Trial record 8 of 14 for:
Open Studies | "Cleft Palate"
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
Recruitment status was Recruiting
Sponsor:
Radboud University
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00285714
First received: February 1, 2006
Last updated: July 26, 2007
Last verified: July 2007
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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:
Genetics Home Reference related topics:
Baller-Gerold syndrome
branchio-oculo-facial syndrome
Crouzon syndrome
MedlinePlus related topics:
Cleft Lip and Palate
Craniofacial Abnormalities
Facial Injuries and Disorders
U.S. FDA Resources
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
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:
|
Cleft Palate Congenital Abnormalities Cleft Lip 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 May 22, 2013