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PERIODONTITIS AND VASCULAR DYSFUNCTION

Primary Purpose

Periodontitis, Intimal Medial Thickness of Internal Carotid Artery

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intensive Periodontal Treatment
Control Periodontal Treatment
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • UCL-Eastman Dental Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intensive Periodontal Treatment (IPT)

Control Periodontal Treatment (CPT)

Arm Description

Outcomes

Primary Outcome Measures

Common Carotid Intima-media Thickness (cIMT)
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 Outcome Measures

Brachial artery Flow-mediated dilatation (FMD)
Assess whether pre-treatment (24hrs before) with remote ischaemic pre-conditioning will prevent acute inflammatory endothelial dysfunction induced by intensive periodontal treatment
Pulse-wave velocity (PWV)
Assess whether intensive periodontal therapy will cause amelioration of PWV at 12, 18 and 24 months follow up compared to standard periodontal therapy.
Brachial artery Flow-mediated dilatation (FMD)
Assess whether intensive periodontal therapy will cause amelioration of FMD at 12, 18 and 24 months follow up compared to standard periodontal therapy.
Blood inflammatory markers
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.
Oxidative stress
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.

Full Information

First Posted
March 1, 2017
Last Updated
January 22, 2021
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT03072342
Brief Title
PERIODONTITIS AND VASCULAR DYSFUNCTION
Official Title
INTENSIVE TREATMENT FOR PERIODONTAL DISEASE: A MODEL OF AND THERAPY OF INFLAMMATORY VASCULAR DYSFUNCTION
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 16, 2013 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Intimal Medial Thickness of Internal Carotid Artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Periodontal Treatment (IPT)
Arm Type
Active Comparator
Arm Title
Control Periodontal Treatment (CPT)
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Intensive Periodontal Treatment
Intervention Type
Procedure
Intervention Name(s)
Control Periodontal Treatment
Primary Outcome Measure Information:
Title
Common Carotid Intima-media Thickness (cIMT)
Description
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.
Time Frame
cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment
Secondary Outcome Measure Information:
Title
Brachial artery Flow-mediated dilatation (FMD)
Description
Assess whether pre-treatment (24hrs before) with remote ischaemic pre-conditioning will prevent acute inflammatory endothelial dysfunction induced by intensive periodontal treatment
Time Frame
FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment
Title
Pulse-wave velocity (PWV)
Description
Assess whether intensive periodontal therapy will cause amelioration of PWV at 12, 18 and 24 months follow up compared to standard periodontal therapy.
Time Frame
PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
Title
Brachial artery Flow-mediated dilatation (FMD)
Description
Assess whether intensive periodontal therapy will cause amelioration of FMD at 12, 18 and 24 months follow up compared to standard periodontal therapy.
Time Frame
FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment
Title
Blood inflammatory markers
Description
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.
Time Frame
Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
Title
Oxidative stress
Description
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.
Time Frame
Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Deanfield, MD
Organizational Affiliation
UCL
Official's Role
Study Chair
Facility Information:
Facility Name
UCL-Eastman Dental Institute
City
London
ZIP/Postal Code
WC1X 8LD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34107730
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.
Results Reference
derived

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PERIODONTITIS AND VASCULAR DYSFUNCTION

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