Contact information
Type
Scientific
Primary contact
Miss Kerry Stone
ORCID ID
Contact details
School of Dental Sciences
Framlington Place
Newcastle upon Tyne
NE2 4BW
United Kingdom
-
kerry.stone@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4678
Study information
Scientific title
Eliminating periodontal infection in patients with type 2 diabetes: a single centre non-randomised observational diagnosis and treatment study
Acronym
DRN149 (DDP)
Study hypothesis
Periodontal disease is emerging as a recognised complication of diabetes, and epidemiological data support that patients with type 2 diabetes mellitus (T2DM) have increased prevalence and severity of periodontitis. Furthermore, recent preliminary data suggest that diabetes control in patients with periodontitis may be improved following successful periodontal treatment.
In this study, we will perform a full periodontal examination and glycaemic control will be measured (HbA1c) in 160 T2DM individuals aged 30 - 55 years. For those patients who are diagnosed as having periodontal disease (estimated n = 40), we will treat their disease using established periodontal treatment methods to eliminate the periodontal infection. The patients will be monitored for 12 months following treatment and changes in HbA1c at months 3, 6 and 12 following treatment will be measured. We will also measure cytokine and adipokine levels in the gingival crevicular fluid (GCF), saliva and in serum, including interleukin-6 (IL-6) and tumour necrotising factor-alpha (TNF-alpha) in all patients at screening, and before and after treatment in those patients with periodontal disease to understand better the pathogenic processes common to both diseases. 40 controls (non-diabetic patients who have periodontal disease) will also be recruited.
This research will provide fundamental information on associations between periodontal inflammation and glycaemic control and will evaluate the effect of periodontal therapy on glycaemic control in T2DM patients with periodontal disease.
Ethics approval
MREC approved on the 28th February 2006 (ref: 06/Q0904/8)
Study design
Single centre non-randomised observational diagnosis and treatment study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Diabetes Research Network, Oral and Gastrointestinal, Primary Care Research Network for England; Subtopic: Type 2, Oral and Gastrointestinal (all Subtopics); Disease: Other, Oral & Dental
Intervention
Conventional periodontal therapy in patients with periodontal disease.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Serum HbA1c, lipid profile, high sensitivity C-reactive protein (hsCRP)
2. Inflammatory cytokines (IL-1b, TNF-a, IL-6, INF-y)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2006
Overall trial end date
30/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Planned sample size: 160; UK sample size: 160
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2006
Recruitment end date
30/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Dental Sciences
Newcastle upon Tyne
NE2 4BW
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Dunhill Medical Trust (UK)
Alternative name(s)
DMT
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