Condition category
Digestive System
Date applied
25/02/2014
Date assigned
25/02/2014
Last edited
18/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Moderate to severe periodontitis (PD) has been associated with a 20% increased risk of heart disease. Gum Disease may directly affect arteries wall structure, impair their dilatation capacity (ability to increase blood flow) and predispose to atherosclerosis (build up of fat). The nature of this association, however, has not yet been established. Treatment of periodontitis may also cause a transient state of systemic inflammation (swelling) with increase of concentrations of specific blood proteins (called acute phase proteins). This inflammatory state represents the body response to the local therapy and could affect blood vessels in the body. This study aims to understand better the possible impact if any, of periodontal disease (gum disease) on cardiovascular risk and general health.

Who can participate?
Adults over the age of 18 who have moderate to severe PD.

What does the study involve?
Participants either receive an intensive periodontal therapy or a control (fake therapy). Participants are asked to attend 15 visits to the study centre over 24 months. Participants are assessed for changes in acute phase proteins using non-invasive high resolution ultrasound scans of the arm and change in the thickness of the carotid arteries assessed by ultrasounds. Participants also may have a cycle of ischemia of their arm and its consequences on blood vessels.

What are the possible benefits and risks of participating?
Participants may benefit from improvement in their periodontal condition. There are no notable risks with participating.

Where is the study run from?
UCL Eastman Dental Institute And Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2013 to December 2019

Who is funding the study?
University College London (UK)

Who is the main contact?
Dr Francesco D'Aiuto

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francesco D'Aiuto

ORCID ID

Contact details

University College London
Gower Street
London
WC1E 6BT
United Kingdom
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f.daiuto@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14996

Study information

Scientific title

Intensive treatment for periodontal disease: A model of and therapy for inflammatory vascular dysfunction

Acronym

Study hypothesis

The possible aetiological role of infections on the development and progression of cardiovascular diseases has attracted greater attention over the last twenty years. Individuals with periodontitis present with a modest but statistically significant increased risk of vascular events compared to controls.

Ethics approval

London Queen Square Research Ethics Committee, 19/11/2012, ref: 06/Q0512/107

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Oral & Dental

Intervention

Current interventions as of 18/04/2017: Participants are randomly allocated to one of two groups. Participatns are asked to atten 15 visits, including a screening visit, baseline visits, and visits for their treatment.

Intensive periodontal treatment (IPT) group receive an intensive treatment consisting of mechanical debridement of the diseased dentition in a single session (4-6 hrs).

Control periodontal therapy (CPT): Participants receive an control therapy consisting of oral hygiene instructions, supragingival mechanical instrumentation and polishing.

Participants may also be randomised into have remote ischemic preconditioning or a matched placebo.

Previous interventions:
IPT and CPT, Individuals included into the intervention study will be randomized to two different periodontal therapy regimens: CPT or IPT. Patients in the IPT group will receive an intensive treatment consisting of mechanical debridement of the diseased dentition in a single session (4-6 hrs). Local anaesthesia will be used as necessary.
Control group patients (CPT) will receive oral hygiene instructions, supragingival mechanical instrumentation and polishing.

Intervention type

Other

Phase

Phase II/III

Drug names

Primary outcome measures

Current primary outcome measure as of 18/04/2017:
Common carotid intima media thickness (c-IMT) is measured using an ultrasound at baseline, 12 and 24 months.

Previous primary outcome measures:
C-IMT; Timepoint(s): 12 Months, 24 Months

Secondary outcome measures

Current secondary outcome measures:
1. Brachial artery flow-mediated dilatation (FMD) is measured using a blood pressure cuff at baseline, 24 hours and 1 week after periodontal treatment.
2. Pulse-wave velocity is assessed at baseline, two, six, 12, 18 and 24 months after peridontal treatment
3. Blood inflammatory markers are measured using blood tests at baseline, two, six, 12, 18 and 24 months after peridontal treatment
4. Oxidative stressis assessed at baseline, two, six, 12, 18 and 24 months after peridontal treatment
5. Masticatory function is assessed at two time-points.

Previous secondary outcome meaures:
1. Biomarkers; Timepoint(s): Every 6 months for 24 months
2. Clinical Periodontal Measures; Timepoint(s): Every 12 months
3. FMD; Timepoint(s): Every 6 months up to 24 months
4. PVW; Timepoint(s): Every 6 months up to 24 months

Overall trial start date

01/04/2013

Overall trial end date

01/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subject must be > 18 years
2. Subject must have moderate to severe PD (at least 30 periodontal pockets >4mm with Bleeding on Probing)
3. Subject must have voluntarily signed the informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 284; UK Sample Size: 284

Participant exclusion criteria

1. Female subject is pregnant or lactating or of childbearing and not using acceptable methods of birth control
2. Subject 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. Subject knowingly has HIV or Hepatitis
4. Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided
5. Subjects on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures
6. Subjects had a course of periodontal therapy in the preceding 6 month

Recruitment start date

01/04/2013

Recruitment end date

01/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Eastman Dental Institute
256 Gray’s Inn Road
London
WC1X 8LD
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Academic Unit Respiratory Medicine
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Johnson & Johnson Consumer Services (EAME) Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NIHR University College London Hospitals Biomedical Research Centre; Grant Codes: F189

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/04/2017: Internal review. Updated ethics information. Overall trial end date was updated from 31/12/2014 to 01/12/2019. Recruitment end dates were changed from 31/12/2014 to 01/12/2017. Added plain English summary. Updated Trial Participating centre from University College London (UK) to Eastman Dental Institute. Updated interventions and outcome measures. 21/02/2017: No publications found in PubMed, verifying study status with principal investigator.