Overview

This trial is active, not recruiting.

Condition chronic periodontitis
Treatments scaling and root planing (srp), metronidazole 250 (7 days), metronidazole 400 (7 days), metronidazole 250 (14 days), metronidazole 400 (14 days), amoxicillin, placebo 250 (7 days), placebo 400 (7 days), placebo 400 (14 days), placebo 500
Phase phase 4
Sponsor University of Guarulhos
Start date July 2011
End date May 2014
Trial size 110 participants
Trial identifier NCT02735395, SISNEP/513

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Scaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group)
scaling 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.
placebo 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.
placebo 500
Subjects will intake placebo of Amoxicillin 500 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
(Active Comparator)
SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days
scaling 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.
metronidazole 250 (7 days)
Subjects will intake Metronidazole 250 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.
amoxicillin
Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.
placebo 250 (7 days)
Subjects will intake placebo of Metronidazole 250 mg. for 7 days, starting immediately after to intake Metronidazole 250 mg.
(Active Comparator)
SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days
scaling 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.
metronidazole 400 (7 days)
Subjects will intake Metronidazole 400 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.
amoxicillin
Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.
placebo 400 (7 days)
Subjects will intake placebo of Metronidazole 400 mg. for 7 days, starting immediately after to intake Metronidazole 400 mg.
(Active Comparator)
SRP +MTZ (250mg/TID) + AMX for 14 days
scaling 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.
metronidazole 250 (14 days)
Subjects will intake Metronidazole 250 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
amoxicillin
Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.
(Active Comparator)
SRP +MTZ (400mg/TID) + AMX for 14 days
scaling 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.
metronidazole 400 (14 days)
Subjects will intake Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
amoxicillin
Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.

Primary Outcomes

Measure
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
time frame: 12 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 30 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Guarulhos.