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3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

This study is not yet open for patient recruitment

Verified by Radboud University February 2006

Sponsored by: Radboud University
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00285714


Purpose

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.


Condition Intervention
Craniofacial Abnormalities
Maxillofacial Abnormalities
Cleft Lip
Cleft Palate
Procedure: 3D stereophotogrammetric imaging
Procedure: 3D CT-imaging with cone-beam CT
Procedure: Case report form

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

Further study details as provided by Radboud University:
Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  450

Study start: February 2006;  Expected completion: December 2011
Last follow-up: December 2010;  Data entry closure: July 2011

Eligibility

Ages Eligible for Study:  15 Years and above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00285714

Joanneke Plooij, MD      +31-24-3619464    j.plooij@mkc.umcn.nl
Thomas Maal, MsC      +31-24-3614845    t.maal@mkc.umcn.nl

Netherlands
Radboud University Nijmegen Medical Centre, Nijmegen,  6500 HB,  Netherlands
Joanneke Plooij, MD  +31-24-3619464    j.plooij@mkc.umcn.nl 
Joanneke Plooij, MD,  Sub-Investigator
Filip Schutyser, MsC,  Principal Investigator

Rijnstate Hospital, Arnhem,  6815 AD,  Netherlands
Th.J.M. Hoppenreijs, Dr.  +31-26-3787434 
Th.J.M. Hoppenreijs, MD, DMD, PhD,  Principal Investigator

Hospital Gelderse Vallei, Ede,  6716 RP,  Netherlands
P.J. Van Strijen, Dr.  +31-318-435140 
P.J. Van Strijen, MD, DMD, PhD,  Principal Investigator

Study chairs or principal investigators

Stefaan J Bergé, Prof, MD, DMD, PhD,,  Study Director,  Radboud University   
Filip AC Schutyser, MsC,  Principal Investigator,  Radboud University   

More Information

Study ID Numbers:  3D_MKC590_JP01
Last Updated:  February 1, 2006
Record first received:  February 1, 2006
ClinicalTrials.gov Identifier:  NCT00285714
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2006-09-29





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