Periodontal Therapy in Coronary Artery Patients (PerioCardio)

September 26, 2019 updated by: Alex Nogueira Haas, Federal University of Rio Grande do Sul

Impact of Periodontal Therapy in Flow-mediated Dilation and Serum Levels of Cardiovascular Risk Biomarkers in Coronary Artery Disease Patients: 12 Months Randomized Controlled Trial

Gingival inflammation has been associated with cardiovascular diseases, including heart attack and stroke, because of elevation of blood risk markers such as cholesterol, glucose and C reactive protein. The treatment of gingival diseases decreases the concentration of these risk factors in the blood of cardiovascular patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

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
    • RS
      • Porto Alegre, RS, Brazil, 90035003
        • Federal University of Rio Grande do Sul, School of Dentistry and University Hospital

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

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 35 years and older
  • coronary artery disease
  • more than 10 teeth
  • chronic periodontitis defined as 2 non-adjacent teeth with probing depth 5+mm and periodontal attachment loss 4+mm

Exclusion Criteria:

  • use of antibiotics in the last 6 months
  • periodontal therapy in the last 12 months

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive treatment
Test treatment group
Device: Subgingival scaling and root planing
Oral hygiene instruction and motivation will be provided altogether with scaling and root planing of all teeth affected by periodontitis under local anesthesia
Other: Community treatment
Control treatment group
Device: Oral prophylaxis
One session of supraginigval calculus removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in C reactive protein
Time Frame: Baseline, 3, 6 and 12 months
Baseline, 3, 6 and 12 months
Changes in flow-mediated dilation
Time Frame: Baseline, 1, 3 and 6 months
Baseline, 1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in Interleukin 1B concentrations
Time Frame: Baseline, 3, 6, 12 months
Baseline, 3, 6, 12 months
Changes in TNF alpha
Time Frame: Baseline, 3, 6, 12 months
Baseline, 3, 6, 12 months
Changes in Interleukin 8
Time Frame: Baseline, 3, 6, 12 months
Baseline, 3, 6, 12 months
Changes in Interleukin 6
Time Frame: Baseline, 3, 6, 12 months
Baseline, 3, 6, 12 months
Changes in Cholesterol
Time Frame: Baseline, 3, 6, 12 months
Baseline, 3, 6, 12 months
Changes in Glycated hemoglobin
Time Frame: Baseline, 3, 6, 12 months
Baseline, 3, 6, 12 months
Changes in LDL/HDL
Time Frame: Baseline, 3, 6, 12 months
Baseline, 3, 6, 12 months
Changes in Fibrinogen
Time Frame: Baseline, 3, 6, 12 months
Baseline, 3, 6, 12 months

Collaborators and Investigators

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

Sponsor

Federal University of Rio Grande do Sul

Investigators

  • Study Chair: Alex N Haas, PhD, Federal University of Rio Grande do Sul, Periodontology
  • Study Chair: Cassiano K Rosing, PhD, Federal University of Rio Grande do Sul, Periodontology
  • Study Chair: Carisi Polanczyk, PhD, Federal University of Rio Grande do Sul, Cardiology
  • Study Chair: Eneida RR Rabelo da Silva, PhD, Federal University of Rio Grande do Sul
  • Principal Investigator: Marco A Saffi, MS, Federal University of Rio Grande do Sul, Cardiology
  • Principal Investigator: Cassio Kampits, MS, Federal University of Rio Grande do Sul, Periodontology
  • Principal Investigator: Ingrid Sanada, MS, Federal University of Rio Grande do Sul, Periodontology
  • Principal Investigator: Marlon Montenegro, MS, Federal University of Rio Grande do Sul, Periodontology
  • Study Director: Mariana V Furtado, MS, Federal University of Rio Grande do Sul, Cardiology

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

Helpful Links

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, 2012

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimate)

June 1, 2012

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCPA110146

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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