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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College, London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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