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| Descriptive Information Fields | |||||||||
| Brief Title † | 3D Imaging of Hard and Soft Tissue in Orthognathic Surgery | ||||||||
| 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. | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | 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 Measure † | 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 |
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| Condition † | Craniofacial Abnormalities Maxillofacial Abnormalities Cleft Lip Cleft Palate |
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| Intervention † | Procedure: 3D stereophotogrammetric imaging Procedure: 3D CT-imaging with cone-beam CT Procedure: Case report form |
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| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 450 | ||||||||
| Start Date † | February 2006 | ||||||||
| Completion Date | December 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 15 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Netherlands | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00285714 | ||||||||
| Organization ID | 3D_MKC590_JP01 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Radboud University | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Radboud University | ||||||||
| Verification Date | July 2007 | ||||||||
| First Received Date † | February 1, 2006 | ||||||||
| Last Updated Date | July 26, 2007 | ||||||||
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