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

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

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

Study Overview

• Status: Completed
• Conditions: Conditions in T74.31 or T76.31
• Intervention / Treatment: Procedure: modified alar base cinch; Procedure: conventional alar base cinch

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.; Other Names: modified alar base cinch technique
PLACEBO_COMPARATOR: 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.	Procedure: 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.; Other Names: conventional alar cinch suture technique

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Ellen, Wen Ching Ko, DDS,MS, Chang Gung MH; Principal Investigator: YiHsuan Chen, DDS, MS, Chang Gung MH

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (ESTIMATE): November 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 4, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Alar Base Suture; Nasolabial Change; 3D stereogrammetry
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Growth Substances; Plant Growth Regulators; Daminozide
• Other Study ID Numbers: CGMH-100-1653A3; ChangGungMH (Other Identifier: ChangGungMH)