3D Craniofacial Cephalometric Analysis (ACRO3D)

This study is currently recruiting participants.
Verified October 2012 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor:
Information provided by (Responsible Party):
Olszewski, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01413373
First received: July 20, 2011
Last updated: October 15, 2012
Last verified: October 2012
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Validation of the Three-dimensional Computer Tomography Based Craniofacial Cephalometric Analysis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • topological description of maxillomandibular dysmorphosis (angles, distances) [ Time Frame: 2014 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Olszewski, Professor, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01413373     History of Changes
Other Study ID Numbers: B40320083938
Study First Received: July 20, 2011
Last Updated: October 15, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on April 22, 2014