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

May 6, 2014 updated by: Poliana Mendes Duarte, University of Guarulhos

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Guarulhos, São Paulo, Brazil, 07023-070
        • University of Guarulhos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SRP+MTZ+AMX
Scaling and root planing (SRP) + metronidazole (MTZ; 400 mg thrice a day [TID] for 14 days) + amoxicillin (AMX; 500 mg TID for 14 days)
Procedure: SRP
SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.
Drug: MTZ+AMX
Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.
Placebo Comparator: SRP+placebo
Scaling and root planing + placebo
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guarulhos

Investigators

  • Principal Investigator: Poliana M Duarte, PhG, University of Guarulhos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SISNEP/697
  • 2013/01072-5 (Other Grant/Funding Number: FAPESP - 2013/01072-5)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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