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Periodontal Therapy in Coronary Artery Patients (PerioCardio)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Alex Nogueira Haas, Federal University of Rio Grande do Sul.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609725
First Posted: June 1, 2012
Last Update Posted: June 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alex Nogueira Haas, Federal University of Rio Grande do Sul
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by Alex Nogueira Haas, Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Changes in C reactive protein [ Time Frame: Baseline, 3, 6 and 12 months ]
  • Changes in flow-mediated dilation [ Time Frame: Baseline, 1, 3 and 6 months ]

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

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: May 29, 2012
First Posted: June 1, 2012
Last Update Posted: June 9, 2015
Last Verified: June 2015

Keywords provided by Alex Nogueira Haas, 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