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

Sponsors

Lead Sponsor: Eduardo Aleixo Figueira

Collaborator: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Source Universidade Federal do Rio Grande do Norte
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.

Overall Status Unknown status
Start Date January 2013
Completion Date October 2017
Primary Completion Date October 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of bleeding on probing Baseline
Percentage of bleeding on probing at three months
Percentage of bleeding on probing at six months
Percentage of bleeding on probing at nine months
Percentage of bleeding on probing at twelve months
Percentage of bleeding on probing at eighteen months
Percentage of bleeding on probing at twenty four months
Secondary Outcome
Measure Time Frame
Percentage of visible plaque index Baseline and at three, six, nine, twelve, eighteen and twenty four months
Probing depth (mm) Baseline and at three, six, nine, twelve, eighteen and twenty four months
Clinical attachment level (mm) Baseline and at three, six, nine, twelve, eighteen and twenty four months
Enrollment 144
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Full Mouth Scaling and Root Planing

Description: This procedure was performed as described by Quirynen et al. 2005 with some modifications

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Bruno CV Gurgel, Doctor Principal Investigator Universidade Federal do Rio Grande do Norte
Overall Contact

Last Name: Bruno CV Gurgel, Doctor

Phone: +558432154136

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Departamento de Odontologia; Universidade Federal do Rio Grande do Norte Bruno CV Gurgel, Doctor +558432154136 [email protected]
Location Countries

Brazil

Verification Date

December 2015

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Universidade Federal do Rio Grande do Norte

Investigator Full Name: Eduardo Aleixo Figueira

Investigator Title: DDS, MSc, PhD, Post-Doctoral Student

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Diabetic group

Type: Experimental

Description: Subjects with Chronic Periodontitis and Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)

Label: Nondiabetic group

Type: Experimental

Description: Subjects with Chronic Periodontitis and without Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov