Periodontal Therapy in Coronary Artery Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Diseases Atheroma Coronary Artery Disease	Device: Subgingival scaling and root planing Device: Oral prophylaxis	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:

Changes in C reactive protein [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
Changes in flow-mediated dilation [ Time Frame: Baseline, 1, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in Interleukin 1B concentrations [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
Changes in TNF alpha [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
Changes in Interleukin 8 [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
Changes in Interleukin 6 [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
Changes in Cholesterol [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
Changes in Glycated hemoglobin [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
Changes in LDL/HDL [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
Changes in Fibrinogen [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2012
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
Community treatment Control treatment group	Device: Oral prophylaxis One session of supraginigval calculus removal

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609725

Contacts

Contact: Alex N Haas, PhD	+55 51 33085318	alexnhaas@gmail.com
Contact: Cassiano K Rosin, PhD	+55 51 33085318	periodontia@ufrgs.br

Locations

Brazil
Federal University of Rio Grande do Sul, School of Dentistry and University Hospital	Recruiting
Porto Alegre, RS, Brazil, 90035003
Contact: Alex Haas, PhD +55 51 33085318 periodontia@ufrgs.br
Principal Investigator: Cassio Kampits, MS
Principal Investigator: Ingrid Sanada, MS
Principal Investigator: Marlon Montenegro, MS

Sponsors and Collaborators

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

More Information

Additional Information:

School of Dentistry homepage This link exits the ClinicalTrials.gov site

University Hospital homepage This link exits the ClinicalTrials.gov site

Publications:

Ramírez 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.

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. Epub 2008 Feb 20. Review.

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. Review.

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; on behalf of the 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. 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):2520-2544. Epub 2012 Apr 18.

Responsible Party:	Alex Nogueira Haas, Professor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:	NCT01609725 History of Changes
Other Study ID Numbers:	HCPA110146
Study First Received:	May 29, 2012
Last Updated:	June 4, 2012
Health Authority:	Brazil: Ministry of Health, Health National Conseil, Plataforma Brasil

Keywords provided by Federal University of Rio Grande do Sul:

Coronary artery disease
C reactive protein
Periodontitis
Periodontal therapy
Flow-mediated dilation

Additional relevant MeSH terms:

Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Plaque, Atherosclerotic

Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013

Periodontal Therapy in Coronary Artery Patients (PerioCardio)