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PERIODONTITIS AND VASCULAR DYSFUNCTION

University College London (UCL) logo

University College London (UCL)

Status

Completed

Conditions

Intimal Medial Thickness of Internal Carotid Artery
Periodontitis

Treatments

Procedure: Intensive Periodontal Treatment
Procedure: Control Periodontal Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03072342
13/0044

Details and patient eligibility

About

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.

Enrollment

190 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

190 participants in 2 patient groups, including a placebo group

Intensive Periodontal Treatment (IPT)
Active Comparator group
Treatment:
Procedure: Intensive Periodontal Treatment
Control Periodontal Treatment (CPT)
Placebo Comparator group
Treatment:
Procedure: Control Periodontal Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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