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3D Craniofacial Cephalometric Analysis (ACRO3D)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Olszewski, Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01413373
First Posted: August 10, 2011
Last Update Posted: October 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Olszewski, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  Purpose
Development of three-dimensional craniofacial cephalometric analysis for virtual planning in orthognathic surgery.

Condition Intervention
Malocclusion Radiation: cone beam computed tomography Radiation: computer tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Validation of the Three-dimensional Computer Tomography Based Craniofacial Cephalometric Analysis

Further study details as provided by Olszewski, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • topological description of maxillomandibular dysmorphosis (angles, distances) [ Time Frame: 2014 ]
    Anterior cranial base angle on three-dimensional CT recostruction of the skull (in degrees) Posterior cranial base angle on three-dimensional CT recostruction of the skull (in degrees) Ratio between distance from nasion to anterior nasal spine/anterior nasal spine to chin landmark (without unit of maesurment) Measurements between various anatomic landmarks for orbits and maxillary sinus structures on the three-dimensional CT reconstruction of the patient's skull (in mm).


Estimated Enrollment: 15
Study Start Date: August 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: three-dimensional cephalometry
3D cephalometry performed on CBCT imaging
Radiation: cone beam computed tomography
A CBCT is performed for all patients in this study
Other Name: medical imaging, CBCT
Radiation: computer tomography
One computer tomography examination before surgery
Other Name: medical imaging

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • maxillomandibular dysmorphoses,
  • facial asymmetry,
  • craniofacial syndromes

Exclusion Criteria:

  • patients with orthodontic treatment only
  • growing patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413373


Contacts
Contact: Rapahel Olszewski, DDS,MD,PhD 003227645718 ext 5718 raphael.olszewski@uclouvain.be

Locations
Belgium
Department of oral and maxillofacial surgery, Cliniques universitaires saint Luc Recruiting
Brussels, Belgium, 1200
Contact: Raphael Olszewski, DDS,MD,PhD    003227645718    raphael.olszewski@uclouvain.be   
Principal Investigator: Raphael Olszewski, MD,PhD         
Principal Investigator: Hervé Reychler, MD,DMD,Pr         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Raphael Olszewski, DDS,MD,PhD Department of Oral and maxillofacial surgery, Cliniques Universitaires saint Luc
  More Information

Responsible Party: Olszewski, Professor, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01413373     History of Changes
Other Study ID Numbers: B40320083938
First Submitted: July 20, 2011
First Posted: August 10, 2011
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by Olszewski, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
cephalometry
three-dimensional
CT scan
lateral radiography
facial symmetry
maxillomandibular dysmorphoses

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases