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Influence of Periodontal Treatment on Systemic Inflammatory Mediators (Perio-CHD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201746
First Posted: September 15, 2010
Last Update Posted: October 14, 2016
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.
Collaborator:
Pakistan Higher Education Commission
Information provided by (Responsible Party):
Syed Akhtar Hussain Bokhari, Sheikh Zayed Federal Postgraduate Medical Institute
  Purpose

Currently the research issue in establishing the role of periodontal disease (PD) in coronary heart disease (CHD) risk is to define the pathways that lead to cause-effect relationship between PD and CHD. There is no consensus on definition of a periodontal disease case or the threshold level that may give clear indication for this relationship. Periodontal therapy has been used in different studies with the hope that a change in periodontal disease status may modify the factors associated with CHD risk. Many of these studies, on role of periodontal therapy in the reduction of CHD associated risk-factors, were based on small study samples, and very few studies were randomized controlled trials. So a need for large prospective studies is warranted in literature.----------- A single-blind parallel-arm randomized controlled clinical trial was designed to observe the influence of periodontal treatment on serum inflammatory mediators of hsC-reactive protein, white blood cells and fibrinogen in CHD patients.

Hypothesis: Periodontal therapy in CHD patients, by reducing periodontal inflammation, may decrease the host systemic inflammatory burden associated with atherogenic processes.


Condition Intervention
Periodontal Disease Coronary Heart Disease Procedure: Delayed treatment Procedure: Periodontal therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Influence of Periodontal Treatment on Systemic Inflammatory Mediators:hsC-reactive Protein, Fibrinogen and White Blood Cells in CHD Patients

Further study details as provided by Syed Akhtar Hussain Bokhari, Sheikh Zayed Federal Postgraduate Medical Institute:

Primary Outcome Measures:
  • high-sensitivity C-Reactive Protein (hsCRP) [ Time Frame: 1-3 months ]

Secondary Outcome Measures:
  • Fibrinogen [ Time Frame: 1-3 months ]
  • White Blood Cells [ Time Frame: 1-3 months ]

Enrollment: 317
Study Start Date: July 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Periodontal Therapy
Scaling Root planing and oral hygiene instructions
Procedure: Periodontal therapy
Scaling, root planning and oral hygiene instructions
Other Name: Experimental group
Placebo Comparator: Delayed treatment
Scaling Root planing and oral hygiene instructions
Procedure: Delayed treatment
Scaling, Root Planing and oral hygiene instruction
Other Name: Control group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A. General/Medical

  1. Any race/ethnic group
  2. Aged > 30 years
  3. Male or female
  4. CHD case (CHD angiographically confirmed)
  5. CHD diagnosed > 3 months prior to entry into study.
  6. No acute or chronic systemic conditions (see exclusion criteria below)
  7. No medications/medication history that can interfere with the study (see exclusion criteria below)
  8. Non-smoker (=Never smoker) or former smoker (=Does not smoke now and has not smoked at all for a minimum of the last 12 consecutive months)
  9. Able and willing to comply with study procedures
  10. Able and willing to be available for the duration of the study
  11. Able and willing to provide signed informed consent

B. Oral/Periodontal

  1. Dentate with at least 14 natural teeth, excluding third molars, that can be evaluated periodontally.
  2. Baseline whole mouth BOP > 20% of sites.
  3. Periodontitis case; periodontitis case defined as subject having ≥ 4 teeth with ≥ 1 site with PPD ≥ 4 mm & CAL ≥ 3 mm at same site
  4. No mechanical periodontal therapy in the last 6 months.
  5. No acute oral diseases (mucosal lesions), oral infections, need for immediate dental/periodontal care (e.g., NUG).

Exclusion Criteria:

A. General/Medical

  1. Age ≤ 30 years
  2. Not fulfilling criteria of defined CHD case
  3. Fulfilling criteria of defined CHD case, but diagnosed ≤ 3 months prior to start of study
  4. Current smoker
  5. Former smoker who does not smoke but who has smoked ≥ 1 cigarette (or equivalent, in form of water pipe, pipe, cigar) in the last 12 months.
  6. Females pregnant or lactating
  7. Systemic chronic conditions known to be associated with periodontitis or with changes in systemic inflammation: Diabetes,Rheumatoid Arthritis, Rheumatic Fever, SLE, Malignancy, Respiratory diseases, Renal diseases, Other (e.g., autoimmune diseases, fungal infections, immunological deficiencies, etc.)
  8. Systemic acute conditions known to affect systemic markers of inflammation: Acute bacterial infection, Acute viral infection (common cold, influenza, sinusitis), Orthopedic trauma, Surgery
  9. Medications known to affect systemic inflammatory biomarkers: Statins, Systemic steroids, Non-steroidal anti-inflammatory drugs, Immunosuppressants,
  10. Medications potentially affecting systemic inflammatory markers, if therapy started less than 3 months prior to study such as Hormone replacement therapy, Contraceptives
  11. Systemic antibiotic therapy in the last 3 months
  12. Unable or unwilling to comply with study procedures
  13. Unable or unwilling to be available for the duration of the study
  14. Unable or unwilling to provide signed informed consent

B. Oral/Periodontal

  1. <14 teeth that can be periodontally evaluated (excluding 3rd molars)
  2. BOP ≤ 20% of sites
  3. Not fulfilling criteria of defined periodontitis case
  4. Having received any periodontal therapy within last 6 months
  5. Topical/local antibiotic or anti-inflammatory therapy in last 6 months
  6. Acute oral infections
  7. Oral wounds, including recent (< 2 months) extractions
  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): NCT01201746


Locations
Pakistan
Punjab Institute of Cardiology
Lahore, Punjab, Pakistan, 54300
Sponsors and Collaborators
Sheikh Zayed Federal Postgraduate Medical Institute
Pakistan Higher Education Commission
Investigators
Study Director: Ayyaz A Khan, Ph.D. Sheikh Zayed Federal Postgraduate Medical Institute
Principal Investigator: Syed Akhtar H Bokhari, MCPS Sheikh Zayed Federal Postgraduate Medical Institute
Study Chair: Mohammad Azhar, MRCP Punjab Institute of Cardiology
  More Information

Responsible Party: Syed Akhtar Hussain Bokhari, PhD Candidate, Sheikh Zayed Federal Postgraduate Medical Institute
ClinicalTrials.gov Identifier: NCT01201746     History of Changes
Other Study ID Numbers: PU-D/314/Acad
HEC-20-685/06 ( Other Grant/Funding Number: Higher Education Commission, Govt of Pakistan, Islamabad )
First Submitted: September 13, 2010
First Posted: September 15, 2010
Last Update Posted: October 14, 2016
Last Verified: September 2010

Keywords provided by Syed Akhtar Hussain Bokhari, Sheikh Zayed Federal Postgraduate Medical Institute:
Non-surgical periodontal therapy
Coronary heart disease (CHD)
periodontal Disease
hsCRP
Fibrinogen
WBCs

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Periodontal Diseases
Gingival Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Mouth Diseases
Stomatognathic Diseases


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