MedPath

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

Phase 2
Completed
Conditions
Conditions in T74.31 or T76.31
Interventions
Procedure: conventional alar base cinch
Procedure: modified alar base cinch
Registration Number
NCT01473745
Lead Sponsor
Chang Gung Memorial Hospital
Brief 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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
conventional alar base cinch sutureconventional alar base cinchBefore 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.
modified alar base cinch suturemodified alar base cinchBefore 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.
Primary Outcome Measures
NameTimeMethod
Soft and Hard Tissue Landmarks MovementThe hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.

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.

Secondary Outcome Measures
NameTimeMethod
14 Nasolabial Linear Parametersup to post-operation 6 months

1. baseline characteristics: intercanthulus distance

2. nasal linear parameters

3. nasolabial linear parameters

1 Nasolabial Angular Parametersup to post-operation 6 months

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®)

Trial Locations

Locations (1)

Chang Gung memorial hospital

🇨🇳

Taipei, Taiwan

© Copyright 2025. All Rights Reserved by MedPath