NCT02643771

Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study

Clinical and Microbiological Evaluation of Non-surgical Periodontal Treatment of Diabetic and Non-diabetic Patients: A Longitudinal Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Eduardo Aleixo Figueira · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether periodontal treatment improves the periodontal clinical parameters in the periodontal patients with diabetes regarding non-diabetics: two years follow-up.

Detailed description

All the subjects in the study will receive non surgical periodontal treatment in one session (full-mouth scaling and root planing). Clinical parameters will be assessed in all teeth (except third molars) by one experienced and trained examiner before treatment and every 3 months for 2 years. Visible plaque index (VPI) will be represented a mean percentage of sites with visible plaque calculated for all teeth analyzed (four sites per tooth). Others parameters will be assessed at six sites per tooth using a manual periodontal probe (15mm). Bleeding on probing (BOP) will be represented the mean percentage of sites with bleeding (up to 15 seconds after probing) calculated for all teeth analyzed. Probing depth (PD - distance between the gingival margin and the bottom of the sulcus/pocket), gingival recession (GR - distance between the cementoenamel junction and gingival margin) and clinical attachment level (CAL - distance between the cementoenamel junction and the bottom of the sulcus/pocket) will be represented a mean distance calculated per site for all teeth analyzed. For blood parameters, an outside laboratory will perform all blood analysis. It will be requested for each subject with diabetes (DG) at baseline, each 3 months post-treatment. Fasting plasma glucose (FPG) will be expressed in milligrams per deciliter and HbA1c will be expressed as a percentage. Statistical analysis will be performed using an available software program and the patient will be considered as the unit of analysis.The data will be processed and analyzed by descriptive and inferential statistics, probably nonparametric.

Conditions

• Chronic Periodontitis
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
PROCEDURE	Full Mouth Scaling and Root Planing	This procedure was performed as described by Quirynen et al. 2005 with some modifications

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-10-01
• Completion: 2017-10-01
• First posted: 2015-12-31
• Last updated: 2015-12-31

Locations

1 site across 1 country: Brazil