Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
27/08/2014
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 Jean Suvan

ORCID ID

Contact details

Eastman Dental Institute
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
j.suvan@eastman.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5280

Study information

Scientific title

Treatment of periodontitis and metabolic control in patients with type 2 diabetes mellitus: a single-centre randomised interventional trial

Acronym

DRN211

Study hypothesis

This study aims at assessing the potential benefit of successful periodontitis treatment on glucose control in people with type 2 diabetes. The secondary aims include changes in vascular function, wound healing and inflammation and quality of life. The study will involve 280 subjects that suffer both from type 2 diabetes and moderate to advanced periodontitis. Study follow-up is at 12 months. Participants will be randomly assigned to either a control or to an intensive periodontal treatment (test group). Blood samples will be collected at almost every visit to assess glucose control between study groups. We will also collect samples to assess the changes in wound healing and blood vessel health before and after gum therapy in both groups. A subgroup of 30 participants will also undergo more detailed analysis of gingival wound healing processes after periodontal therapy.

Ethics approval

The Joint UCL/UCLH Committees on the Ethics of Human Research, 27/11/2007, ref: 07/H0714/97

Study design

Single-centre randomised interventional prevention and treatment trial

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 in the interventions section below to request a patient information sheet.

Condition

Topic: Diabetes Research Network, Oral and Gastrointestinal; Subtopic: Type 2, Oral and Gastrointestinal (all Subtopics); Disease: Cardiovascular disease, Diabetic Control, Other, Oral & Dental

Intervention

1. Control group: usual periodontal care (supragingival scaling and polishing)
2. Test group: intensive periodontal therapy

Follow-up length: 12 months
Study entry: single randomisation only

Contact details for Patient Information Material:
Eastman Clinical Investigation Centre
256 Gray's Inn Road
London, WC1X 8LD
United Kingdom
Tel: +44 (0)20 7915 2334
Fax: +44 (0)20 7915 1213

Contact details for Study Principal Investigator:
Francesco D'Aiuto
UCL Eastman Dental Institute
Periodontology Unit
256 Grays Inn Road
London WC1X 8LD
United Kingdom
Email: f.daiuto@eastman.ucl.ac.uk

Contact details for Chief Investigator:
Professor Nikos Donos
UCL Eastman Dental Institute
Periodontology Unit
256 Grays Inn Road
London WC1X 8LD
United Kingdom
Email: n.donos@eastman.ucl.ac.uk

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Change in HbA1c between test and control group after 12 months of completion of therapy

Secondary outcome measures

1. To assess the impact of extensive periodontal therapy on:
1.1. Markers of gingival wound healing
1.2. Assessment of endothelial function
1.3. Subclinical atherosclerosis
1.4. Systemic inflammation
1.5. Proteinuria
1.6. Microbiological differences
In individuals with type 2 diabetes compared to control
2. To assess changes in quality of life, both related to diabetes and oral health, after extensive periodontal therapy compared to control

Overall trial start date

01/11/2008

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subject aged over 18 years, either sex
2. Subject diagnosed with T2 diabetes mellitus
3. Subject consenting to the study
4. Subject with signs of active moderate to severe periodontitis (at least 20 periodontal pockets, probing pocket depth [PPD] greater than 4 mm and bleeding on probing)
5. Minimum of 15 teeth present

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 280; UK sample size: 280

Participant exclusion criteria

1. Pregnancy/lactation
2. Subjects on chronic treatment with phenytoin or cyclosporin
3. Subjects with known human immunodeficiency virus (HIV) or hepatitis (B, C) or uncontrolled systemic diseases (cardiovascular diseases including hypertension, liver, pulmonary diseases, end stage renal failure) and/or neoplasm
4. Subjects who require antibiotic coverage for periodontal procedures

Recruitment start date

01/11/2008

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Eastman Dental Institute
London
WC1X 8LD
United Kingdom

Sponsor information

Organisation

Eastman Dental Institute and Hospital, University College London (UK)

Sponsor details

256 Gray's Inn Road
London
WC1X 8LD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.eastman.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Diabetes UK (UK) (ref: bda08/0003594)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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