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

This study has been completed.
Sponsor:
Information provided by:
Sheikh Zayed Federal Postgraduate Medical Institute
ClinicalTrials.gov Identifier:
NCT01201746
First received: September 13, 2010
Last updated: September 15, 2010
Last verified: September 2010

September 13, 2010
September 15, 2010
July 2008
April 2009   (final data collection date for primary outcome measure)
high-sensitivity C-Reactive Protein (hsCRP)
Same as current
Complete list of historical versions of study NCT01201746 on ClinicalTrials.gov Archive Site
  • Fibrinogen
  • White Blood Cells
Same as current
Not Provided
Not Provided
 
Influence of Periodontal Treatment on Systemic Inflammatory Mediators
Influence of Periodontal Treatment on Systemic Inflammatory Mediators:hsC-reactive Protein, Fibrinogen and White Blood Cells in CHD Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Periodontal Disease
  • Coronary Heart Disease
  • Procedure: No treatment
    No treatment
    Other Name: Control group
  • Procedure: Periodontal therapy
    Scaling, root planning and oral hygiene instructions
    Other Name: Experimental group
  • Experimental: Periodontal Therapy
    Scaling Root planing and oral hygiene instructions
    Intervention: Procedure: Periodontal therapy
  • No Intervention: No treatment
    Intervention: Procedure: No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
317
May 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
31 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01201746
PU-D/314/Acad, HEC-20-685/06
Yes
Ayyaz Ali Khan / Associate Professor, Sheikh Zayed Federal Postgraduate Medical Institute
Sheikh Zayed Federal Postgraduate Medical Institute Faculty of Medicine & Dentistry
Not Provided
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
Sheikh Zayed Federal Postgraduate Medical Institute
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP