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

December 30, 2015 updated by: Eduardo Aleixo Figueira

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59056-000
        • Recruiting
        • Departamento de Odontologia; Universidade Federal do Rio Grande do Norte
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetic group
Subjects with Chronic Periodontitis and Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)
Procedure: Full Mouth Scaling and Root Planing
This procedure was performed as described by Quirynen et al. 2005 with some modifications
Experimental: Nondiabetic group
Subjects with Chronic Periodontitis and without Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)
Procedure: Full Mouth Scaling and Root Planing
This procedure was performed as described by Quirynen et al. 2005 with some modifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of bleeding on probing
Time Frame: Baseline
The mean percentage of periodontal sites with bleeding on probing
Baseline
Percentage of bleeding on probing
Time Frame: at three months
The mean percentage of periodontal sites with bleeding on probing
at three months
Percentage of bleeding on probing
Time Frame: at six months
The mean percentage of periodontal sites with bleeding on probing
at six months
Percentage of bleeding on probing
Time Frame: at nine months
The mean percentage of periodontal sites with bleeding on probing
at nine months
Percentage of bleeding on probing
Time Frame: at twelve months
The mean percentage of periodontal sites with bleeding on probing
at twelve months
Percentage of bleeding on probing
Time Frame: at eighteen months
The mean percentage of periodontal sites with bleeding on probing
at eighteen months
Percentage of bleeding on probing
Time Frame: at twenty four months
The mean percentage of periodontal sites with bleeding on probing
at twenty four months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eduardo Aleixo Figueira

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

  • Principal Investigator: Bruno CV Gurgel, Doctor, Universidade Federal do Rio Grande do Norte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1175-5481

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Full Mouth Scaling and Root Planing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe