Influence of Periodontal Treatment on Systemic Inflammatory Mediators

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Periodontal Treatment on Systemic Inflammatory Mediators:hsC-reactive Protein, Fibrinogen and White Blood Cells in CHD Patients

Conditions
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Periodontal Disease, Coronary Heart Disease

Intervention / Treatment
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* Procedure: Delayed treatment
* Procedure: Periodontal therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 31 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-surgical periodontal therapy, Coronary heart disease (CHD), periodontal Disease, hsCRP, Fibrinogen, WBCs