Condition category
Digestive System
Date applied
25/02/2014
Date assigned
25/02/2014
Last edited
25/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

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
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.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14996

Ethics approval

06/Q0512/107; First MREC approval date 19/11/2012

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

Condition

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

Intervention

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

C-IMT; Timepoint(s): 12 Months, 24 Months

Secondary outcome measures

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

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Each subject must meet all of the following inclusion criteria to be enrolled in the study:
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

Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
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

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London, Gower Street
London
WC1E 6BT
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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes