Condition category
Oral Health
Date applied
27/10/2010
Date assigned
27/10/2010
Last edited
29/08/2014
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

Prof Tara Renton

ORCID ID

Contact details

King's College London Dental Institute
Denmark Hill Campus
Bessemer Road
London
SE5 9RS
United Kingdom
+44 (0)20 3299 2313
tara.renton@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6829

Study information

Scientific title

Acronym

Study hypothesis

Key research questions include: to assess if functional magnetic resonance imaging (fMRI) changes correlate with patient's expressed dental pain (Visual Analogue Scale [VAS]); and to identify what genes are associated with human pain expression and behaviour in acute post-surgical pain in man.

Ethics approval

MREC approved, ref: 07/H0808/115

Study design

Multicentre non-randomised observational diagnosis and screening study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Oral & Dental

Intervention

Surgery is undertaken along with MRI scanning and blood tests and psychometric tests.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Whole brain resting state distribution of Cerebral Blood Flow (rCBF) using continuous labelled ASL with multi-shot fast spin echo (FSE).

Secondary outcome measures

1. Cognitive Coping Strategizing Inventory (CCSI) index
2. Center for Epidemiologic Studies Depression Scale (CES-D) score
3. Computerised Visual Analogue Scale (VAS) measures of perceived intensity of post-surgical pain
4. DNA chip analysis blood
5. DNA chip analysis tissue
6. Eysenck Personality Questionnaire - revised version (EPQ-R) 'E (Extraversion)' and 'N (Neuroticism or Emotionality)' scores
7. Immunohistochemical analysis of known pain receptors
8. Schedule for Clinical Assessment in Neuropsychiatry (SCAN) score
9. The Symptom Checklist-90 - Revised (SCL-90-R) score
10. Students' Test Anxiety Questionnaire (STAQ) pre- and post-trait anxiety and state anxiety score
11. Surgical outcome (difficulty score [1 - 4 scale], depth of impaction, surgery time)

Overall trial start date

01/11/2007

Overall trial end date

01/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned sample size: 45

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2007

Recruitment end date

01/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London Dental Institute
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College Hospital NHS Foundation Trust (UK)

Sponsor details

Department of Research and Development KCH
34 Love Walk
London
SE5 8AD
United Kingdom

Sponsor type

Government

Website

http://www.kch.nhs.uk/

Funders

Funder type

Industry

Funder name

Pfizer Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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