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CompletedNCT03072342Updated Jan 25, 2021

PERIODONTITIS AND VASCULAR DYSFUNCTION

An interventional study of Intensive Periodontal Treatment and Control Periodontal Treatment in Periodontitis and Intimal Medial Thickness of Internal Carotid Artery, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-25.

Sponsored by University College, London · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Apr 2013, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Periodontitis
  • Intimal Medial Thickness of Internal Carotid Artery

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In context

Periodontitis

1,664 studies on the registry are indexed under Periodontitis; 328 are open to participants now.

This study's enrollment of 190 is above the median of 45 across 1,206 interventional studies indexed under Periodontitis.

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Lead sponsor

University College, London is the lead sponsor of 647 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
190 participants (actual)

Study arms

  • Active comparator
    Intensive Periodontal Treatment (IPT)

    Procedure: Intensive Periodontal Treatment

  • Placebo comparator
    Control Periodontal Treatment (CPT)

    Procedure: Control Periodontal Treatment

Interventions

  • ProcedureIntensive Periodontal Treatment
  • ProcedureControl Periodontal Treatment
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What researchers measure

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.

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

Secondary outcomes

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

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Study locations

1 site
  • UCL-Eastman Dental Institute
    London, WC1X 8LD, United Kingdom
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References and documents

Publications

  • 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. PubMed 34107730 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03072342
Responsible party
Sponsor
First posted
Mar 7, 2017
Start date
Apr 16, 2013
Primary completion
Mar 30, 2020
Completion
Mar 30, 2020
Last update
Jan 25, 2021

Study contacts

John Deanfield, MD
study chair · UCL

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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