oxLDL in Diabetes Mellitus Patients and Disease Periodontal

November 11, 2018 updated by: Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho

Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients

Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters. 44 patients will be divided into 2 groups: Diabetic Patients with Chronic Periodontitis (DM2DP) and Diabetic Patients without Chronic Periodontitis (DM2). The DM2DP group will receive periodontal debridement and DM2 group will be treated with supragingival scaling. Both groups receive board control every 3 months. At baseline, 3 and 6 months after treatment, will be held making the clinical periodontal parameters (plaque index, gingival index, probing depth, gingival recession relative clinical attachment level and Periodontal Inflamed Surface Area (PISA) index) and blood collection for assessment serum inflammatory markers (oxLDL, LDL, HDL, total cholesterol, triglyceride, Interleukin (IL) IL-6, IL-8, IL-10, Tumor Necrosis Factor (TNF-α) and CRP). Biochemical analyzes will be carried out by Z-scan technique. The data obtained before and after periodontal therapy will be analyzed using the Shapiro-Wilk test.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Brazil
    • São Paulo
      • São Jose dos Campos, São Paulo, Brazil, 12245 000

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

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • individuals older than 35 years with DM2 diagnosed for more than five years and HbA1c between 7% and 11%;
  • be diagnosed with generalized chronic periodontitis: present at least 6 sites with periodontal pocket and loss of insertion above 5mm and two more bags with loss of insertion above 6mm;
  • present at least 20 teeth;
  • agree to participate in the study and sign the informed consent form

Exclusion Criteria:

  • patients with cardiovascular diseases, cancer, gastrointestinal disorders, skin diseases, pregnancy, lactation, smoking, arthritis, lupus or other diseases of inflammatory origin;
  • have undergone periodontal treatment in the last 12 months;
  • have made use of antioxidant supplements, anti-inflammatories, or antibiotics within the previous 3 months;
  • make use of medications that can alter the marking and concentration of oxLDL, for example, statins;
  • have changed the medication for glycemic control in the last 3 months;
  • present dental elements with pulpal or periapical inflammation.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Type 2 diabetes mellitus and periodontitis
periodontal debridement in a single session.
Procedure: Non-surgical periodontal treatment
Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .
No Intervention: Type 2 diabetes mellitus and without periodontitis
maintained every three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth change
Time Frame: baseline, 90 and 180 days
The change in the probing depth will be measure in millimeters before and after the treatment.
baseline, 90 and 180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxLDL concentration Change
Time Frame: baseline and 180 days
Change in concentration of oxLDL will be measured before and treatment.
baseline and 180 days
LDL, HDL, Total cholesterol, Triacylglycerol
Time Frame: baseline and 180 days
Blood concentration (g/ml) will be measured before and after periodontal therapy.
baseline and 180 days
Plaque index
Time Frame: baseline, 90 and 180 days
Number of teeth affected before and after periodontal treatment
baseline, 90 and 180 days
Gingival index
Time Frame: baseline, 90 and 180 days
number of teeth affected before and after periodontal treatment
baseline, 90 and 180 days
Gingival Recession
Time Frame: baseline, 90 and 180 days
Evaluated in millimeters before and after the treatment.
baseline, 90 and 180 days
Clinical Attachment Level
Time Frame: baseline, 90 and 180 days
Evaluated in millimeters before and after the treatment.
baseline, 90 and 180 days

Collaborators and Investigators

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

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Collaborators

LabviVale

Investigators

  • Study Director: Maria Jardini, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho

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 (Actual)

May 2, 2016

Primary Completion (Actual)

August 26, 2016

Study Completion (Actual)

January 28, 2017

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 11, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE:53785516.6.0000.0077

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

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.

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