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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: |
DRKS00014337 |
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Date of registration:
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04/05/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Klinische Evaluierung algorithmisch-semi-automatischer Open Source Software Segmentierung des Unterkiefers
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Scientific title:
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Klinische Evaluierung algorithmisch-semi-automatischer Open Source Software Segmentierung des Unterkiefers - enFaced |
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Date of first enrolment:
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01/04/2017 |
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Target sample size:
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10 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00014337 |
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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 lower jawbones
• Age =18 Years
• Age <99 Years
• Data due to the medical indication in the clinical diagnostic at the department of Oral and maxillofacial surgery
Exclusion criteria: • Implants or osteosynthesis material
• Age <18 Years
• Lower jawbone 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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bone fracture, bone defect
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Intervention(s)
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Group 1: Establishment of a CT database of the mandible with datasets from the clinical routine for the evaluation of an image-based computer program.
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Primary Outcome(s)
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Comparison image based segmentation of lower jaw 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 lower jaw 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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Fonds zur Förderung der wissenschaftlichen Forschung (FWF)
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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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Ethics review
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Status: Approved
Approval date: 03/02/2017
Contact:
ethikkommission@medunigraz.at
Ethikkommission der Medizinischen Universität Graz
(+43)316-38513928
ethikkommission@medunigraz.at
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