Effects of Periodontal Treatment on Clinical Parameters and Glucose Metabolism in Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Antioquia
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Glycated hemoglobin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Group IP1
Intervention: Scaling and root planing plus placebo (Drug)
Group IP2
Intervention: Scaling and root planing plus azythromycin (Drug)
Group IP3
Intervention: Prophylaxis plus azythromycin (Drug)
Outcomes
Primary Outcomes
Glycated hemoglobin
Time Frame: 1 year
Secondary Outcomes
- Probing depth(1 year)
- Bleeding on probing(1 year)
- Clinical attachment level(1 year)
- Plaque index(1 year)
- Glycemia(1 year)
Investigators
Javier Enrique Botero
Assistant Professor
Universidad de Antioquia