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

November 15, 2011
August 26, 2014
July 2011
December 2013   (final data collection date for primary outcome measure)
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.

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.
Complete list of historical versions of study NCT01473745 on ClinicalTrials.gov Archive Site
  • 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®)
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.
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Conditions in T74.31 or T76.31
  • 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
  • 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
  • Active Comparator: modified alar cinch suture
    modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side
    Intervention: Procedure: 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
    Intervention: Procedure: conventional nasal alar cinch suture technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01473745
CGMH-100-1653A3, ChangGungMH
Yes
Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Study Director: Ellen, Wen Ching Ko, DDS,MS Chang Gung MH
Principal Investigator: YiHsuan Chen, DDS, MS Chang Gung MH
Chang Gung Memorial Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP