Objective To evaluate the effectiveness of topical fluoride on prevention of enamel demineralization during the orthodontic treatment in China. Methods The Cochrane Library(Issue 9, 2012), MEDLINE (1996 to 2012.10), EMbase (1974 to 2012.10), CNKI (1994 to 2012.10), VIP (1994 to 2012.10), WanFang data (1998 to 2012.10) and CBM (1978 to 2012.10) are searched for the randomized controlled trials (RCTs) and quasi-Randomized controlled trials (qRCTs) about topical fluoride preventing enamel demineralization during the orthodontic treatment. The bibliographies of the included studies were searched, too. Two reviewers evaluated the quality of the included studies and extracted data critically and independently, and then the extracted data were analyzed using RevMan 5.2 software. Results A total of 20 studies within 19 articles were included, which involved 26 323 teeth. The results of meta-analysis results show that, the rate of enamel demineralization of the fluoride varnish group (8.4%) was lower than that of the control group (16.0%) (OR=0.44, 95%CI 0.33 to 0.59, Plt;0.000 01); the rate of enamel demineralization of the fluoride coating group (8.3%) was lower than that of the control group (17.7%) (OR=0.46, 95%CI 0.35 to 0.60, Plt;0.000 01); the rate of enamel demineralization of the fluoride toothpaste group (9.0%) was lower than that of the control group (14.5%) (OR=0.59, 95%CI 0.49 to 0.71, Plt;0.000 01); the rate of enamel demineralization of the fluoride foam group (11.6%) was lower than that of the control group (18.2%) (OR=0.48, 95%CI 0.24 to 0.96, P=0.04); the rate of enamel demineralization of other groups (12.0%) was lower than that of the control group (21.8%) (OR=0.43, 95%CI 0.30 to 0.60, Plt;0.000 01). Two outcomes were low quality in the GRADE system and the other three are very low quality. Conclusion Current domestic evidence shows that topical fluoride is effective to prevent enamel demineralization during the orthodontic treatment. However, given the low methodological quality of most included studies, this conclusion still needs to be further proved by conducting more strictly-designed, high-quality and large-scale studies.