Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
01/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Shirley A Cox

ORCID ID

Contact details

Orthodontics
The Dental Hospital
2nd Floor Room 215
New Road
Whitechapel
London
E1 1BB
United Kingdom
+44 020 7377 7397
shirley.cox@bartsandthelondon.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205182186

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

19/04/2006

Overall trial end date

18/07/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

64

Participant 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

Recruitment start date

19/04/2006

Recruitment end date

18/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthodontics
London
E1 1BB
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20304541

Publication citations

  1. Results

    Howley C, Ali N, Lee R, Cox S, Use of the alar base cinch suture in Le Fort I osteotomy: is it effective?, Br J Oral Maxillofac Surg, 2011, 49, 2, 127-130, doi: 10.1016/j.bjoms.2010.02.009.

Additional files

Editorial Notes