PERIODONTITIS AND VASCULAR DYSFUNCTION

University College, London190 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

190

Conditions

Periodontitis Intimal Medial Thickness of Internal Carotid Artery

Interventions

Intensive Periodontal TreatmentPROCEDURE

Control Periodontal TreatmentPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants must be ≥ 18 years-old. 2. Participants must have moderate to severe periodontitis (at least 30 periodontal pockets \> 4mm with Bleeding on Probing) and radiographic signs of bone loss. 3. Participants must have voluntarily signed the informed consent. Exclusion Criteria: 1. Female participant is pregnant or lactating or of childbearing and not using acceptable methods of birth control. 2. 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. 3. Participant knowingly has HIV or Hepatitis. 4. Participant has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided. 5. Participant on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures. 6. Participant had a course of periodontal therapy in the preceding 6 month

Locations (1)

UCL-Eastman Dental Institute

London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment

Oxidative stress

Data from ClinicalTrials.gov

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