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

First Received on February 1, 2006. Last Updated on July 26, 2007 History of Changes

Sponsor:	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:	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 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:

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 February 12, 2012