Condition category
Injury, Occupational Diseases, Poisoning
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
23/04/2015
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

Dr Geraldine Brown

ORCID ID

Contact details

SSR Orthodontics
Whipps Cross University Hospital Trust
Whipps Cross Road
London
E11 1NR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0080141034

Study information

Scientific title

Comparison of orthodontic and conventional wire IMF in the open and closed management of mandibular fractures: a two centre randomised trial

Acronym

Study hypothesis

To compare orthodontic fixation treatment in jaw fractures.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Injury, Occupational Diseases, Poisoning: Mandibular fractures

Intervention

Patients randomised into 2 groups: open or closed management of fracture using two different type of fixings, patient satisfaction questionnaire/VAS pain scores.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

To evaluate the two forms of treatment for cost benefit to the NHS.
Outcome measures: theatre time, length of stay, amount of follow up, patient satisfaction and pain experienced.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2004

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

150 patients 75 from this site. Included are all patients with a mandibular lower jaw fracture, over 16, no pre-existing dental disease, attending Whipps Cross NHS or Barts and the London NHS Trust.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Under 16, pre-existing dental disease, multiple facial fractures, upper jaw fractures, alveolar fractures.

Recruitment start date

01/06/2004

Recruitment end date

01/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

SSR Orthodontics
London
E11 1NR
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Whipps Cross University Hospital NHS Trust (UK), NHS R&D Support Funding

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