3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

• ClinicalTrials.gov Identifier: NCT00285714
• Recruitment Status: Unknown
• First Posted: February 2, 2006
• Last Update Posted: July 27, 2007
• Sponsor: Radboud University
• Information provided by: Radboud University

Tracking Information

• First Submitted Date: February 1, 2006
• First Posted Date: February 2, 2006
• Last Update Posted Date: July 27, 2007
• Study Start Date: February 2006
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: February 1, 2006): 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.
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 1, 2006)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Craniofacial Abnormalities
• Maxillofacial Abnormalities
• Cleft Lip
• Cleft Palate

Intervention

• Procedure: 3D stereophotogrammetric imaging
• Procedure: 3D CT-imaging with cone-beam CT
• Procedure: Case report form

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 1, 2006): 450
• Original Enrollment: Same as current
• Estimated Study Completion Date: December 2010
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00285714
• Other Study ID Numbers: 3D_MKC590_JP01
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Radboud University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Radboud University
• Verification Date: July 2007