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Periodontal Therapy in Coronary Artery Patients (PerioCardio)

Primary Purpose

Cardiovascular Diseases, Atheroma, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Subgingival scaling and root planing
Oral prophylaxis
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Coronary artery disease, C reactive protein, Periodontitis, Periodontal therapy, Flow-mediated dilation

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Rio Grande do Sul, School of Dentistry and University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Comprehensive treatment

Community treatment

Arm Description

Test treatment group

Control treatment group

Outcomes

Primary Outcome Measures

Changes in C reactive protein
Changes in flow-mediated dilation

Secondary Outcome Measures

Changes in Interleukin 1B concentrations
Changes in TNF alpha
Changes in Interleukin 8
Changes in Interleukin 6
Changes in Cholesterol
Changes in Glycated hemoglobin
Changes in LDL/HDL
Changes in Fibrinogen

Full Information

First Posted
May 29, 2012
Last Updated
September 26, 2019
Sponsor
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT01609725
Brief Title
Periodontal Therapy in Coronary Artery Patients
Acronym
PerioCardio
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Atheroma, Coronary Artery Disease
Keywords
Coronary artery disease, C reactive protein, Periodontitis, Periodontal therapy, Flow-mediated dilation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive treatment
Arm Type
Experimental
Arm Description
Test treatment group
Arm Title
Community treatment
Arm Type
Other
Arm Description
Control treatment group
Intervention Type
Device
Intervention Name(s)
Subgingival scaling and root planing
Intervention Description
Oral hygiene instruction and motivation will be provided altogether with scaling and root planing of all teeth affected by periodontitis under local anesthesia
Intervention Type
Device
Intervention Name(s)
Oral prophylaxis
Intervention Description
One session of supraginigval calculus removal
Primary Outcome Measure Information:
Title
Changes in C reactive protein
Time Frame
Baseline, 3, 6 and 12 months
Title
Changes in flow-mediated dilation
Time Frame
Baseline, 1, 3 and 6 months
Secondary Outcome Measure Information:
Title
Changes in Interleukin 1B concentrations
Time Frame
Baseline, 3, 6, 12 months
Title
Changes in TNF alpha
Time Frame
Baseline, 3, 6, 12 months
Title
Changes in Interleukin 8
Time Frame
Baseline, 3, 6, 12 months
Title
Changes in Interleukin 6
Time Frame
Baseline, 3, 6, 12 months
Title
Changes in Cholesterol
Time Frame
Baseline, 3, 6, 12 months
Title
Changes in Glycated hemoglobin
Time Frame
Baseline, 3, 6, 12 months
Title
Changes in LDL/HDL
Time Frame
Baseline, 3, 6, 12 months
Title
Changes in Fibrinogen
Time Frame
Baseline, 3, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex N Haas, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul, Periodontology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cassiano K Rosing, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul, Periodontology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carisi Polanczyk, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul, Cardiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eneida RR Rabelo da Silva, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marco A Saffi, MS
Organizational Affiliation
Federal University of Rio Grande do Sul, Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cassio Kampits, MS
Organizational Affiliation
Federal University of Rio Grande do Sul, Periodontology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ingrid Sanada, MS
Organizational Affiliation
Federal University of Rio Grande do Sul, Periodontology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marlon Montenegro, MS
Organizational Affiliation
Federal University of Rio Grande do Sul, Periodontology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mariana V Furtado, MS
Organizational Affiliation
Federal University of Rio Grande do Sul, Cardiology
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Rio Grande do Sul, School of Dentistry and University Hospital
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035003
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21324167
Citation
Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46.
Results Reference
background
PubMed Identifier
18294231
Citation
Paraskevas S, Huizinga JD, Loos BG. A systematic review and meta-analyses on C-reactive protein in relation to periodontitis. J Clin Periodontol. 2008 Apr;35(4):277-90. doi: 10.1111/j.1600-051X.2007.01173.x. Epub 2008 Feb 20.
Results Reference
background
PubMed Identifier
19774803
Citation
Blaizot A, Vergnes JN, Nuwwareh S, Amar J, Sixou M. Periodontal diseases and cardiovascular events: meta-analysis of observational studies. Int Dent J. 2009 Aug;59(4):197-209.
Results Reference
background
PubMed Identifier
22514251
Citation
Lockhart PB, Bolger AF, Papapanou PN, Osinbowale O, Trevisan M, Levison ME, Taubert KA, Newburger JW, Gornik HL, Gewitz MH, Wilson WR, Smith SC Jr, Baddour LM; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Council on Clinical Cardiology. Periodontal disease and atherosclerotic vascular disease: does the evidence support an independent association?: a scientific statement from the American Heart Association. Circulation. 2012 May 22;125(20):2520-44. doi: 10.1161/CIR.0b013e31825719f3. Epub 2012 Apr 18.
Results Reference
background
PubMed Identifier
30761568
Citation
Montenegro MM, Ribeiro IWJ, Kampits C, Saffi MAL, Furtado MV, Polanczyk CA, Haas AN, Rosing CK. Randomized controlled trial of the effect of periodontal treatment on cardiovascular risk biomarkers in patients with stable coronary artery disease: Preliminary findings of 3 months. J Clin Periodontol. 2019 Mar;46(3):321-331. doi: 10.1111/jcpe.13085. Epub 2019 Mar 6.
Results Reference
derived
PubMed Identifier
24010954
Citation
Saffi MA, Furtado MV, Montenegro MM, Ribeiro IW, Kampits C, Rabelo-Silva ER, Polanczyk CA, Rosing CK, Haas AN. The effect of periodontal therapy on C-reactive protein, endothelial function, lipids and proinflammatory biomarkers in patients with stable coronary artery disease: study protocol for a randomized controlled trial. Trials. 2013 Sep 6;14:283. doi: 10.1186/1745-6215-14-283.
Results Reference
derived
Links:
URL
http://www.ufrgs.br/odonto
Description
School of Dentistry homepage
URL
http://www.hcpa.ufrgs.br
Description
University Hospital homepage

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Periodontal Therapy in Coronary Artery Patients

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