The Nasal Changes Affected by Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy

Study Overview
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Brief Summary
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study hypothesis 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 ? 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

Detailed Description
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Background and study purpose: Patients who received maxillary LeFort I osteotomy often complained about their nose become wider and more nostril show after surgery. According the the literature review, the conventional and modified alar base cinch technique both could control the interalar width. However, there is no long term result show which technique is superior to the other. Therefore, in order to improve patients' nasal and midfacial esthetics after the surgery, this study is to evaluate how the nasal changes affected by 2 different alar base cinch suture and which technique could result in a more positive effect.

Official Title
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The Nasal Changes Affected by 2 Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy--A Randomized Controlled Trial

Conditions
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Conditions in T74.31 or T76.31

Intervention / Treatment
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* Procedure: conventional alar base cinch
* Procedure: modified alar base cinch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: modified alar base cinch suture<br>Before closure of the maxillary wound, an alar base cinch suture was performed with 3-O Nylon. The modified alar cinch suture began from the bilateral alar part of the nasalis muscle and dermis tissue over the alar base, and then passed through a hole drilled on the anterior nasal spine. | Procedure: modified alar base cinch<br>* The modified suture began from the bilateral alar part of the nasalis muscle and dermis tissue over the alar base, and then passed through a hole drilled on the anterior nasal spine.<br>* Other names: modified alar base cinch technique;|
| Placebo Comparator: conventional alar base cinch suture<br>Before closure of the maxillary wound, an alar base cinch suture was performed with 3-O Nylon. The conventional alar base cinch suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine. | Procedure: conventional alar base cinch<br>* The conventional suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine.<br>* Other names: conventional alar cinch suture technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft and Hard Tissue Landmarks Movement | The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 4-6 weeks maxillary LeFort I osteotomy. The movement (6 months minus baseline) of soft tissue landmarks was measured before and after 6 months of the maxillary LeFort I osteotomy. The 3D directional movement of each point was measured in the x(transverse), y(vertical), and z (antero-posterior)planes. The positive directional movement of each point in X axis means the point moved left after surgery, and negative directional movement in X axis means the the point moved right after surgery. The positive directional movement in Y axis means the point moved upward after surgery, and negative directional movement in Y axis means the the point moved downward after surgery. The positive directional movement in Z axis means the point moved anteriorly after surgery, and negative directional movement in Z axis means the the point moved posteriorly after surgery. | The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 14 Nasolabial Linear Parameters | baseline characteristics: intercanthulus distance nasal linear parameters nasolabial linear parameters | up to post-operation 6 months | 
| 1 Nasolabial Angular Parameters | 2D nasolabial angular parameter: Nasolabial angle (NLA) (The NLA was a two dimensional measurement and was measured at the midsagittal plane with Image J software®) | up to post-operation 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alar Base Suture; Nasolabial Change; 3D stereogrammetry