Clinical trial NCT01271231: Study on Periodontal Treatment in Diabetic Patients
Official title: Effects of Periodontal Treatment on Clinical Parameters and Glucose Metabolism in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Gingivitis
Periodontitis
Keywords: periodontal treatment, diabetes, glycemia, glycated hemoglobin
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2011-01-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 1 year
Secondary outcomes:
measure: Bleeding on probing
timeFrame: 1 year
measure: Clinical attachment level
timeFrame: 1 year
measure: Plaque index
timeFrame: 1 year
measure: Glycemia
timeFrame: 1 year
measure: Probing depth
timeFrame: 1 year
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Universidad de Antioquia, School of dentistry
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia, School of dentistry
name: Javier E Botero, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Antioquia, School of dentistry
name: Fanny L Yepes, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Madden TE, Herriges B, Boyd LD, Laughlin G, Chiodo G, Rosenstein D. Alterations in HbA1c following minimal or enhanced non-surgical, non-antibiotic treatment of gingivitis or mild periodontitis in type 2 diabetic patients: a pilot trial. J Contemp Dent Pract. 2008 Jul 1;9(5):9-16.
citation: Ernst EJ, Klepser ME, Klepser TB, Nightingale CH, Hunsicker LG. Comparison of the serum and intracellular pharmacokinetics of azithromycin in healthy and diabetic volunteers. Pharmacotherapy. 2000 Jun;20(6):657-61. doi: 10.1592/phco.20.7.657.35176.