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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01473745
First received: November 15, 2011
Last updated: August 26, 2014
Last verified: August 2011
  Purpose

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

Condition Intervention Phase
Conditions in T74.31 or T76.31
Procedure: conventional nasal alar cinch suture technique
Procedure: modified extraoral alar base cinch technique
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Nasal Changes Affected by 2 Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy--A Randomized Controlled Trial

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Soft and Hard Tissue Landmarks Movement [ Time Frame: up to post-operation 4-6 weeks ] [ Designated as safety issue: Yes ]

    The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 1 month 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:
  • 14 Nasolabial Linear Parameters [ Time Frame: up to post-operation 6 months ] [ Designated as safety issue: Yes ]
    1. baseline characteristics: intercanthulus distance
    2. nasal linear parameters
    3. nasolabial linear parameters

  • 1 Nasolabial Angular Parameters [ Time Frame: up to post-operation 6 months ] [ Designated as safety issue: Yes ]
    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®)


Enrollment: 48
Study Start Date: July 2011
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: modified alar cinch suture
modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side
Procedure: modified extraoral alar base cinch technique
modified alar cinch suture technique performed after the maxillary Lefort I osteotomy.
Other Name: modified extraoral alar base cinch technique
Placebo Comparator: conventional alar base cinch suture
conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally
Procedure: conventional nasal alar cinch suture technique
conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy.
Other Name: conventional nasal alar cinch suture

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473745

Locations
Taiwan
Chang Gung memorial hospital
Taipei, Taiwan, 333
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01473745     History of Changes
Other Study ID Numbers: CGMH-100-1653A3, ChangGungMH
Study First Received: November 15, 2011
Results First Received: August 6, 2014
Last Updated: August 26, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
LeFort I osteotomy; Alar Base Cinch Suture; Nasolabial Change; 3-dimensional stereogrammetry

ClinicalTrials.gov processed this record on October 23, 2014