Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Primary outcome measure
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 study start date
01/06/2004
Overall study end date
01/06/2006
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
England, United Kingdom
Study 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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|