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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Guarulhos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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