Clinical trial NCT03072342: PERIODONTITIS AND VASCULAR DYSFUNCTION
Official title: INTENSIVE TREATMENT FOR PERIODONTAL DISEASE: A MODEL OF AND THERAPY OF INFLAMMATORY VASCULAR DYSFUNCTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Intimal Medial Thickness of Internal Carotid Artery
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Common Carotid Intima-media Thickness (cIMT)
timeFrame: cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment
Secondary outcomes:
measure: Brachial artery Flow-mediated dilatation (FMD)
timeFrame: FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment
measure: Pulse-wave velocity (PWV)
timeFrame: PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
measure: Brachial artery Flow-mediated dilatation (FMD)
timeFrame: FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment
measure: Blood inflammatory markers
timeFrame: Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
measure: Oxidative stress
timeFrame: Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCL-Eastman Dental Institute
Study officials:
affiliation: UCL
name: John Deanfield, MD
role: STUDY_CHAIR
References:
citation: Orlandi M, Masi S, Bhowruth D, Leira Y, Georgiopoulos G, Yellon D, Hingorani A, Chiesa ST, Hausenloy DJ, Deanfield J, D'Aiuto F. Remote Ischemic Preconditioning Protects Against Endothelial Dysfunction in a Human Model of Systemic Inflammation: A Randomized Clinical Trial. Arterioscler Thromb Vasc Biol. 2021 Aug;41(8):e417-e426. doi: 10.1161/ATVBAHA.121.316388. Epub 2021 Jun 10.