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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38986023
Enrollment
64
Registered
2007-09-28
Start date
2006-04-19
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery: Dentofacial anomalies [including malocclusion] Surgery Dentofacial anomalies [including malocclusion]

Interventions

Experimental group will have a clinch suture placed during their operative procedure. Control group will not.

Sponsors

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

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026