Use of modified mandibular plate for fractured mandible.

ISRCTN	ISRCTN17497519
DOI	https://doi.org/10.1186/ISRCTN17497519
Protocol serial number	N0205132373
Sponsor	Department of Health
Funder	Barts and The London NHS Trust (UK)

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

Mr Janavikulam Thiruchelvam
Scientific

The Royal London Hospital
Oral & Maxillofacial surgery
London
E1 1BB
United Kingdom

Phone	+44 (0)7810444103 / (0)7748797442

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/09/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

The Royal London Hospital

London
E1 1BB
United Kingdom

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