Periodontal Therapy in Coronary Artery Patients

Study Overview
=================
Brief Summary
-----------------
Gingival inflammation has been associated with cardiovascular diseases, including heart attack and stroke, because of elevation of blood risk markers such as cholesterol, glucose and C reactive protein. The treatment of gingival diseases decreases the concentration of these risk factors in the blood of cardiovascular patients.

Official Title
-----------------
Impact of Periodontal Therapy in Flow-mediated Dilation and Serum Levels of Cardiovascular Risk Biomarkers in Coronary Artery Disease Patients: 12 Months Randomized Controlled Trial

Conditions
-----------------
Cardiovascular Diseases, Atheroma, Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Subgingival scaling and root planing
* Device: Oral prophylaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 35 years and older coronary artery disease more than 10 teeth chronic periodontitis defined as 2 non-adjacent teeth with probing depth 5+mm and periodontal attachment loss 4+mm Exclusion Criteria: use of antibiotics in the last 6 months periodontal therapy in the last 12 months

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive treatment<br>Test treatment group | Device: Subgingival scaling and root planing<br>* Oral hygiene instruction and motivation will be provided altogether with scaling and root planing of all teeth affected by periodontitis under local anesthesia<br>|
| Other: Community treatment<br>Control treatment group | Device: Oral prophylaxis<br>* One session of supraginigval calculus removal<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in C reactive protein |  | Baseline, 3, 6 and 12 months | 
| Changes in flow-mediated dilation |  | Baseline, 1, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Interleukin 1B concentrations |  | Baseline, 3, 6, 12 months | 
| Changes in TNF alpha |  | Baseline, 3, 6, 12 months | 
| Changes in Interleukin 8 |  | Baseline, 3, 6, 12 months | 
| Changes in Interleukin 6 |  | Baseline, 3, 6, 12 months | 
| Changes in Cholesterol |  | Baseline, 3, 6, 12 months | 
| Changes in Glycated hemoglobin |  | Baseline, 3, 6, 12 months | 
| Changes in LDL/HDL |  | Baseline, 3, 6, 12 months | 
| Changes in Fibrinogen |  | Baseline, 3, 6, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease, C reactive protein, Periodontitis, Periodontal therapy, Flow-mediated dilation