Summary Background Proper oral hygiene and absence of periodontal inflammation is pre-requisite for orthodontic treatment. Chlorhexidine (CHX) is an established oral antiseptic used in the treatment of periodontal disease, but its role in orthodontic therapy is unclear. Objectives To assess the efficacy of adjunct use of CHX-containing products in maintaining gingival health among orthodontic patients with fixed appliances. Search methods Five databases were searched without limitations up to August 2021. Selection criteria Randomized clinical trials (RCTs) assessing Gingival Index (GI) (primary outcome), Plaque Index (PI), Bleeding Index (BI), or Pocket Probing Depth (PPD). Data collection and analysis Study selection, data extraction, and risk of bias assessment were done independently in duplicate. Random-effects meta-analyses of mean differences (MDs) or standardized mean differences (SMDs) with their 95% confidence intervals (CIs) were conducted, followed by sensitivity and Grades of Recommendations, Assessment, Development and Evaluation analysis. Results Twenty RCTs (1001 patients) were included assessing CHX-containing mouthwashes (n = 11), toothpastes (n = 2), gels (n = 3), or varnishes (n = 4) compared to placebo/control (n = 19) or sodium fluoride-products (n = 4). In the short-term, CHX-containing mouthwash was associated with lower GI (n = 9; MD = −0.68; 95% CI = −0.97 to −0.38; P < 0.001; high quality), lower PI (n = 9; MD = −0.65; 95% CI = −0.86 to −0.43; P < 0.001; high quality), lower BI (n = 2; SMD = −1.61; 95% CI = −2.99 to −0.22; P = 0.02; low quality), and lower PPD (n = 2; MD = −0.60 mm; 95% CI = −1.06 to −0.14 mm; P = 0.01; low quality). No considerable benefits were found from the use of CHX-gel or CHX-varnish in terms of GI, PI, or PPD (P > 0.05/low quality in all instances). Use of a CHX-containing toothpaste was more effective in lowering PI (Heintze-index) than adjunct use of fluoride-containing mouthwash (n = 2; MD = −5.24; 95% CI = −10.46 to −0.02; P = 0.04), but not GI (P = 0.68) or BI (P = 0.27), while sensitivity analyses indicated robustness. Conclusions Adjunct use of CHX mouthwash during fixed-appliance treatment is associated with improved gingival inflammation, plaque control, and pocket depths, but caution is warranted and recommendations about CHX use during orthodontic treatment of children/adults should consider the heterogeneous patient response, cost-effectiveness, and potential adverse effects. Registration PROSPERO registration (CRD42021228759).
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