3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285714
Recruitment Status : Unknown
Verified July 2007 by Radboud University.
Recruitment status was:  Recruiting
First Posted : February 2, 2006
Last Update Posted : July 27, 2007
Information provided by:
Radboud University

February 1, 2006
February 2, 2006
July 27, 2007
February 2006
Not Provided
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 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
Not Provided
Not Provided
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.
Not Provided
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Craniofacial Abnormalities
  • Maxillofacial Abnormalities
  • Cleft Lip
  • Cleft Palate
  • Procedure: 3D stereophotogrammetric imaging
  • Procedure: 3D CT-imaging with cone-beam CT
  • Procedure: Case report form
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2010
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • < 15 years
  • History of Orthognathic surgery
  • Not Caucasian
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Radboud University
Not Provided
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