The aim of this study was to perform a systematic review of prevalence studies to determine the rate of malignant transformation of oral leukoplakia and assess the influence of demographic factors (age, gender, and geographic region) on the overall transformation rate.A search was conducted for publications until July 2019 in 4 electronic databases and peer-reviewed journals. A manual search was performed on the bibliographies of the collected articles, and the authors were contacted for additional information. This study was previously registered with the trial number CRD42019126909 and study quality assessed through established methods. The results were expressed by means of proportions or odds ratios with a 95% confidence interval. Meta-regression was undertaken to evaluate possible sources of heterogeneity, and funnel plot visual analysis was performed to assess publication bias.The 34 observational epidemiologic studies included reported data on 26,209 patients with oral leukoplakia from 18 different countries. Meta-analysis of 32 studies (23,489 patients) presented an estimated overall mean proportion of malignant transformation rate of 9.70% (7.80-11.70) (I2 = 98.66%; τ2 < 0.001; χ2 = 23.18; degrees of freedom [df] = 31). When comparing genders, the odds ratio favored males with 0.622 (0.468-0.826) (I2 = 29.77%; τ2 = 0.089; χ2 = 22.78; df = 16).Within the limitations of the included studies in this systematic review, the results suggest that the malignant transformation rate was dependent on demographic factors and follow-up time. Future studies should include the development of guidelines to standardize the methodology for long-term follow-up assessment, thus reducing the risk of bias.