Study on Periodontal Treatment in Diabetic Patients

Universidad de Antioquia

Status: Completed

Conditions: Periodontitis; Diabetes; Gingivitis

Treatments: Drug: Scaling and root planing plus placebo; Drug: Scaling and root planing plus azythromycin; Drug: Prophylaxis plus azythromycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01271231

020-2009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Group IP1

Placebo Comparator group

Treatment:

Drug: Scaling and root planing plus placebo

Group IP2

Experimental group

Treatment:

Drug: Scaling and root planing plus azythromycin

Group IP3

Active Comparator group

Treatment:

Drug: Prophylaxis plus azythromycin