NCT03072342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2013

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

January 25, 2021

Status Verified

February 1, 2020

Enrollment Period

7 years

First QC Date

March 1, 2017

Last Update Submit

January 22, 2021

Conditions

PeriodontitisIntimal Medial Thickness of Internal Carotid Artery

Outcome Measures

Primary Outcomes (1)

  • 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.

    cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment

Secondary Outcomes (5)

  • Brachial artery Flow-mediated dilatation (FMD)

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

  • Pulse-wave velocity (PWV)

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

  • Brachial artery Flow-mediated dilatation (FMD)

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

  • Blood inflammatory markers

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

  • Oxidative stress

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

Study Arms (2)

Intensive Periodontal Treatment (IPT)

ACTIVE COMPARATOR
Procedure: Intensive Periodontal Treatment

Control Periodontal Treatment (CPT)

PLACEBO COMPARATOR
Procedure: Control Periodontal Treatment

Interventions

Intensive Periodontal TreatmentPROCEDURE
Intensive Periodontal Treatment (IPT)
Control Periodontal TreatmentPROCEDURE
Control Periodontal Treatment (CPT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL-Eastman Dental Institute

London, WC1X 8LD, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34107730DERIVED

MeSH Terms

Conditions

PeriodontitisCarotid Intimal Medial Thickness 1

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • John Deanfield, MD

    UCL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 7, 2017

Study Start

April 16, 2013

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

January 25, 2021

Record last verified: 2020-02

Locations

GB(1)