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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by:
Radboud University

Tracking Information
First Submitted Date  ICMJE February 1, 2006
First Posted Date  ICMJE February 2, 2006
Last Update Posted Date July 27, 2007
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 3D Imaging of Hard and Soft Tissue in Orthognathic Surgery
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Craniofacial Abnormalities
  • Maxillofacial Abnormalities
  • Cleft Lip
  • Cleft Palate
Intervention  ICMJE
  • Procedure: 3D stereophotogrammetric imaging
  • Procedure: 3D CT-imaging with cone-beam CT
  • Procedure: Case report form
Study Arms  ICMJE Not Provided
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 1, 2006)
450
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • < 15 years
  • History of Orthognathic surgery
  • Not Caucasian
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00285714
Other Study ID Numbers  ICMJE 3D_MKC590_JP01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stefaan J Bergé, Prof, MD, DMD, PhD, Radboud University
Principal Investigator: Filip AC Schutyser, MsC Radboud University
PRS Account Radboud University
Verification Date July 2007

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