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

Phase 2

• Conditions: Chronic Periodontitis; Diabetes Mellitus, Type 2

• Registration Number: NCT02643771
• Lead Sponsor: Eduardo Aleixo Figueira

Brief 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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2015-12
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-30
• Last Update Submitted: 2015-12-30
• Study First Posted: 2015-12-31
• Last Update Posted: 2015-12-31
• Primary Completion: 2016-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Clinical diagnosis of chronical periodontitis according to Lopez et al. 2002 (one or more teeth with at least one site with PD >= 4mm or CAL >= 3mm);
• And have at least 8 natural teeth (excluding third molars), and older than 18 years and of both genders.

Exclusion Criteria

• Any systemic diseases or complications (except Type 2 Diabetes Mellitus) such as cardiovascular disease, Alzheimer's, lung or brain diseases and metabolic syndrome;
• Use of antibiotics or periodontal treatment within the past 6 months;
• Long-term administration of anti-inflammatory or/and immunosuppressive agents;
• Current smoker or former smoker for the past 5 years;
• Pregnant or breastfeeding;
• And presence of orthodontic appliances.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of bleeding on probing	at twenty four months	The mean percentage of periodontal sites with bleeding on probing

Secondary Outcome Measures

Name	Time	Method
Probing depth (mm)	Baseline and at three, six, nine, twelve, eighteen and twenty four months	The mean of probing depth in millimeters calculated for periodontal sites.
Percentage of visible plaque index	Baseline and at three, six, nine, twelve, eighteen and twenty four months	The mean percentage of periodontal sites with visible plaque
Clinical attachment level (mm)	Baseline and at three, six, nine, twelve, eighteen and twenty four months	The mean of clinical attachment level in millimeters calculated for periodontal sites.

Trial Locations

Locations (1)

Departamento de Odontologia; Universidade Federal do Rio Grande do Norte; 🇧🇷 Natal, Rio Grande do Norte, Brazil