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3D Imaging of Hard and Soft Tissue in Orthognathic Surgery
This study is currently recruiting participants.
Study NCT00285714   Information provided by Radboud University
First Received: February 1, 2006   Last Updated: July 26, 2007   History of Changes

February 1, 2006
July 26, 2007
February 2006
 
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.
Same as current
Complete list of historical versions of study NCT00285714 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
3D Imaging of Hard and Soft Tissue in Orthognathic Surgery
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.

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.

 
 
Interventional
Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Craniofacial Abnormalities
  • Maxillofacial Abnormalities
  • Cleft Lip
  • Cleft Palate
  • Procedure: 3D stereophotogrammetric imaging
  • Procedure: 3D CT-imaging with cone-beam CT
  • Procedure: Case report form
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
450
December 2010
 

Inclusion Criteria:

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

Exclusion Criteria:

  • < 15 years
  • History of Orthognathic surgery
  • Not Caucasian
Both
15 Years and older
No
Contact: Joanneke Plooij, MD +31-24-3619464 j.plooij@mka.umcn.nl
Contact: Thomas Maal, MsC +31-24-3614845 t.maal@mka.umcn.nl
Netherlands
 
NCT00285714
 
3D_MKC590_JP01
Radboud University
 
Study Director: Stefaan J Bergé, Prof, MD, DMD, PhD, Radboud University
Principal Investigator: Filip AC Schutyser, MsC Radboud University
Radboud University
July 2007

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