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

University College, London1 site in 1 country190 target enrollmentApril 16, 2013

ConditionsPeriodontitis Intimal Medial Thickness of Internal Carotid Artery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Periodontitis
Sponsor: University College, London
Enrollment: 190
Locations: 1
Primary Endpoint: Common Carotid Intima-media Thickness (cIMT)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 16, 2013

End Date

March 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University College, London

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Common Carotid Intima-media Thickness (cIMT)

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

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.

Secondary Outcomes

Brachial artery Flow-mediated dilatation (FMD)(FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment)
Pulse-wave velocity (PWV)(PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment)
Blood inflammatory markers(Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment)
Oxidative stress(Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment)