3D Imaging of Hard and Soft Tissue in Orthognathic Surgery - Full Text View

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

Genetics Home Reference related topics:

Cleft Lip and Palate Facial Injuries and Disorders Head and Brain Malformations

MedlinePlus related topics:

Ataxia Telangiectasia Cleft Lip and Palate Facial Injuries and Disorders Surgery

U.S. FDA Resources

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.

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

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

Study placed in the following topic categories:

Mouth Diseases

Cleft Palate

Facies

Cleft Lip

Craniofacial Abnormalities

Maxillofacial Abnormalities

Musculoskeletal Abnormalities

Additional relevant MeSH terms:

Musculoskeletal Diseases

Mouth Abnormalities

Jaw Diseases

Stomatognathic System Abnormalities

Jaw Abnormalities

Stomatognathic Diseases

Congenital Abnormalities

Lip Diseases

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	Radboud University
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00285714