Diabetes, Gingivitis, Periodontitis
Conditions
Keywords
periodontal treatment, diabetes, glycemia, glycated hemoglobin
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.
Interventions
Single session of scaling and root planing using ultrasonic device. placebo tablets 500 mg, 1 tablet every 24 hours for 3 days
DRUGScaling 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.
DRUGProphylaxis plus azythromycin
Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
Sponsors
Colgate Palmolive
Universidad de Antioquia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemia | 1 year | — |
| Probing depth | 1 year | — |
| Bleeding on probing | 1 year | A sign of gingival inflammation |
| Clinical attachment level | 1 year | — |
| Plaque index | 1 year | — |
Countries
Colombia
Outcome results
None listed