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 6 months, the clinical, glycemic and microbiological effects of systemic metronidazole and amoxicillin as adjunctive to scaling and root planing (SRP) in uncontrolled type 2 diabetic subjects with chronic periodontitis. Forty subjects with chronic periodontitis and type 2 diabetes will be divided into one of the following therapeutic groups: Control (n=20) SRP + placebo; Test (n=20): RAR + systemic metronidazole (400mg) + amoxicillin (500mg), 3x/day for 10 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) microbiological evaluation by quantitative PCR of the bacterial species: Prevotella intermedia, Porphyromonas gingivalis, Tanerella forsythia, Eubacterium nodatum and Parvimona micra. Clinical and microbiological parameters and the levels of glycated hemoglobin and fasting plasma glucose will be assessed before and at 3 and 6 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%.