Study on Periodontal Treatment in Diabetic Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Gingivitis, Periodontitis

Intervention / Treatment
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* Drug: Scaling and root planing plus placebo
* Drug: Scaling and root planing plus azythromycin
* Drug: Prophylaxis plus azythromycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group IP1<br> | Drug: Scaling and root planing plus placebo<br>* Single session of scaling and root planing using ultrasonic device. placebo tablets 500 mg, 1 tablet every 24 hours for 3 days<br>|
| Experimental: Group IP2<br> | Drug: Scaling and root planing plus azythromycin<br>* Single session of scaling and root planing using ultrasonic device. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.<br>|
| Active Comparator: Group IP3<br> | Drug: Prophylaxis plus azythromycin<br>* Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing | A sign of gingival inflammation | 1 year | 
| Clinical attachment level |  | 1 year | 
| Plaque index |  | 1 year | 
| Glycemia |  | 1 year | 
| Probing depth |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontal treatment, diabetes, glycemia, glycated hemoglobin