The aim of this multicenter randomized clinical trial is to compare the clinical, microbiological and immunological effects of the adjunctive use of systemic metronidazole plus amoxicillin administered in different phases of the treatment of generalized chronic periodontitis.
The combination of systemic metronidazole (MTZ) and amoxicillin (AMX) to scaling and root planing (SRP) has shown to be a promising periodontal treatment. However, some essential issues associated with the use of these antibiotics remain to be established. Although these agents are often prescribed after the healing phase of the SRP procedure, there is biological plausibility to support its use in conjunction with the mechanical treatment. However, to date, no placebo controlled randomized clinical trial (RCT) has directly compared these two protocols. Therefore, the aim of this multicentric RCT is to compare the clinical, microbiological and immunological effects of adjunctive systemic MTZ+AMX administered in different phases of the treatment of generalized chronic periodontitis (GChP). 180 subjects with GChP will be randomly assigned into three groups (n=60/group) that will receive SRP-only (control group) or in combination with 400 mg MTZ+500 mg AMX beginning at the first SRP session (group test 1) or after 3 months of its completion (group test 2). All volunteers will receive clinical and microbiological evaluation at baseline, 3, 6 and 12 months, and immunological assessment (levels of 20 chemokines) at baseline and 12 months post-therapy. Nine subgingival biofilm samples will be collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization. Differences in clinical, microbiological and immunological parameters among groups and over time will be evaluated using the ANOVA, ANCOVA, Chi-square and Tukey tests. Microbiological analyzes will be performed using adjustments for multiple comparisons. Statistical significance will be set at 5%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
SRP will be 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.
Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).
Metronidazole 400 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).
University of Guarulhos
Guarulhos, São Paulo, Brazil
University of São Paulo
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.
Mean PD changes in sites with initial PD between 4-6 mm
Time frame: Baseline - 12 months.
Mean PD changes in sites with initial PD ≥ 7 mm.
Time frame: Baseline - 12 months.
Mean CAL changes in sites with initial CAL between 4-6 mm
Time frame: Baseline - 12 months.
Mean CAL changes in sites with initial CAL ≥ 7 mm.
Time frame: Baseline - 12 months.
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Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).
Amoxicillin 500 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).
Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session).
Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase).
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.
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 taking antibiotic.
Occurrence of vomiting obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of metallic taste obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of nausea obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
Occurrence of irritability obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic.
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.
Counts of chemokines in the crevicular gingival fluid.
Time frame: Baseline and 12 months.