3D Craniofacial Cephalometric Analysis

Malocclusion Clinical Trial

— ACRO3D  

Official title:

Clinical Validation of the Three-dimensional Computer Tomography Based Craniofacial Cephalometric Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01413373
• Other study ID #: B40320083938
• Secondary ID: 2014/13MAR/104MA
• Status: Recruiting
• Start date: August 2008
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Rapahel Olszewski, DDS,MD,PhD
• Phone: 003227645718
• Email: raphael.olszewski[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Development of three-dimensional craniofacial cephalometric analysis for virtual planning in orthognathic surgery.

Description:

Cone beam computed tomography is taken for diagnosis independently from this study. Investigators are using this medical imaging for performing the 3D cephalometric analysis. Investigators apply a set of well described landmarks of three-dimensional reconstruction of the skull from patients suffering from diverse craniofacial malformations. Then a set of specific measurements is taken from the patient and provide insights how to modify the anatomy of the patient to improve the skull's architecture and symmetry

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• maxillomandibular dysmorphoses,

• facial asymmetry,

• craniofacial syndromes

Exclusion Criteria:

• patients with orthodontic treatment only

• growing patients

Related Conditions & MeSH terms

• Malocclusion

Intervention

Radiation:
• cone beam computed tomography
A preoperative CBCT is performed for all patients in this study for medical reason
• computer tomography
One cone beam computer tomography examination before surgery

Locations

Country	Name	City	State
Belgium	Department of oral and maxillofacial surgery, Cliniques universitaires saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	topological description of maxillomandibular dysmorphosis (angles, distances)	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).	2014