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3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

This study is currently recruiting participants.
Study NCT00285714.   Last updated on July 26, 2007.   Information provided by Radboud University

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Descriptive Information Fields
Brief Title  3D Imaging of Hard and Soft Tissue in Orthognathic Surgery
Official Title  An Analysis of the Clinical Applicability of a Three-Dimensional Imaging Platform Used to Register the Influence of Orthognathic Surgery on Facial Hard and Soft Tissue in Patients With Congenital Maxillofacial Deformities.
Brief Summary

The primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  All changes (volumetric, linear or angular) of facial hard and soft tissue caused by orthognathic surgery at 1 months, 6 months, 12 months and 24 months.
Secondary Outcome Measure  All postoperative changes in functionality at 1 year
patients' satisfaction of facial proportions at 1 year
surgeons' satisfaction of the 3D planning platform at 1 month
Condition  Craniofacial Abnormalities
Maxillofacial Abnormalities
Cleft Lip
Cleft Palate
Intervention  Procedure: 3D stereophotogrammetric imaging
Procedure: 3D CT-imaging with cone-beam CT
Procedure: Case report form
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  450
Start Date  February 2006
Completion Date December 2010
Eligibility Criteria 

Inclusion Criteria:

  • Dysgnathic deformity
  • Caucasian
  • > 15 years
  • No history of orthognathic surgery
  • Informed Consent

Exclusion Criteria:

  • < 15 years
  • History of Orthognathic surgery
  • Not Caucasian
Gender Both
Ages 15 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Joanneke Plooij, MD     +31-24-3619464     j.plooij@mka.umcn.nl    
Contact: Thomas Maal, MsC     +31-24-3614845     t.maal@mka.umcn.nl    
Location Countries  Netherlands
Administrative Information Fields
NCT ID  NCT00285714
Organization ID 3D_MKC590_JP01
Secondary IDs ††
Study Sponsor  Radboud University
Collaborators ††
Investigators 
Study Director:     Stefaan J Bergé, Prof, MD, DMD, PhD,     Radboud University    
Principal Investigator:     Filip AC Schutyser, MsC     Radboud University    
Information Provided By Radboud University
Verification Date July 2007
First Received Date  February 1, 2006
Last Updated Date July 26, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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