Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic and oral complications, such as periodontitis. The use of adjunctive local and/or systemic antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ) and amoxicillin (AMX) has been largely recognized as an effective therapy for improving the clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis (ChP). However, no previous clinical trials to date have evaluated the effects of this antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore, the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2 diabetic subjects with generalized ChP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.
Administration of placebo for 14 days started immediately after the first session of SRP.
Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.
University of Guarulhos
Guarulhos, São Paulo, Brazil
Changes in number of sites with probing depth (PD) ≥5 mm post-treatment
Time frame: From baseline to 12 months
PD and clinical attachment level (CAL) changes at initially moderate sites
Time frame: From baseline to 12 months and from baseline to 24 months
PD and CAL changes at initially deep sites
Time frame: From baseline to 12 months and from baseline to 24 months
Changes in number of sites with PD ≥5mm
Time frame: From baseline to 12 months and from baseline to 24 months
Full-mouth PD and CAL
Time frame: Baseline, 3, 6, 12 and 24 months
Full-mouth percentages of sites with plaque
Time frame: Baseline, 3, 6, 12 and 24 months
Full-mouth percentages of sites with marginal bleeding
Time frame: Baseline, 3, 6, 12 and 24 months
Full-mouth percentages of sites with bleeding on probing
Time frame: Baseline, 3, 6, 12 and 24 months
Full-mouth percentages of sites with suppuration
Time frame: Baseline, 3, 6, 12 and 24 months
Full-mouth percentages of sites with PD ≥5mm
Time frame: Baseline, 3, 6,12 and 24 months
Serum levels of glycated hemoglobin (HbA1c)
Time frame: Baseline, 3, 6, 12 and 24 months
Serum levels of fasting plasma glucose FPG
Time frame: Baseline, 3, 6, 12 and 24 months
Levels of periodontal pathogenic bacterial species
Time frame: Baseline, 3, 6, 12 and 24 months
Occurrence of adverse events
Time frame: 14 days
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