Status:

UNKNOWN

Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial

Lead Sponsor:

Chang Gung Memorial Hospital

Conditions:

Surgical Procedure, Unspecified

Eligibility:

All Genders

16+ years

Phase:

NA

Brief Summary

Objectives: The aims of this study are (1) to define the effectiveness of functional nasal surgery during Le Fort I osteotomy on nasal obstruction through objective as well as subjective evaluations, ...

Eligibility Criteria

Inclusion

  • Taiwanese adults with dentofacial deformities (DFD)
  • Have documented nasal obstruction and a hypertrophied inferior turbinate on the contralateral side of the septal deviation
  • Will undergo bimaxillary surgery including 1-piece Le Fort I osteotomy for DFD at the Craniofacial Center between 2012 and 2013

Exclusion

  • Previous OGS or nasal surgery
  • Patients with nasal polyposis, rhinosinusitis or neoplasia
  • Patients with clefts or craniofacial anomaly
  • Patients with adenoid hypertrophy, nasal valve collapse, uncontrolled asthma or tobacco use
  • Noncompliance for test
  • Noncompliance to test schedule
  • Won't sign informed consent

Key Trial Info

Start Date :

June 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2017

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT01883687

Start Date

June 1 2013

End Date

April 1 2017

Last Update

June 21 2013

Active Locations (1)

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1

Chang Gung Memorial Hospital

Taoyuan District, Taiwan