3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

This study is currently recruiting participants.

Verified by Radboud University, July 2007

First Received: February 1, 2006 Last Updated: 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:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: Baller-Gerold syndrome Crouzon syndrome

MedlinePlus related topics: Ataxia Telangiectasia Cleft Lip and Palate Facial Injuries and Disorders Surgery

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
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
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

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

Study ID Numbers:	3D_MKC590_JP01
Study First Received:	February 1, 2006
Last Updated:	July 26, 2007
ClinicalTrials.gov Identifier:	NCT00285714 History of Changes
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:

Mouth Diseases
Cleft Lip
Craniofacial Abnormalities
Jaw Diseases
Stomatognathic System Abnormalities
Maxillofacial Abnormalities
Lip Diseases

Musculoskeletal Abnormalities
Cleft Palate
Musculoskeletal Diseases
Mouth Abnormalities
Jaw Abnormalities
Stomatognathic Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 05, 2009