PERIODONTITIS AND VASCULAR DYSFUNCTION

January 22, 2021 updated by: University College, London

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1X 8LD
        • UCL-Eastman Dental Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intensive Periodontal Treatment (IPT)
Procedure: Intensive Periodontal Treatment
Placebo Comparator: Control Periodontal Treatment (CPT)
Procedure: Control Periodontal Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment
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.
PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
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.
FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment
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.
Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
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.
Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Study Chair: John Deanfield, MD, UCL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2013

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/0044

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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