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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01473745
First received: November 15, 2011
Last updated: November 16, 2011
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: Safety/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:
  • nostril show at natural head position [ Time Frame: up to post-operation 6 months ] [ Designated as safety issue: Yes ]
    the investigators measure the differece of the nostril show surface area before and after 1 month and 6 months of the maxillary LeFort I osteotomy.


Secondary Outcome Measures:
  • nasal alar base width [ Time Frame: up to post-operation 6 months ] [ Designated as safety issue: Yes ]
    the investigators measure the differece of the alar base width before and after 1 month and 6 months of the maxillary LeFort I osteotomy.


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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 Recruiting
Taipei, Taiwan, 333
Contact: Ellen, Wen Ching Ko, Bachelar    +886-3196200 ext 2131    ellenko.wc@msa.hinet​.net   
Principal Investigator: Yi-Hsuan Chen, Bachelar         
Chang Gung Memorial Hospiral , Taipei and Tauyan Branch Recruiting
Taipei, Taiwan, 333
Contact: Yi-Hsuan Chen, Bachelar    +886-921-161-342    acantehr@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ellen, Wen Ching Ko, DDS 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
Last Updated: November 16, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
severe skeletal malocclusion

ClinicalTrials.gov processed this record on July 24, 2014