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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Periodontal Disease
• Intervention / Treatment: Procedure: Periodontal therapy; Procedure: Delayed treatment

• Study Type: Interventional
• Enrollment (Actual): 317
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54300
      • Punjab Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Periodontal Therapy; Scaling Root planing and oral hygiene instructions	Procedure: Periodontal therapy; Scaling, root planning and oral hygiene instructions; Other Names: Experimental group
Placebo Comparator: Delayed treatment; Scaling Root planing and oral hygiene instructions	Procedure: Delayed treatment; Scaling, Root Planing and oral hygiene instruction; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
high-sensitivity C-Reactive Protein (hsCRP)	1-3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Fibrinogen	1-3 months
White Blood Cells	1-3 months

Collaborators and Investigators

• Sponsor: Sheikh Zayed Federal Postgraduate Medical Institute
• Collaborators: Higher Education Commission (Pakistan)
• 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

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 13, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (Estimate): September 15, 2010

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Fibrinogen; hsCRP; Non-surgical periodontal therapy; Coronary heart disease (CHD); periodontal Disease; WBCs
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stomatognathic Diseases; Mouth Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Periodontal Diseases
• Other Study ID Numbers: PU-D/314/Acad; HEC-20-685/06 (Other Grant/Funding Number: Higher Education Commission, Govt of Pakistan, Islamabad)