3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00285714
First received: February 1, 2006
Last updated: July 26, 2007
Last verified: July 2007
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 450
Study Start Date: February 2006
Estimated Study Completion Date: December 2010
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285714

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

No publications provided

ClinicalTrials.gov Identifier: NCT00285714     History of Changes
Other Study ID Numbers: 3D_MKC590_JP01
Study First Received: February 1, 2006
Last Updated: July 26, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
3D computer assisted imaging
maxillofacial surgery
cephalometry
normative value

Additional relevant MeSH terms:
Congenital Abnormalities
Cleft Lip
Cleft Palate
Craniofacial Abnormalities
Maxillofacial Abnormalities
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014