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PERIODONTITIS AND VASCULAR DYSFUNCTION

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ClinicalTrials.gov Identifier: NCT03072342
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment Phase
Periodontitis Intimal Medial Thickness of Internal Carotid Artery Procedure: Intensive Periodontal Treatment Procedure: Control Periodontal Treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INTENSIVE TREATMENT FOR PERIODONTAL DISEASE: A MODEL OF AND THERAPY OF INFLAMMATORY VASCULAR DYSFUNCTION
Actual Study Start Date : April 16, 2013
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072342


Contacts
Contact: Francesco D'Aiuto, DDS 02034561108 f.daiuto@ucl.ac.uk
Contact: Marco Orlandi, DDS 02034561276 m.orlandi@ucl.ac.uk

Locations
United Kingdom
UCL-Eastman Dental Institute Recruiting
London, United Kingdom, WC1X 8LD
Contact: Francesco D'Aiuto, DDS    02034561108    f.daiuto@ucl.ac.uk   
Principal Investigator: Francesco D'Aiuto, DDS         
Principal Investigator: Marco Orlandi, DDS         
Sponsors and Collaborators
University College, London
Investigators
Study Chair: John Deanfield, MD UCL

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03072342     History of Changes
Other Study ID Numbers: 13/0044
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Periodontitis
Atherosclerosis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases