Clinical trial NCT02735395: Dose and Duration of Metronidazole and Amoxicillin for Treatment of Chronic Periodontitis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Periodontitis
Keywords: Periodontal Diseases
Metronidazole
Amoxicillin
Chronic periodontitis
Root Planing
Lead sponsor: University of Guarulhos
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Number of sites with PD ≥ 5 mm
timeFrame: Baseline, 3, 6 and 12 months
measure: Number of sites with PD ≥ 6 mm
timeFrame: Baseline, 3, 6 and 12 months
measure: Number of sites with PD ≥ 7 mm
timeFrame: Baseline, 3, 6 and 12 months
measure: Reduction in the number of sites with PD ≥ 5 mm
timeFrame: Baseline, 3, 6 and 12 months
measure: Reduction in the number of sites with PD ≥ 6 mm
timeFrame: Baseline, 3, 6 and 12 months
measure: Reduction in the number of sites with PD ≥ 7 mm
timeFrame: Baseline, 3, 6 and 12 months
measure: Full-mouth PD
timeFrame: Baseline, 3, 6 and 12 months
measure: Full-mouth clinical attachment level
timeFrame: Baseline, 3, 6 and 12 months
measure: Percentage of sites with bleeding on probing
timeFrame: Baseline, 3, 6 and 12 months
measure: Percentage of sites with plaque accumulation
timeFrame: Baseline, 3, 6 and 12 months
measure: Percentage of sites with marginal bleeding
timeFrame: Baseline, 3, 6 and 12 months
measure: Occurrence of headache obtained through a questionnaire of adverse effects
timeFrame: 14 days after the beginning of treatments
measure: Occurrence of vomiting obtained through a questionnaire of adverse effects
timeFrame: 14 days after the beginning of treatments
measure: Occurrence of diarrhea obtained through a questionnaire of adverse effects
timeFrame: 14 days after the beginning of treatments
measure: Occurrence of metallic taste obtained through a questionnaire of adverse effects
timeFrame: 14 days after the beginning of treatments
measure: Occurrence of nausea obtained through a questionnaire of adverse effects
timeFrame: 14 days after the beginning of treatments
measure: Occurrence of irritability obtained through a questionnaire of adverse effects
timeFrame: 14 days after the beginning of treatments
measure: Proportions of periodontal pathogenic bacterial species
timeFrame: Baseline, 3, 6 and 12 months
measure: Counts of periodontal pathogenic bacterial species
timeFrame: Baseline, 3, 6 and 12 months
Other outcomes:
Locations:
city: Guarulhos
country: Brazil
facility: Guarulhos University
state: São Paulo
Study officials:
affiliation: Guarulhos University
name: Magda Feres, Professor
role: STUDY_CHAIR
References:
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