A prospective randomised clinical trial to assess change in nasal soft tissue dimensions in orthognathic surgery evaluated using a 3D imaging system

ISRCTN	ISRCTN38986023
DOI	https://doi.org/10.1186/ISRCTN38986023
Secondary identifying numbers	N0205182186

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Miss Shirley A Cox
Scientific

Orthodontics
The Dental Hospital, 2nd Floor Room 215
New Road
Whitechapel
London
E1 1BB
United Kingdom

Phone	+44 020 7377 7397
Email	shirley.cox@bartsandthelondon.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	To ascertain whether the alar base cinch suture is effective in controlling the width of the alar base of the nose following Le Fort 1 osteotomy by using a 3D imaging system.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Dentofacial anomalies [including malocclusion]
Intervention	Experimental group will have a clinch suture placed during their operative procedure. Control group will not.
Intervention type	Procedure/Surgery
Primary outcome measure	The amount of change in the width of the alar base of the nose, between control and experimental groups. We will take laser scans at the start and at the end of the treatment periods.
Secondary outcome measures	No secondary outcome measures
Overall study start date	19/04/2006
Completion date	18/07/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	64
Key inclusion criteria	1. Patients requiring a Le Fort 1 osteotomy to correct malocclusion 2. Patients concurrently undergoing a course of orthodontic fixed appliance therapy at the time of surgery
Key exclusion criteria	1. Patients have no previous history of facial trauma 2. Patients do not have a cleft lip and/or palate 3. Patients do not have a craniofacial abnormality 4. Patients are not undergoing a re-treatment procedure 5. Patients have not had previous facial soft tissue surgery 6. No children <16 years old
Date of first enrolment	19/04/2006
Date of final enrolment	18/07/2007

Orthodontics

London
E1 1BB
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Barts and The London NHS Trust (UK), NHS R&D Support Funding

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2011		Yes	No