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
  Purpose

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.


Condition Intervention
Diabetes
Gingivitis
Periodontitis
Drug: Scaling and root planing plus placebo
Drug: Scaling and root planing plus azythromycin
Drug: Prophylaxis plus azythromycin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Periodontal Treatment on Clinical Parameters and Glucose Metabolism in Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:
  • Glycated hemoglobin [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: April 2010
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group IP1 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
Experimental: Group IP2 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.
Active Comparator: Group IP3 Drug: Prophylaxis plus azythromycin
Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271231

Locations
Colombia
Universidad de Antioquia, School of dentistry
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Colgate Palmolive
Investigators
Study Director: Javier E Botero, PhD Universidad de Antioquia, School of dentistry
Principal Investigator: Fanny L Yepes, DDS Universidad de Antioquia, School of dentistry
  More Information

Publications:

Responsible Party: Javier Enrique Botero, Assistant Professor, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01271231     History of Changes
Other Study ID Numbers: 020-2009
Study First Received: January 5, 2011
Last Updated: May 28, 2013
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad de Antioquia:
periodontal treatment, diabetes, glycemia, glycated hemoglobin

Additional relevant MeSH terms:
Diabetes Mellitus
Gingivitis
Periodontitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014