Eliminating periodontal infection in patients with type 2 diabetes

ISRCTN	ISRCTN57210949
DOI	https://doi.org/10.1186/ISRCTN57210949
Secondary identifying numbers	4678

Submission date: 21/05/2010
Registration date: 21/05/2010
Last edited: 13/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Kerry Stone
Scientific

School of Dental Sciences
Framlington Place
Newcastle upon Tyne
NE2 4BW
United Kingdom

Email	kerry.stone@ncl.ac.uk

Study information

Study design	Single centre non-randomised observational diagnosis and treatment study
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Eliminating periodontal infection in patients with type 2 diabetes: a single centre non-randomised observational diagnosis and treatment study
Study acronym	DRN149 (DDP)
Study objectives	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(s)	MREC approved on the 28th February 2006 (ref: 06/Q0904/8)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2006
Completion date	30/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Planned sample size: 160; UK sample size: 160
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2006
Date of final enrolment	30/03/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Dental Sciences

Newcastle upon Tyne
NE2 4BW
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

Website	http://www.newcastle-hospitals.org.uk/
"ROR"	https://ror.org/05p40t847

Funders

Funder type

Charity

Dunhill Medical Trust (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): The Dunhill Medical Trust, DMT
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/12/2019: No publications found, verifying study status with principal investigator.
21/07/2016: No publications found, verifying study status with principal investigator