Clinical Trial: Dose and Duration of Metronidazole and Amoxicillin for Treatment of Chronic Periodontitis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Impact of Different Dosages and Time of Administration of Metronidazole and Amoxicillin in the Treatment of Generalized Chronic Periodontitis: A Randomized Clinical Trial
Brief Summary: 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).
Detailed Summary: 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.
Sponsor: University of Guarulhos
Current Primary Outcome: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
- 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 ]
Original Secondary Outcome: Same as current
Information By: University of Guarulhos
Dates:
Date Received: March 22, 2016
Date Started: July 2011
Date Completion: September 2018
Last Updated: May 17, 2017
Last Verified: May 2017
