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Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis

NCT02135952 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-05-12

No results posted yet for this study

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.

Conditions

  • Periodontitis

Interventions

PROCEDURE

SRP

SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.

OTHER

Placebo

Administration of placebo for 14 days started immediately after the first session of SRP.

DRUG

MTZ+AMX

Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.

Sponsors & Collaborators

  • University of Guarulhos

    lead OTHER

Principal Investigators

  • Poliana M Duarte, PhG · University of Guarulhos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02135952 on ClinicalTrials.gov