Diagnostic Biomarkers Related to Periodontal Disease Activity in Diabetic

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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) associated or not with type 2 diabetes mellitus (DM), based on the evaluation of the profile of gene expression of periodontal sites and the evaluation of inflammatory salivary proteins. Two hundred and five periodontal patients were enrolled, but only 41 exhibited ≥ 1 mm attachment loss in at least three periodontal site (active sites) 2 months after non-surgical periodontal therapy. The final sample was: 21 patients with chronic periodontitis (PD group) and 20 with chronic periodontitis and diabetes (PD+DM group). Fifteen periodontal- and systemically healthy patients were included as control group. Saliva collection, glycated hemoglobin measurement, periodontal examination and radiographs were conducted before and 2 months after non-surgical periodontal therapy. Radiographic subtraction was performed from pairs of the radiographs. Measurements of the areas with density loss were recorded. Gingival biopsies of active and non-active sites with similar clinical parameters were harvested for Real Time Polymerase Chain Reaction Array gene expression analysis. Saliva samples were analyzed by Multiplex Cytokine Profiling Immunoassay for analysis of protein expression. The clinical attachment loss mean was higher in the PD+DM group (p<0.05). There was a high correlation between clinical attachment loss and darkened radiographic areas in active sites of the PD group and PD+DM group. When compared PD group to PD+DM, patients with diabetes had an up-regulated profile. Active sites of the PD group showed nine genes (specific chemokines, interleukins and receptors) differentially expressed with an up-regulated profile. Active sites of the PD+DM group showed six genes (specific chemokines, interleukins and receptors) differentially expressed with an up-regulated profile. After periodontal therapy, there was a reduction of some salivary proteins in both periodontal groups, but not significant. In conclusion, it was possible to identify genes differentially expressed in active sites from both groups, which may be considered useful in indicating potential biomarkers for the diagnosis of periodontitis; salivary proteins show a trend in distinguishing the standard of health and disease and may be used in the future as potential biomarkers of periodontitis with or without diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Doxycycline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.