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 |
| Protocol serial number | N0205182186 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Barts and The London NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 01/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Shirley A Cox
Scientific
Scientific
Orthodontics
The Dental Hospital, 2nd Floor Room 215
New Road
Whitechapel
London
E1 1BB
United Kingdom
| Phone | +44 020 7377 7397 |
|---|---|
| shirley.cox@bartsandthelondon.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 18/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Orthodontics
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
