Study on Periodontal Treatment in Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT01271231|
Recruitment Status : Completed
First Posted : January 6, 2011
Last Update Posted : May 29, 2013
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 or disease||Intervention/treatment||Phase|
|Diabetes Gingivitis Periodontitis||Drug: Scaling and root planing plus placebo Drug: Scaling and root planing plus azythromycin Drug: Prophylaxis plus azythromycin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effects of Periodontal Treatment on Clinical Parameters and Glucose Metabolism in Diabetic Patients|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||October 2012|
|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.
- Glycated hemoglobin [ Time Frame: 1 year ]
- Bleeding on probing [ Time Frame: 1 year ]A sign of gingival inflammation
- Clinical attachment level [ Time Frame: 1 year ]
- Plaque index [ Time Frame: 1 year ]
- Glycemia [ Time Frame: 1 year ]
- Probing depth [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271231
|Universidad de Antioquia, School of dentistry|
|Medellin, Antioquia, Colombia|
|Study Director:||Javier E Botero, PhD||Universidad de Antioquia, School of dentistry|
|Principal Investigator:||Fanny L Yepes, DDS||Universidad de Antioquia, School of dentistry|