Phase 3
N=48
The Nasal Changes Affected by Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy
Conditions in T74.31 or T76.31
Bottom Line
View on ClinicalTrials.gov: NCT01473745 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Soft and Hard Tissue Landmarks Movement — 0.95; -0.5; -0.95; -0.32 mm — p=0.098
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- conventional alar base cinch (Procedure); modified alar base cinch (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Soft and Hard Tissue Landmarks Movement |
0.95; -0.5; -0.95; -0.32; 0.50; -0.71 | 0.098 |
| SECONDARY 14 Nasolabial Linear Parameters |
0.04; -0.62; 0.78; -0.80; 0.38; -0.81 | 0.218 |
| SECONDARY 1 Nasolabial Angular Parameters |
3.25; 2.92 | 0.104 |
Summary
study hypothesis
1. The aim of this study:
How can the investigators predict and control the nasal changes after maxillary LeFort I osteotomy with 2 different alar base suture techniques ?
2. Study hypothesis
* Null hypothesis: Nasal changes were not affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
* Alternative : Nasal changes were affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
Eligibility Criteria
Inclusion Criteria
- Taiwanese patients who received LeFort I osteotomy at CGMH during 2011-2012
- No previous craniofacial surgery
- Patients agreed to attend this study and willing to sign the agreement
- Patients who are elder than 18 years old and after growth completion
Exclusion Criteria
- Craniofacial anomalies
- cleft lip and /or palate patients
- patients without all the documents
- patients do not receive combined correcting nasolabial shape and orthognathic surgery.
Data sourced from ClinicalTrials.gov (NCT01473745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.