Dose and Duration of Metronidazole and Amoxicillin for Treatment of Chronic Periodontitis
- Conditions
- Chronic Periodontitis
- Interventions
- Procedure: Scaling and root planing (SRP)Other: Placebo 400 (14 days)Other: Placebo 500Other: Placebo 250 (7 days)Other: Placebo 400 (7 days)
- Registration Number
- NCT02735395
- Lead Sponsor
- University of Guarulhos
- 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 Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- ≥30 years of age;
- at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
- a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical * attachment level (CAL) ≥5 mm;
- at least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).
- pregnancy
- breastfeeding
- current smoking and former smoking within the past 5 years;
- systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
- scaling and root planing an in the previous 12 months;
- antibiotic therapy in the previous 6 months;
- long-term intake of anti-inflammatory medications;
- need for antibiotic pre-medication for routine dental therapy;
- allergy to metronidazole and/or amoxicillin.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Scaling and root planing (SRP) Scaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group) Control Placebo 400 (14 days) Scaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group) Control Placebo 500 Scaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group) MTZ 250 (7 days) Scaling and root planing (SRP) SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days MTZ 250 (7 days) Metronidazole 250 (7 days) SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days MTZ 400 (7 days) Metronidazole 400 (7 days) SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days MTZ 250 (14 days) Metronidazole 250 (14 days) SRP +MTZ (250mg/TID) + AMX for 14 days MTZ 400 (14 days) Scaling and root planing (SRP) SRP +MTZ (400mg/TID) + AMX for 14 days MTZ 400 (14 days) Metronidazole 400 (14 days) SRP +MTZ (400mg/TID) + AMX for 14 days MTZ 250 (7 days) Placebo 250 (7 days) SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days MTZ 400 (7 days) Scaling and root planing (SRP) SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days MTZ 400 (7 days) Placebo 400 (7 days) SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days MTZ 250 (14 days) Scaling and root planing (SRP) SRP +MTZ (250mg/TID) + AMX for 14 days MTZ 250 (7 days) Amoxicillin SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days MTZ 400 (7 days) Amoxicillin SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days MTZ 400 (14 days) Amoxicillin SRP +MTZ (400mg/TID) + AMX for 14 days MTZ 250 (14 days) Amoxicillin SRP +MTZ (250mg/TID) + AMX for 14 days
- Primary Outcome Measures
Name Time Method Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months 12 months
- Secondary Outcome Measures
Name Time Method Percentage of sites with plaque accumulation Baseline, 3, 6 and 12 months Percentage of sites with marginal bleeding Baseline, 3, 6 and 12 months Occurrence of headache obtained through a questionnaire of adverse effects 14 days after the beginning of treatments Number of sites with PD ≥ 5 mm Baseline, 3, 6 and 12 months Occurrence of vomiting obtained through a questionnaire of adverse effects 14 days after the beginning of treatments Occurrence of diarrhea obtained through a questionnaire of adverse effects 14 days after the beginning of treatments Occurrence of metallic taste obtained through a questionnaire of adverse effects 14 days after the beginning of treatments Occurrence of nausea obtained through a questionnaire of adverse effects 14 days after the beginning of treatments Occurrence of irritability obtained through a questionnaire of adverse effects 14 days after the beginning of treatments Proportions of periodontal pathogenic bacterial species Baseline, 3, 6 and 12 months Counts of periodontal pathogenic bacterial species Baseline, 3, 6 and 12 months Number of sites with PD ≥ 6 mm Baseline, 3, 6 and 12 months Number of sites with PD ≥ 7 mm Baseline, 3, 6 and 12 months Reduction in the number of sites with PD ≥ 5 mm Baseline, 3, 6 and 12 months Reduction in the number of sites with PD ≥ 6 mm Baseline, 3, 6 and 12 months Reduction in the number of sites with PD ≥ 7 mm Baseline, 3, 6 and 12 months Full-mouth PD Baseline, 3, 6 and 12 months Full-mouth clinical attachment level Baseline, 3, 6 and 12 months Percentage of sites with bleeding on probing Baseline, 3, 6 and 12 months
Trial Locations
- Locations (1)
Guarulhos University
🇧🇷Guarulhos, São Paulo, Brazil