Status:
COMPLETED
Diagnostic Biomarkers Related to Periodontal Disease Activity in Diabetic
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Periodontitis
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study was to monitor the activity of periodontal disease and suggest potential biomarkers related to active periodontal disease in patients with chronic periodontitis (PD) associate...
Detailed Description
This case-control longitudinal study was carried out at University of São Paulo between March 2009 and June 2012 as a joint collaboration of the Department of Oral Surgery and Periodontology and the D...
Eligibility Criteria
Inclusion
- adults aged between 35 to 65 years old;
- a minimum of 14 natural teeth, 10 of which should be posterior teeth;
- periodontitis case definition was the presence of five teeth with a probing pocket depth of ≥ 5 mm and clinical attachment loss of ≥ 3 mm;
- type 2 diabetes for at least 5 years and with glycated hemoglobin level \> 7%.
Exclusion
- smoking within the last 5 years;
- pregnancy or lactating;
- use of antibiotics or periodontal therapy in the previous six months;
- concomitant medical therapy, except for diabetic condition;
- other inflammatory conditions;
- major diabetic complications such as retinopathy, nephropathy, neuropathy and atherosclerosis.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02220751
Start Date
March 1 2009
End Date
June 1 2012
Last Update
August 20 2014
Active Locations (1)
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1
Mario Taba Jr
Ribeirão Preto, São Paulo, Brazil, 14040-904