3D Craniofacial Cephalometric Analysis (ACRO3D)

July 12, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Department of oral and maxillofacial surgery, Cliniques universitaires saint Luc
        • Contact:
        • Principal Investigator:
          • Raphael Olszewski, MD,PhD
        • Principal Investigator:
          • Hervé Reychler, MD,DMD,Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient more than 18 yeras old, no pregnant women, no child

Description

Inclusion Criteria:

  • maxillomandibular dysmorphoses,
  • facial asymmetry,
  • craniofacial syndromes

Exclusion Criteria:

  • patients with orthodontic treatment only
  • growing patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (Estimate)

August 10, 2011

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B40320083938
  • 2014/13MAR/104 (Other Identifier: CEHF)
  • MAXILLARY SEPTA 3D (Other Identifier: CLAIRE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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