The aim of this study was to compare the clinical and microbiological outcomes of different dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP).
Randomized clinical trials and systematic reviews have shown that the use of the combination of metronidazole (MTZ) and amoxicillin (AMX) significantly improves the benefits of the SRP in the treatment of subjects with periodontitis. However, the optimal dosage and interval of administration of these antibiotics are still unclear. Therefore, the aim of this study was to compare the clinical and microbiological outcomes of different dosages and duration of the systemic administration of the combination of MTZ and AMX as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP). One hundred ten subjects will be randomly assigned to receive SRP plus placebo, or SRP combined with 250 mg or 400 mg of MTZ, plus AMX (500 mg) TID, for either 7 or 14 days. Subjects will be clinically and microbiologically monitored up to 1 year post-therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
SRP performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.
Subjects will intake Metronidazole 250 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.
Subjects will intake Metronidazole 400 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.
Guarulhos University
Guarulhos, São Paulo, Brazil
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
Time frame: 12 months
Number of sites with PD ≥ 5 mm
Time frame: Baseline, 3, 6 and 12 months
Number of sites with PD ≥ 6 mm
Time frame: Baseline, 3, 6 and 12 months
Number of sites with PD ≥ 7 mm
Time frame: Baseline, 3, 6 and 12 months
Reduction in the number of sites with PD ≥ 5 mm
Time frame: Baseline, 3, 6 and 12 months
Reduction in the number of sites with PD ≥ 6 mm
Time frame: Baseline, 3, 6 and 12 months
Reduction in the number of sites with PD ≥ 7 mm
Time frame: Baseline, 3, 6 and 12 months
Full-mouth PD
Time frame: Baseline, 3, 6 and 12 months
Full-mouth clinical attachment level
Time frame: Baseline, 3, 6 and 12 months
Percentage of sites with bleeding on probing
Time frame: Baseline, 3, 6 and 12 months
Percentage of sites with plaque accumulation
Time frame: Baseline, 3, 6 and 12 months
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Subjects will intake Metronidazole 250 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
Subjects will intake Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.
Subjects will intake placebo of Metronidazole 250 mg. for 7 days, starting immediately after to intake Metronidazole 250 mg.
Subjects will intake placebo of Metronidazole 400 mg. for 7 days, starting immediately after to intake Metronidazole 400 mg.
Subjects will intake placebo of Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
Subjects will intake placebo of Amoxicillin 500 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
Percentage of sites with marginal bleeding
Time frame: Baseline, 3, 6 and 12 months
Occurrence of headache obtained through a questionnaire of adverse effects
Time frame: 14 days after the beginning of treatments
Occurrence of vomiting obtained through a questionnaire of adverse effects
Time frame: 14 days after the beginning of treatments
Occurrence of diarrhea obtained through a questionnaire of adverse effects
Time frame: 14 days after the beginning of treatments
Occurrence of metallic taste obtained through a questionnaire of adverse effects
Time frame: 14 days after the beginning of treatments
Occurrence of nausea obtained through a questionnaire of adverse effects
Time frame: 14 days after the beginning of treatments
Occurrence of irritability obtained through a questionnaire of adverse effects
Time frame: 14 days after the beginning of treatments
Proportions of periodontal pathogenic bacterial species
Time frame: Baseline, 3, 6 and 12 months
Counts of periodontal pathogenic bacterial species
Time frame: Baseline, 3, 6 and 12 months