Study on Periodontal Treatment in Diabetic Patients

Not Applicable

Completed

• Conditions: Diabetes; Gingivitis; Periodontitis
• Interventions: Drug: Scaling and root planing plus placebo; Drug: Scaling and root planing plus azythromycin; Drug: Prophylaxis plus azythromycin

• Registration Number: NCT01271231
• Lead Sponsor: Universidad de Antioquia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-06
• Primary Completion: 2012-07
• Study Completion: 2012-10
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group IP1	Scaling and root planing plus placebo	-
Group IP2	Scaling and root planing plus azythromycin	-
Group IP3	Prophylaxis plus azythromycin	-

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin	1 year

Secondary Outcome Measures

Name	Time	Method
Probing depth	1 year
Bleeding on probing	1 year	A sign of gingival inflammation
Clinical attachment level	1 year
Plaque index	1 year
Glycemia	1 year

Trial Locations

Locations (1)

Universidad de Antioquia, School of dentistry; 🇨🇴 Medellin, Antioquia, Colombia