 5345 participants. One study was assessed as being at unclear risk of bias, with the remaining 50 being at high risk of bias, however, this did not affect the quality assessments for gingivitis and plaque as we believe that further research is very unlikely to change our confidence in the estimate of effect. Gingivitis After 4 to 6 weeks of use, chlorhexidine mouthrinse reduced gingivitis (Gingival Index (GI) 0 to 3 scale) by 0.21 (95% CI 0.11 to 0.31) compared to placebo, control or no mouthrinse (10 trials, 805 participants with mild gingival inflammation (mean score 1 on the GI scale) analysed, high-quality evidence). A similar effect size was found for reducing gingivitis at 6 months. There were insufficient data to determine the reduction in gingivitis associated with chlorhexidine mouthrinse use in individuals with mean GI scores of 1.1 to 3 (moderate or severe levels of gingival inflammation). Plaque Plaque was measured by different indices and the SMD at 4 to 6 weeks was 1.45 (95% CI 1.00 to 1.90) standard deviations lower in the chlorhexidine group (12 trials, 950 participants analysed, high-quality evidence), indicating a large reduction in plaque. A similar large reduction was found for chlorhexidine mouthrinse use at 6 months. Extrinsic tooth staining There was a large increase in extrinsic tooth staining in participants using chlorhexidine mouthrinse at 4 to 6 weeks. The SMD was 1.07 (95% CI 0.80 to 1.34) standard deviations higher (eight trials, 415 participants analysed, moderate-quality evidence) in the chlorhexidine mouthrinse group. There was also a large increase in extrinsic tooth staining in participants using chlorhexidine mouthrinse at 7 to 12 weeks and 6 months. Calculus Results for the effect of chlorhexidine mouthrinse on calculus formation were inconclusive. Effect of concentration and frequency of rinsing There were insufficient data to determine whether there was a difference in effect for either chlorhexidine concentration or frequency of rinsing. Other adverse effects The adverse effects most commonly reported in the included studies were taste disturbance/alteration (reported in 11 studies), effects on the oral mucosa including soreness, irritation, mild desquamation and mucosal ulceration/erosions (reported in 13 studies) and a general burning sensation or a burning tongue or both (reported in nine studies).

Authors' conclusions: There is high-quality evidence from studies that reported the Löe and Silness Gingival Index of a reduction in gingivitis in individuals with mild gingival inflammation on average (mean score of 1 on the 0 to 3 GI scale) that was not considered to be clinically relevant. There is high-quality evidence of a large reduction in dental plaque with chlorhexidine mouthrinse used as an adjunct to mechanical oral hygiene procedures for 4 to 6 weeks and 6 months. There is no evidence that one concentration of chlorhexidine rinse is more effective than another. There is insufficient evidence to determine the reduction in gingivitis associated with chlorhexidine mouthrinse use in individuals with mean GI scores of 1.1 to 3 indicating moderate or severe levels of gingival inflammation. Rinsing with chlorhexidine mouthrinse for 4 weeks or longer causes extrinsic tooth staining. In addition, other adverse effects such as calculus build up, transient taste disturbance and effects on the oral mucosa were reported in the included studies.

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Conflict of interest statement

As former Director of the Oral Health Services Research Centre, Cork, Helen Whelton has conducted clinical trials of products for GlaxoSmithKline (GSK) and she received consultancy fees in relation to this research. Mairead Harding (Deputy Director of the Oral Health Services Research Centre) was involved in the development of educational materials with regard to tooth wear/dental erosion and has conducted epidemiological studies and presented the findings on tooth wear and dental erosion at conferences. Fees received from GlaxoSmithKline for this work were paid to the Oral Health Services Research Centre, Cork and not to Mairead Harding. Philip Riley is a salaried member of the Cochrane Oral Health editorial team. Editorial control of the review and final decisions about the content of the review were maintained by Helen Worthington who is Co‐ordinating Editor of Cochrane Oral Health. The remaining co‐authors declare no conflict of interest.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 1: Gingival Index (0‐3) 4‐6 weeks
1.2
1.2. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 2: Gingival Index (0‐3) 6 months
1.3
1.3. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 3: Gingival bleeding 4‐6 weeks
1.4
1.4. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 4: Gingival bleeding 6 months
1.5
1.5. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 5: Plaque 4‐6 weeks
1.6
1.6. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 6: Plaque 4‐6 weeks PI (0‐3)
1.7
1.7. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 7: Plaque 4‐6 weeks TQH (0‐5)
1.8
1.8. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 8: Plaque 6 months
1.9
1.9. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 9: Plaque 6 months PI (0‐3)
1.10
1.10. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 10: Plaque 6 months TQH (0‐5)
1.11
1.11. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 11: Calculus 4‐6 weeks
1.12
1.12. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 12: Calculus 7‐12 weeks
1.13
1.13. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 13: Calculus 6 months
1.14
1.14. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 14: Tooth staining 4‐6 weeks dichotomous
1.15
1.15. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 15: Tooth staining 7‐12 weeks dichotomous
1.16
1.16. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 16: Tooth staining 4‐6 weeks
1.17
1.17. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 17: Tooth staining 7‐12 weeks
1.18
1.18. Analysis
Comparison 1: CHX versus placebo/control mouthrinse or no mouthrinse, Outcome 18: Tooth staining 6 months
See this image and copyright information in PMC

