Condition category
Oral Health
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
21/07/2016
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

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

http://www.newcastle-hospitals.org.uk/

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

Publication citations

Additional files

Editorial Notes

21/07/2016: No publications found, verifying study status with principal investigator