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Periodontal Therapy in Coronary Artery Patients (PerioCardio)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Federal University of Rio Grande do Sul.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Alex Nogueira Haas, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01609725
First received: May 29, 2012
Last updated: June 4, 2012
Last verified: June 2012
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Additional 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
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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014