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

ISRCTN	ISRCTN31051582
DOI	https://doi.org/10.1186/ISRCTN31051582
Protocol serial number	N0080141034
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Whipps Cross University Hospital NHS Trust (UK), NHS R&D Support Funding

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

Dr Geraldine Brown
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Comparison of orthodontic and conventional wire IMF in the open and closed management of mandibular fractures: a two centre randomised trial
Study objectives	To compare orthodontic fixation treatment in jaw fractures.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/06/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Key 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.
Key exclusion criteria	Under 16, pre-existing dental disease, multiple facial fractures, upper jaw fractures, alveolar fractures.
Date of first enrolment	01/06/2004
Date of final enrolment	01/06/2006

SSR Orthodontics

London
E11 1NR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan