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 |
| Secondary identifying numbers | N0080141034 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 23/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Geraldine Brown
Scientific
Scientific
SSR Orthodontics
Whipps Cross University Hospital Trust
Whipps Cross Road
London
E11 1NR
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Comparison of orthodontic and conventional wire IMF in the open and closed management of mandibular fractures: a two centre randomised trial |
| Study hypothesis | To compare orthodontic fixation treatment in jaw fractures. |
| Ethics approval(s) | Not provided at time of registration |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| 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 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
E11 1NR
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Whipps Cross University Hospital NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
