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Clinical Trials/NCT01271231
NCT01271231
Completed
Not Applicable

Effects of Periodontal Treatment on Clinical Parameters and Glucose Metabolism in Diabetic Patients

Universidad de Antioquia1 site in 1 country90 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Scaling and root planing plus placebo
Conditions
Diabetes
Sponsor
Universidad de Antioquia
Enrollment
90
Locations
1
Primary Endpoint
Glycated hemoglobin
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Diabetes is a metabolic disorder that affects the uptake of glucose into cells. This causes a cascade of systemic alterations that may lead to kidney failure, cardiovascular complications, altered tissue healing, retinopathies and gangrene. Diabetes is also associated to increased susceptibility to infections and inflammation.

It has been observed that diabetic patients suffer more often from oral infections such as periodontal disease. Periodontal disease is an infectious-inflammatory disease that leads to destruction of the surrounding tissues of the tooth. It is proposed that the mechanisms responsible for systemic complication are implicated in the development of periodontal disease. This has been evaluated in studies where diabetic patients showed increased levels of inflammatory cytokines, subgingival bacteria and limited response to treatment. Its has also been suggested that established periodontitis in the diabetic patient leads to insulin resistance due to infection and liberation of cytokines from periodontal tissues and thus worsening the diabetic condition.

This study is aimed to establish the response to periodontal treatment with antibiotics and the kinetics of glucose levels in diabetic patients.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
October 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Javier Enrique Botero

Assistant Professor

Universidad de Antioquia

Eligibility Criteria

Inclusion Criteria

  • Must be of legal age (≥18 years old).
  • Voluntary participation and signed informed consent.
  • Confirmed type I and II diabetes.
  • At least 10 teeth present in mouth.

Exclusion Criteria

  • pregnant women.
  • Antibiotic consumption 3 months before inclusion.
  • HIV positive or AIDS.
  • Allergic reactions to macrolides and specifically to azythromycin.
  • Periodontal treatment 6 months before inclusion.

Arms & Interventions

Group IP1

Intervention: Scaling and root planing plus placebo

Group IP2

Intervention: Scaling and root planing plus azythromycin

Group IP3

Intervention: Prophylaxis plus azythromycin

Outcomes

Primary Outcomes

Glycated hemoglobin

Time Frame: 1 year

Secondary Outcomes

  • Probing depth(1 year)
  • Bleeding on probing(1 year)
  • Clinical attachment level(1 year)
  • Plaque index(1 year)
  • Glycemia(1 year)

Study Sites (1)

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