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
Type
Scientific
Additional contact
Dr Francesco D'Aiuto
ORCID ID
Contact details
Study Principal Investigator
UCL Eastman Dental Institute
Periodontology Unit
256 Grays Inn Road
London
WC1X 8LD
United Kingdom
-
f.daiuto@eastman.ucl.ac.uk
Type
Scientific
Additional contact
Prof Nikos Donos
ORCID ID
Contact details
Chief Investigator
UCL Eastman Dental Institute
Periodontology Unit
256 Grays Inn Road
London
WC1X 8LD
United Kingdom
-
n.donos@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.
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
Participants will be randomly assigned to either usual periodontal care (supragingival scaling and polishing) or to an intensive periodontal treatment (test group). Blood samples will be collected at almost every visit to assess glucose control between study groups. Samples will also be collected 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. Study follow-up is at 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
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
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