Use of modified mandibular plate for fractured mandible.
| ISRCTN | ISRCTN17497519 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17497519 |
| Secondary identifying numbers | N0205132373 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 08/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
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
Contact information
Mr Janavikulam Thiruchelvam
Scientific
Scientific
The Royal London Hospital
Oral & Maxillofacial surgery
London
E1 1BB
United Kingdom
| Phone | +44 (0)7810444103 / (0)7748797442 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 1. Does the modified plate enhance the ease of placement, reduce the risk of damage to the roots of teeth, damage to the inferior dental nerve in the canal and the mental nerve? 2. Does it avoid the requirement to place two plates? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health: Oral medicine |
| Intervention | Randomised clinical trial. |
| Intervention type | Other |
| Primary outcome measure | 1. Ease of placement assessed by reduction in time of placement. 2. Reduction in the manipulation of mental nerve - assessed by sensory testing of the lip pre and post operation. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2003 |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 40 |
| Key inclusion criteria | 40 consecutive patients who have sustained a fractured mandible passing through the mental foramen are randomly allocated to have a standard plate and the modified plate. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Royal London Hospital
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Barts and The London NHS Trust (UK)
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 |