Comment in

References

References to studies included in this review

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Grossman 1989 {published data only}
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Jenkins 1993 {published data only}
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Lopez‐Jornet 2012 {published data only}
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Sanz 1989 {published data only}
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Southern 2006 {published data only}
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References to studies excluded from this review

Bay 1975 {published data only}
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Leyes Borrajo 2002 {published data only}
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Madden 2008 {published data only}
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McKenzie 1992 {published data only}
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Nadkerny 2015 {published data only}
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NCT01750801 {published data only}
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NCT02546804 {published data only}
    1. NCT02546804. Evaluate the efficacy of potassium permanganate mouthwash and hot salt water mouthwash and their comparison with chlorhexidine mouthwash on plaque index, gingival index and periodontal probing depth. https://clinicaltrials.gov/show/NCT02546804 (first received 26 August 2015).
Ousehal 2011 {published data only}
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Paknejad 2006 {published data only}
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Persson 1991 {published data only}
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Priya 2015 {published data only}
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Quirynen 2005 {published data only}
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Quirynen 2006 {published data only}
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Radafshar 2017 {published data only}
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Saltini 1988 {published data only}
    1. Saltini C, Sanz M, Newman MG, Doherty F. Clinical efficacy of a 0.12% chlorhexidine mouthrinse in periodontal maintenance patients with persistent disease. Journal of Dental Research 1988;67(Spec Iss, IADR, AADR, CADR March 9-13 1988):183 (Abs No 567).
Segreto 1993 {published data only}
    1. Segreto V, Collins E. A clinical investigation to assess the effects on plaque, gingivitis, and staining potential of an experimental mouthrinse (research report on file). Cincinnati: Procter & Gamble; 1993. Report No: 002392.
Subhash 1985 {published data only}
    1. Subhash G, Das AK. The effect of chlorhexidine gluconate solution on gingivitis and its best mode of application. Journal of the Indian Dental Association 1985;57(12):501-4. - PubMed
Todkar 2012 {published data only}
    1. Todkar R, Sheikh S, Byakod G, Muglikar S. Efficacy of chlorhexidine mouthrinses with and without alcohol-A clinical study. Oral Health and Preventive Dentistry 2012;10:291-6. - PubMed
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Yates 2002 {published data only}
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References to studies awaiting assessment

CTRI/2011/05/001774 {published data only}
    1. CTRI/2011/05/001774. Non-inferiority efficacy study of 2 different formulations of 0.12% chlorhexidine gluconate oral rinse with (Oroclense) and without alcohol (Oroclear) for treatment of gingivitis. www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2390 (first received 31 May 2011).
NCT01898000 {published data only}
    1. NCT01898000. 'Triphala' - A new herbal mouthwash in gingivitis: a randomized controlled clinical trial. clinicaltrials.gov/show/NCT01898000 (first received 3 July 2013).
NCT02065414 {published data only}
    1. NCT02065414. Four weeks clinical efficacy of an Ethyl Lauroyl Arginate HCL (LAE) mouthrinse: effect on gingivitis. clinicaltrials.gov/show/NCT02065414 (first received 16 February 2014).
Radvar 2016 {published data only}
    1. Radvar M, Moeintaghavi A, Tafaghodi M, Ghanbari H, Fatemi K, Mokhtari MR, et al. Clinical efficacy of a herbal mouth wash composed of Salix alba, Malva sylvestrais and Althaea officinalis in chronic periodontitis patients. Journal of Herbal Medicine 2016;6(1):24-7.

References to ongoing studies

NCT02709785 {published data only}
    1. NCT02709785. SmartMouth Advanced Clinical Formula clinical research design protocol. clinicaltrials.gov/show/NCT02709785 (first received 9 March 2016).

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References to other published versions of this review

James 2010
    1. James P, Parnell C, Harding M, Whelton H, Worthington HV, Beirne PV. Chlorhexidine mouthrinse as an adjunctive treatment for gingival health. Cochrane Database of Systematic Reviews 2010, Issue 9. Art. No: CD008676. [DOI: 10.1002/14651858.CD008676] - DOI - PMC - PubMed

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