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Completed

NCT Number: NCT01271231

Study on Periodontal Treatment in Diabetic Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Antioquia, School of dentistry

Medellín, Antioquia, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Smokers.
  • 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.

Treatment and study plan

Scaling and root planing plus placebo

Drug

Single session of scaling and root planing using ultrasonic device. placebo tablets 500 mg, 1 tablet every 24 hours for 3 days

Scaling and root planing plus azythromycin

Drug

Single session of scaling and root planing using ultrasonic device. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.

Prophylaxis plus azythromycin

Drug

Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.

Primary outcomes

  1. Glycated hemoglobin

    Time frame: 1 year

Secondary outcomes

  1. Bleeding on probing

    Time frame: 1 year

    A sign of gingival inflammation

  2. Clinical attachment level

    Time frame: 1 year

  3. Plaque index

    Time frame: 1 year

  4. Glycemia

    Time frame: 1 year

  5. Probing depth

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Collaborators

  • Colgate Palmolive

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2011
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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