3D Craniofacial Cephalometric Analysis (ACRO3D)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014