Systemic metronidazole and amoxicillin as adjuncts to scaling and root planing in the treatment of chronic periodontitis in type 2 diabetic subjects: clinical, glycemic and microbiological evaluations

Abstract

The aim of this double-blinded, prospective, randomized, placebo-controlled clinical trial will be to evaluate, at 3 and 12 months, the clinical, glycemic and microbiological effects of systemic metronidazol and amoxicillin as adjunctive to scaling and root planing (SRP) in uncontrolled type 2 diabetic subjects with chronic periodontitis. Fifty subjects with chronic periodontitis and type 2 diabetes will be assigned into one of the following therapeutic groups: Control (n=25) SRP + placebo; Test (n=25): RAR + systemic metronidazole (400mg) + amoxicillin (500mg), 3x/day for 14 days. The following clinical parameters will be evaluated: probing depth (PD), clinical attachment level (CAL), visible plaque accumulation, bleeding on probing, marginal bleeding and suppuration. Six subgingival biofilm samples will be collected per subjects (3 samples PD < 5 mm e 3 samples PD e 5 mm) for the evaluation by quantitative PCR of the following bacterial species: Prevotella intermedia, Porphyromonas gingivalis, Tanerella forsythia, Eubacterium nodatum, Parvimona micra and Fusobacterium nucleatum e Treponema denticola. Clinical and microbiological parameters and the levels of glycated hemoglobin and fasting plasma glucose will be assessed before and at 3 and 12 months post-therapies. Intra-group comparisons (before and after treatment) will be performed by Friedman test or repeated measured ANOVA, according to data normality. Inter-group comparisons (control/test) within each time-point will be performed by Mann-Whitney test and t-test. The level of significance will be set at 5%. (AU)