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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: October 28, 2014
Last verified: August 2011
Results First Received: August 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Conditions in T74.31 or T76.31
Interventions: Procedure: conventional alar base cinch
Procedure: modified alar base cinch

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All nongrowing Taiwanese patients over 18 years of age who underwent LeFort I maxillary osteotomy to correct skeletal discrepancies were randomly selected to receive either conventional or modified alar base cinching during the intraoral wound closing procedure.The recruitment duration was September of 2011 to February of 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria: Patients with an associated syndromic diagnosis, cleft of the lip or palate, dentofacial trauma, and previous nasal septum or nasal tip operations. 10 non-Class III patients were further excluded for enhanced sample consistency, 2 patients refused to participate were also excluded. Thus, total sample size was 48 patients.

Reporting Groups
  Description
Conventional Alar Cinch Group Patients received conventional alar base cinch technique during LeFort I osteotomy procedure.
Modified Alar Cinch Group Patients received modified alar base cinch technique during LeFort I osteotomy procedure.

Participant Flow:   Overall Study
    Conventional Alar Cinch Group     Modified Alar Cinch Group  
STARTED     24     24  
COMPLETED     24     24  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Taiwanese Class III patients

Reporting Groups
  Description
Modified Alar Cinch Suture

modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side

modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy.

Conventional Alar Base Cinch Suture

conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally

conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy.

Total Total of all reporting groups

Baseline Measures
    Modified Alar Cinch Suture     Conventional Alar Base Cinch Suture     Total  
Number of Participants  
[units: participants]
  24     24     48  
Age, Customized  
[units: years]
Mean ( Full Range )
     
Age     24.13  
  ( 19 to 57 )  
  23.78  
  ( 18 to 34 )  
  23.92  
  ( 18 to 57 )  
Gender  
[units: participants]
     
Female     17     18     35  
Male     7     6     13  
Race/Ethnicity, Customized  
[units: participants]
     
Taiwanese     24     24     48  
Region of Enrollment  
[units: participants]
     
Taiwan     24     24     48  



  Outcome Measures
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1.  Primary:   Soft and Hard Tissue Landmarks Movement   [ Time Frame: The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months. ]

2.  Secondary:   14 Nasolabial Linear Parameters   [ Time Frame: up to post-operation 6 months ]

3.  Secondary:   1 Nasolabial Angular Parameters   [ Time Frame: up to post-operation 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Yi Hsuan Chen
Organization: ChangGungMH
phone: +886227135211 ext 3533
e-mail: acantehr@gmail.com


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: October 28, 2014
Health Authority: Taiwan: Institutional Review Board