Overview

This trial is active, not recruiting.

Condition periodontitis
Treatments srp, placebo, mtz+amx
Phase phase 4
Sponsor University of Guarulhos
Start date September 2011
End date October 2014
Trial size 58 participants
Trial identifier NCT02135952, 2013/01072-5, SISNEP/697

Summary

Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic and oral complications, such as periodontitis. The use of adjunctive local and/or systemic antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ) and amoxicillin (AMX) has been largely recognized as an effective therapy for improving the clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis (ChP). However, no previous clinical trials to date have evaluated the effects of this antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore, the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2 diabetic subjects with generalized ChP.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Scaling and root planing (SRP) + metronidazole (MTZ; 400 mg thrice a day [TID] for 14 days) + amoxicillin (AMX; 500 mg TID for 14 days)
srp
SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.
mtz+amx
Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.
(Placebo Comparator)
Scaling and root planing + placebo
srp
SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.
placebo
Administration of placebo for 14 days started immediately after the first session of SRP.

Primary Outcomes

Measure
Changes in number of sites with probing depth (PD) ≥5 mm post-treatment
time frame: From baseline to 12 months

Secondary Outcomes

Measure
PD and clinical attachment level (CAL) changes at initially moderate sites
time frame: From baseline to 12 months and from baseline to 24 months
PD and CAL changes at initially deep sites
time frame: From baseline to 12 months and from baseline to 24 months
Changes in number of sites with PD ≥5mm
time frame: From baseline to 12 months and from baseline to 24 months
Full-mouth PD and CAL
time frame: Baseline, 3, 6, 12 and 24 months
Full-mouth percentages of sites with plaque
time frame: Baseline, 3, 6, 12 and 24 months
Full-mouth percentages of sites with marginal bleeding
time frame: Baseline, 3, 6, 12 and 24 months
Full-mouth percentages of sites with bleeding on probing
time frame: Baseline, 3, 6, 12 and 24 months
Full-mouth percentages of sites with suppuration
time frame: Baseline, 3, 6, 12 and 24 months
Full-mouth percentages of sites with PD ≥5mm
time frame: Baseline, 3, 6,12 and 24 months
Serum levels of glycated hemoglobin (HbA1c)
time frame: Baseline, 3, 6, 12 and 24 months
Serum levels of fasting plasma glucose FPG
time frame: Baseline, 3, 6, 12 and 24 months
Levels of periodontal pathogenic bacterial species
time frame: Baseline, 3, 6, 12 and 24 months
Occurrence of adverse events
time frame: 14 days

Eligibility Criteria

Male or female participants at least 35 years old.

Inclusion Criteria: - ≥ 35 years of age - Diagnosis of type 2 DM for ≥ 5 years - DM treatment with diet and insulin supplementation or oral hypoglycemic agents - Glycated hemoglobin (HbA1c) levels ≥ 6.5% ≤ 11% - At least 15 teeth - More than 30% of the sites with probing depth (PD) and clinical attachment level (CAL) ≥ 4 mm - Minimum of six teeth with at least one site with PD and CAL ≥ 5 mm and bleeding on probing (BoP) at baseline. Exclusion Criteria: - Pregnancy - Lactation - Current smoking - Smoking within the past 5 years - Scaling and root planing (SRP) in the previous 12 months - Antimicrobial therapies during the previous 6 months - Medical conditions requiring prophylactic antibiotic coverage - Continuous use of mouthrinses containing antimicrobials in the preceding 3 months - Systemic conditions (except DM) that could affect the progression of periodontitis (e.g. immunological disorders, osteoporosis) - Long-term administration of anti-inflammatory - Long-term administration of immunosuppressive medications - Allergy to metronidazole and/or amoxicillin - Presence of periapical pathology - Use of orthodontic appliances - Presence of extensive prosthetic rehabilitation - Major complications of DM (i.e. cardiovascular and peripheral vascular diseases [ulcers, gangrene and amputation], neuropathy and nephropathy)

Additional Information

Official title Metronidazole and Amoxicillin as Adjuncts to Scaling and Root Planing for the Treatment of Type 2 Diabetic Subjects With Periodontitis: a Randomized Placebo-controlled Clinical Trial
Principal investigator Poliana M Duarte, PhG
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of Guarulhos.