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
NetherlandsRadboud 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:
NCT00285714Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) ClinicalTrials.gov processed this record on 2006-09-29 |
