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Background: Some reports suggest that the prevalence and severity of gingival overgrowth (GO) is lower in patients taking tacrolimus (Tcr) than in those taking cyclosporin A (CsA). The present study was conducted to determine the prevalence and severity of GO in a group of renal transplant recipients treated with Tcr in comparison to those treated with CsA and to evaluate the risk variables associated with the development of G O in these two drug regimens. Methods: A cross sectional study was conducted in a public hospital in Belo Horizonte City, Brazil, Demographic, pharmacological, and periodontal data were recorded for each subject. Variables from 134 subjects taking Tcr were compared to 451 subjects taking CsA using independent sample t, χ2 statistic, or Mann Whitney tests. The effects of potential risk factors on GO severity were determined using forward and backward stepwise regression analysis. Results: Subjects taking CsA showed a higher mean GO score (29.03% ± 22.9%) compared to subjects taking Tcr (16.9% ± 3.4%) (P=0.0038). In the Tcr group, 17.9% of the subjects had clinically significant GO compared to 38.1% in the CsA group (P= 0.045). In the multivariate final model, papillary bleeding index, azathioprine dosage, and concomitant use of calcium channel blockers (CCB) were significant variables associated with severity of GO in Tcr and CsA groups. In addition, previous CsA use also remained significant for GO in subjects under a Tcr regimen. Conclusions: The prevalence and severity of GO is lower in transplant subjects taking Tcr compared to CsA. GO severity in both groups was strongly associated with the papillary bleeding index, highlighting the role of inflammation in this condition, Concomitant CCB use, azathioprine dosage, and previous CsA use in the Tcr group reinforces the possible synergistic effects of these pharmacological variables on GO severity. [ABSTRACT FROM AUTHOR]