Influence of Periodontal Treatment on Systemic Inflammatory Mediators (Perio-CHD)
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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: No treatment Procedure: Periodontal therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- high-sensitivity C-Reactive Protein (hsCRP)
- Fibrinogen
- White Blood Cells
| 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
|
| No Intervention: No treatment |
Procedure: No treatment
No treatment
Other Name: Control group
|
Eligibility| Ages Eligible for Study: | 31 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A. General/Medical
- Any race/ethnic group
- Aged > 30 years
- Male or female
- CHD case (CHD angiographically confirmed)
- CHD diagnosed > 3 months prior to entry into study.
- No acute or chronic systemic conditions (see exclusion criteria below)
- No medications/medication history that can interfere with the study (see exclusion criteria below)
- 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)
- Able and willing to comply with study procedures
- Able and willing to be available for the duration of the study
- Able and willing to provide signed informed consent
B. Oral/Periodontal
- Dentate with at least 14 natural teeth, excluding third molars, that can be evaluated periodontally.
- Baseline whole mouth BOP > 20% of sites.
- Periodontitis case; periodontitis case defined as subject having ≥ 4 teeth with ≥ 1 site with PPD ≥ 4 mm & CAL ≥ 3 mm at same site
- No mechanical periodontal therapy in the last 6 months.
- No acute oral diseases (mucosal lesions), oral infections, need for immediate dental/periodontal care (e.g., NUG).
Exclusion Criteria:
A. General/Medical
- Age ≤ 30 years
- Not fulfilling criteria of defined CHD case
- Fulfilling criteria of defined CHD case, but diagnosed ≤ 3 months prior to start of study
- Current smoker
- 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.
- Females pregnant or lactating
- 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.)
- Systemic acute conditions known to affect systemic markers of inflammation: Acute bacterial infection, Acute viral infection (common cold, influenza, sinusitis), Orthopedic trauma, Surgery
- Medications known to affect systemic inflammatory biomarkers: Statins, Systemic steroids, Non-steroidal anti-inflammatory drugs, Immunosuppressants,
- Medications potentially affecting systemic inflammatory markers, if therapy started less than 3 months prior to study such as Hormone replacement therapy, Contraceptives
- Systemic antibiotic therapy in the last 3 months
- Unable or unwilling to comply with study procedures
- Unable or unwilling to be available for the duration of the study
- Unable or unwilling to provide signed informed consent
B. Oral/Periodontal
- <14 teeth that can be periodontally evaluated (excluding 3rd molars)
- BOP ≤ 20% of sites
- Not fulfilling criteria of defined periodontitis case
- Having received any periodontal therapy within last 6 months
- Topical/local antibiotic or anti-inflammatory therapy in last 6 months
- Acute oral infections
- Oral wounds, including recent (< 2 months) extractions
Contacts and Locations| Pakistan | |
| Punjab Institute of Cardiology | |
| Lahore, Punjab, Pakistan, 54300 | |
| 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
No publications provided
| Responsible Party: | Ayyaz Ali Khan / Associate Professor, 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 |
| Study First Received: | September 13, 2010 |
| Last Updated: | September 15, 2010 |
| Health Authority: | Pakistan: Research Ethics Committee, Punjab Institute of Cardiology Lahore |
Keywords provided by Sheikh Zayed Federal Postgraduate Medical Institute:
|
Non-surgical periodontal therapy Coronary heart disease (CHD) periodontal Disease |
hsCRP Fibrinogen WBCs |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Periodontal Diseases Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013