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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Conditions in T74.31 or T76.31

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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modified alar base cinch suture

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.

Group Type ACTIVE_COMPARATOR

modified alar base cinch

Intervention Type PROCEDURE

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.

conventional alar base cinch suture

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.

Group Type PLACEBO_COMPARATOR

conventional alar base cinch

Intervention Type PROCEDURE

The conventional suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine.

Interventions

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conventional alar base cinch

The conventional suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine.

Intervention Type PROCEDURE

modified alar base cinch

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.

Intervention Type PROCEDURE

Other Intervention Names

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conventional alar cinch suture technique modified alar base cinch technique

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes