Study on Periodontal Treatment in Diabetic Patients

This study has been completed.
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Javier Enrique Botero, Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT01271231
First received: January 5, 2011
Last updated: May 28, 2013
Last verified: May 2013

January 5, 2011
May 28, 2013
April 2010
July 2012   (final data collection date for primary outcome measure)
Glycated hemoglobin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Probing depth [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01271231 on ClinicalTrials.gov Archive Site
  • Bleeding on probing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A sign of gingival inflammation
  • Clinical attachment level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Plaque index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Glycemia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Probing depth [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Bleeding on probing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A sign of gingival inflammation
  • Clinical attachment level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Plaque index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Glycemia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Glycated hemoglobin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study on Periodontal Treatment in Diabetic Patients
Effects of Periodontal Treatment on Clinical Parameters and Glucose Metabolism 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes
  • Gingivitis
  • Periodontitis
  • Drug: Scaling and root planing plus placebo
    Single session of scaling and root planing using ultrasonic device. placebo tablets 500 mg, 1 tablet every 24 hours for 3 days
  • Drug: Scaling and root planing plus azythromycin
    Single session of scaling and root planing using ultrasonic device. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
  • Drug: Prophylaxis plus azythromycin
    Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
  • Placebo Comparator: Group IP1
    Intervention: Drug: Scaling and root planing plus placebo
  • Experimental: Group IP2
    Intervention: Drug: Scaling and root planing plus azythromycin
  • Active Comparator: Group IP3
    Intervention: Drug: Prophylaxis plus azythromycin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
October 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT01271231
020-2009
Not Provided
Javier Enrique Botero, Universidad de Antioquia
Universidad de Antioquia
Colgate Palmolive
Study Director: Javier E Botero, PhD Universidad de Antioquia, School of dentistry
Principal Investigator: Fanny L Yepes, DDS Universidad de Antioquia, School of dentistry
Universidad de Antioquia
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP