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Background: The role of cyclosporin in the absence of calcium channel blockers and the associated risk variables of development and severity of gingival overgrowth have not yet been properly established. The present study was conducted to determine the effect of potential risk variables for gingival overgrowth severity in Brazilian renal transplant subjects medicated with cyclosporin in the absence of any calcium channel blockers. Methods: A cross-sectional study was conducted in a public hospital in Belo Horizonte, Brazil. Demographic, pharmacologic, and periodontal data, recorded from 194 subjects taking cyclosporin in the absence of calcium channel blockers, were analyzed using independent sample t, χ² statistic, or Mann-Whitney U tests. The effects of potential risk variables of gingival overgrowth severity were determined using backward stepwise regression analysis. Results: The prevalence of clinically significant gingival over growth was 34.5% (N = 67). These subjects presented a significantly higher papillary bleeding index and a higher plaque index compared to those without clinically significant gingival overgrowth. When all demographic, pharmacologic, and periodontal data were evaluated in relation to gingival overgrowth severity, time since transplant, papillary bleeding index, serum cyclosporin concentration, and prednisolone and azathioprine dosages were significant in the univariate modeling (P <0.05) and remained significant when evaluated in the multivariate modeling (P<0.0001; adjusted R² = 39.4%). Conclusions: In the absence of calcium channel blockers, this study showed that pharmacologic variables, such as cyclosporin serum concentration, prednisolone and azathioprine dosages, and time since transplant, are strongly related to gingival over growth. In addition, the periodontal variable papillary bleeding index highlighted the primary role of inflammation on the pathogenesis and severity of gingival overgrowth. J Periodontol 2007;78:254-261. [ABSTRACT FROM AUTHOR]