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Note: This record shows only 21 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.
Register: German Clinical Trials Register
Last refreshed on: 5 December 2018
Main ID:  DRKS00014853
Date of registration: 29/06/2018
Prospective Registration: Yes
Primary sponsor: Medizinische Universität Graz
Public title: CT database for evaluation of automatic image segmentation programs in the maxillofacial area
Scientific title: CT database for evaluation of automatic image segmentation programs in the maxillofacial area - enFacedDB
Date of first enrolment: 01/07/2018
Target sample size: 100
Recruitment status: Pending
URL:  http://www.drks.de/DRKS00014853
Study type:  observational
Study design:  Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Other. Assignment: Parallel. Study design purpose: Basic research/physiological study;  
Phase:  N/A
Countries of recruitment
Austria
Contacts
Name: Jürgen    Wallner
Address:  Auenbruggerplatz 5/1 8036 Graz Austria
Telephone: +43/316/385-12428
Email: j.wallner@medunigraz.at
Affiliation:  Medizinische Universität Graz
Name: Jürgen    Wallner
Address:  Auenbruggerplatz 5/1 8036 Graz Austria
Telephone: +43/316/385-12428
Email: j.wallner@medunigraz.at
Affiliation:  Medizinische Universität Graz
Key inclusion & exclusion criteria
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: Both, male and female
Health Condition(s) or Problem(s) studied
K07 - Dentofacial anomalies [including malocclusion]
K10 - Other diseases of jaws
M85 - Other disorders of bone density and structure
Q75 - Other congenital malformations of skull and face bones
S02 - Fracture of skull and facial bones
S09 - Other and unspecified injuries of head
Z96 - Presence of other functional implants
Intervention(s)
Intervention 1: Establishment of a CT database of the maxillofacial area with datasets from the clinical routine for the comparative evaluation of multiple image- based computer programs and platforms. Intervention 2: Automatic maxillofacial bone segmentation with computer programs on CT data basis: time of measurement (T) with Hausdorff Distance (HD, voxel)/ Dice Similarity Score (DSC, %)/ Volume (V, mm3)/ Voxel (Vx, Number)/Time (t, min., sec.) Intervention 3: Manual maxillofacial bone segmentation by clinical experts (Ground Truth) on CT data basis: time of measurement (T) with Hausdorff Distance (HD, voxel)/ Dice Similarity Score (DSC, %)/ Volume (V, mm3)/ Voxel (Vx, Number)/ Time (t, min., sec.)
Primary Outcome(s)
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, %).
Secondary Outcome(s)
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.).
Secondary ID(s)
30-340 ex 17/18
Source(s) of Monetary Support
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)
FWF
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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