To assess genotoxic and cytotoxic effect of commercially available toothpastes with the different whitening ingredients. In vivo assessment of cytotoxicity and genotoxicity of whitening toothpastes with different ingredients using a buccal micronucleus cytome assay (BMCyt assay) comprised 199 participants randomly divided into ten groups based on used whitening or control/conventional toothpaste. The exfoliated buccal mucosal cells were collected, stained, and microscopically evaluated at baseline (T0), 30 days (T1), and 60 days (T2) after the beginning of treatment and 30 days after completing treatment (T3). Statistical evaluation was performed by repeated-measures analysis of variance (two-way ANOVA), Tukey's test, and multiple regression analysis. The genotoxic parameters showed no biologically significant changes in any of the observed period for the tested toothpastes, while cytotoxic parameters (number of cells with karyorrhexis and condensed chromatin) showed statistically significant difference (P < 0.05) among evaluation periods for the three peroxide-containing toothpastes. Peroxide-containing whitening toothpastes exhibit an increase in certain cytotoxic parameters only during the application period, which return to control values after the cessation of application. Whitening toothpastes show no genotoxic effect, while peroxide-containing whitening toothpastes may present significant increase of cytotoxicity (measured by the number of karyorrhexis and condensed chromatin) during the application period. However, these changes observed in clinical conditions cannot be considered significant. ClinicalTrials.gov: NCT04460755.
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