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Completed

NCT Number: NCT03072342

PERIODONTITIS AND VASCULAR DYSFUNCTION

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.

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Key information

Conditions

Periodontitis Carotid Intimal Medial Thickness 1 Intimal Medial Thickness of Internal Carotid Artery Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCL-Eastman Dental Institute

London, WC1X 8LD, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive Periodontal Treatment

Procedure

Control Periodontal Treatment

Procedure

Primary outcomes

  1. 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

  1. Brachial artery Flow-mediated dilatation (FMD)

    Time frame: FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment

    Assess whether pre-treatment (24hrs before) with remote ischaemic pre-conditioning will prevent acute inflammatory endothelial dysfunction induced by intensive periodontal treatment

  2. Pulse-wave velocity (PWV)

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

    Assess whether intensive periodontal therapy will cause amelioration of PWV at 12, 18 and 24 months follow up compared to standard periodontal therapy.

  3. Brachial artery Flow-mediated dilatation (FMD)

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

    Assess whether intensive periodontal therapy will cause amelioration of FMD at 12, 18 and 24 months follow up compared to standard periodontal therapy.

  4. Blood inflammatory markers

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

    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.

  5. Oxidative stress

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

    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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2017
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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