Chronic Periodontitis
Conditions
Keywords
Periodontal Diseases, Metronidazole, Amoxicillin, Chronic periodontitis, Root Planing
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.
Interventions
PROCEDUREScaling and root planing (SRP)
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.
DRUGMetronidazole 250 (7 days)
Subjects will intake Metronidazole 250 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.
DRUGMetronidazole 400 (7 days)
Subjects will intake Metronidazole 400 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.
DRUGMetronidazole 250 (14 days)
Subjects will intake Metronidazole 250 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
DRUGMetronidazole 400 (14 days)
Subjects will intake Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
DRUGAmoxicillin
Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.
OTHERPlacebo 250 (7 days)
Subjects will intake placebo of Metronidazole 250 mg. for 7 days, starting immediately after to intake Metronidazole 250 mg.
OTHERPlacebo 400 (7 days)
Subjects will intake placebo of Metronidazole 400 mg. for 7 days, starting immediately after to intake Metronidazole 400 mg.
OTHERPlacebo 400 (14 days)
Subjects will intake placebo of Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
OTHERPlacebo 500
Subjects will intake placebo of Amoxicillin 500 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
Sponsors
University of Guarulhos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of sites with PD ≥ 5 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 |
| Percentage of sites with plaque accumulation | Baseline, 3, 6 and 12 months |
| Number of sites with PD ≥ 6 mm | Baseline, 3, 6 and 12 months |
| Occurrence of headache obtained through a questionnaire of adverse effects | 14 days after the beginning of treatments |
| 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 |
| Percentage of sites with marginal bleeding | Baseline, 3, 6 and 12 months |
Countries
Brazil
Outcome results
None listed