PERIODONTITIS AND VASCULAR DYSFUNCTION

Study Overview
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Brief Summary
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The investigators wish to assess whether intensive periodontal therapy will reduce the burden of chronic periodontal disease and will cause regression or prevent progression of atherosclerosis assessed by a surrogate end-point (carotid intima-media thickness) at 24 months compared to control periodontal therapy.

Official Title
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INTENSIVE TREATMENT FOR PERIODONTAL DISEASE: A MODEL OF AND THERAPY OF INFLAMMATORY VASCULAR DYSFUNCTION

Conditions
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Periodontitis, Intimal Medial Thickness of Internal Carotid Artery

Intervention / Treatment
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* Procedure: Intensive Periodontal Treatment
* Procedure: Control Periodontal Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be ≥ 18 years-old. Participants must have moderate to severe periodontitis (at least 30 periodontal pockets > 4mm with Bleeding on Probing) and radiographic signs of bone loss. Participants must have voluntarily signed the informed consent. Exclusion Criteria: Female participant is pregnant or lactating or of childbearing and not using acceptable methods of birth control. Participant is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit. Participant knowingly has HIV or Hepatitis. Participant has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided. Participant on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures. Participant had a course of periodontal therapy in the preceding 6 month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Intensive Periodontal Treatment (IPT)<br> | Procedure: Intensive Periodontal Treatment<br> <br> |
| Placebo Comparator: Control Periodontal Treatment (CPT)<br> | Procedure: Control Periodontal Treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Common Carotid Intima-media Thickness (cIMT) | Assess whether intensive periodontal therapy will cause regression or prevent progression of atherosclerosis assessed by carotid intima-media thickness at 24 months compared to standard periodontal therapy. | cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery Flow-mediated dilatation (FMD) | Assess whether pre-treatment (24hrs before) with remote ischaemic pre-conditioning will prevent acute inflammatory endothelial dysfunction induced by intensive periodontal treatment | FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment | 
| Pulse-wave velocity (PWV) | Assess whether intensive periodontal therapy will cause amelioration of PWV at 12, 18 and 24 months follow up compared to standard periodontal therapy. | PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment | 
| Brachial artery Flow-mediated dilatation (FMD) | Assess whether intensive periodontal therapy will cause amelioration of FMD at 12, 18 and 24 months follow up compared to standard periodontal therapy. | FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment | 
| Blood inflammatory markers | Assess whether intensive periodontal therapy will cause changes in the blood inflammatory markers profile at 2, 6, 12, 18 and 24 months follow up compared to standard periodontal therapy. | Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment | 
| Oxidative stress | Assess whether intensive periodontal therapy will cause changes in the oxidative stress profile at 2, 6, 12, 18 and 24 months follow up compared to standard periodontal therapy. | Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment |