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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00014853 |
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Date of registration:
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29/06/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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CT database for evaluation of automatic image segmentation programs in the maxillofacial area
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Scientific title:
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CT database for evaluation of automatic image segmentation programs in the maxillofacial area - enFacedDB |
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Date of first enrolment:
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01/08/2018 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00014853 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Name:
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Jürgen
Wallner |
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Address:
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Auenbruggerplatz 5/1
8036
Graz
Austria |
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Telephone:
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+43/316/385-12428 |
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Email:
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j.wallner@medunigraz.at |
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Affiliation:
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Medizinische Universität Graz |
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Name:
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Jürgen
Wallner |
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Address:
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Auenbruggerplatz 5/1
8036
Graz
Austria |
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Telephone:
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+43/316/385-12428 |
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Email:
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j.wallner@medunigraz.at |
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Affiliation:
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Medizinische Universität Graz |
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Key inclusion & exclusion criteria
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Inclusion criteria: Physiologically functional, complete maxillofacial bones
Exclusion criteria: • Implants or osteosynthesis material
• Age <18 Years
• Bone necrosis or pathologic-cystic changes of the bones
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dentofacial anomalies [including malocclusion]
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Other congenital malformations of skull and face bones
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Other disorders of bone density and structure
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Other and unspecified injuries of head
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S02
M85
Q75
S09
K10
K07
Z96
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Fracture of skull and facial bones
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Other diseases of jaws
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Presence of other functional implants
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Intervention(s)
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Group 1: Establishment of a CT database (CT, PET/CT etc.) of the maxillofacial area with datasets from the clinical routine for the comparative evaluation of multiple image- based computer programs and platforms.
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Primary Outcome(s)
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Comparison image based segmentation of maxillofacial CT- data between automatic (algorithm) vs. manual (clinical experts) at measurement point T by Hausdorff Distance (HD, voxel) and Dice Similarity Score (DSC, %).
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Secondary Outcome(s)
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Comparison image based segmentation of maxillofacial CT- data between automatic (algorithm) vs. manual (clinical experts) at measurement point T by Volume (V, mm3), Voxel (Vx, Number), time (t, min., sec.).
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Source(s) of Monetary Support
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Austrian Science Fund (FWF) KLI 678-B31: “enFaced: Virtual and Augmented Reality Training and Navigation Module for 3D-Printed Facial Defect Reconstructions” (PIs: Jürgen Wallner and Jan Egger)
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FWF
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Ethics review
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Status: Approved
Approval date: 14/06/2018
Contact:
ethikkommission@medunigraz.at
Ethikkommission der Medizinischen Universität Graz
(+43)316-38513928
ethikkommission@medunigraz.at
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