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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Study Start Date : February 2006
Estimated Study Completion Date : December 2010

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. All postoperative changes in functionality at 1 year
  2. patients' satisfaction of facial proportions at 1 year
  3. surgeons' satisfaction of the 3D planning platform at 1 month

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285714


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

Locations
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Netherlands
Rijnstate Hospital Recruiting
Arnhem, Netherlands, 6815 AD
Contact: Th.J.M. Hoppenreijs, Dr.    +31-26-3787434      
Principal Investigator: Th.J.M. Hoppenreijs, MD, DMD, PhD         
Hospital Gelderse Vallei Recruiting
Ede, Netherlands, 6716 RP
Contact: P.J. Van Strijen, Dr.    +31-318-435140      
Principal Investigator: P.J. Van Strijen, MD, DMD, PhD         
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Joanneke Plooij, MD    +31-24-3619464    j.plooij@mka.umcn.nl   
Sub-Investigator: Joanneke Plooij, MD         
Principal Investigator: Filip Schutyser, MsC         
Sponsors and Collaborators
Radboud University
Investigators
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Study Director: Stefaan J Bergé, Prof, MD, DMD, PhD, Radboud University
Principal Investigator: Filip AC Schutyser, MsC Radboud University
More Information
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ClinicalTrials.gov Identifier: NCT00285714    
Other Study ID Numbers: 3D_MKC590_JP01
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: July 27, 2007
Last Verified: July 2007
Keywords provided by Radboud University:
3D computer assisted imaging
maxillofacial surgery
cephalometry
normative value
Additional relevant MeSH terms:
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Cleft Palate
Craniofacial Abnormalities
Maxillofacial Abnormalities
Cleft Lip
Congenital Abnormalities
Lip Diseases
Mouth Diseases
 Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities