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

This study is currently recruiting participants.

Verified August 2011 by Chang Gung Memorial Hospital

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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 15, 2011

Last Updated Date

November 16, 2011

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01473745 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

study hypothesis

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 ?
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

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 ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Conditions in T74.31 or T76.31

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01473745

Other Study ID Numbers ^ICMJE

CGMH-100-1653A3, ChangGungMH

Has Data Monitoring Committee

Yes

Responsible Party

Chang Gung Memorial Hospital

Study Sponsor ^ICMJE

Chang Gung Memorial Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ellen, Wen Ching Ko, DDS

Chang Gung MH

Information Provided By

Chang Gung Memorial Hospital

Verification Date

August 2011

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

To Top