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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Conditions in T74.31 or T76.31

Treatments: Procedure: conventional alar base cinch; Procedure: modified alar base cinch

Study type: Interventional

Funder types: Other

Identifiers

NCT01473745

CGMH-100-1653A3

ChangGungMH (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

modified alar base cinch suture

Active Comparator group

Description:

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.

Treatment:

Procedure: modified alar base cinch

conventional alar base cinch suture

Placebo Comparator group

Description:

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.

Treatment:

Procedure: conventional alar base cinch