| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN17497519 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0205132373 |
| Public title | Use of modified mandibular plate for fractured mandible. |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Oral Health: Oral medicine |
| Study hypothesis | 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 01/10/2003 |
| Anticipated end date | 01/09/2006 |
| Status of trial | Completed |
| Target number of participants | 40 |
| Interventions | Randomised clinical trial. |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | Barts and The London NHS Trust (UK) |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Janavikulam Thiruchelvam |
| Contact details | The Royal London Hospital
Oral & Maxillofacial surgery
London
United Kingdom
E1 1BB |
| Contact telephone | +44 (0)7810444103 / (0)7748797442 |
| Contact fax | +44 (0)207 377 7095 |
| Contact email | janavikulam.thiruchelvam@bartsandthelondon.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN17497519 |
| Date last extracted from ISRCTN register | 17/04/2008 |
