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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.
Register: German Clinical Trials Register
Last refreshed on: 13 January 2020
Main ID:  DRKS00018928
Date of registration: 02/12/2019
Prospective Registration: No
Primary sponsor: LKH Universitätsklinikum Graz
Public title: Augmented Reality in Oral & Maxillofacial Surgery: The Evaluation and application of an 3D glass in the clinical Oral and Maxillofacial Surgery
Scientific title: Augmented Reality in Oral & Maxillofacial Surgery: The Evaluation and application of an 3D glass in the clinical Oral and Maxillofacial Surgery - enFacedAR
Date of first enrolment: 31/07/2019
Target sample size: 50
Recruitment status: Recruiting
URL:  http://www.drks.de/DRKS00018928
Study type:  observational
Study design:  Allocation: Other;. Masking: Open (masking not used). Control: Other. Assignment: Other. Study design purpose: Diagnostic;  
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: Jan    Egger
Address:  Auenbruggerplatz 5/1 8036 Graz Austria
Telephone: +43 316 873 5076
Email: jan.egger@medunigraz.at
Affiliation:  Medizinische Universität Graz
Key inclusion & exclusion criteria
Inclusion criteria: Dentulous and/or edentulous jaws, men and women (women also of childbearing age), age = 18, CT data acquired on the basis of medical diagnosis from the clinical routine in the Department of Oral and Maxillofacial Surgery at the Medical University of Graz, patients and CT data with a fracture of at least one bone in the cranio-maxillofacial complex, patients and PET/CT data from tumors in the head and neck/cranio-maxillofacial area.
Exclusion criteria: Existing Implants or osteosynthesis material, Age <18 Years, Lower jawbone necrosis or pathologic-cystic changes of the bones. Pregnant women.

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: Clinical evaluation of Augmented Reality in the facial/head area. Assessment/evaluation via two ISO questionnaire.
Primary Outcome(s)
ISO 9241/110 Questionnaire: Outcome is a score between 1 and 5, which will be acquired at the end of the experiments.
Secondary Outcome(s)
ISONORM 9241/10 Questionnaire: Outcome is a score between 1 and 5, which will be acquired at the end of the experiments.
Secondary ID(s)
31-416 ex 18/19
Source(s) of Monetary Support
FWF
Secondary Sponsor(s)
Ethics review
Status: approved
Approval date:
Contact:
Ethikkommission Med.Universität Graz
Auenbruggerplatz 2 A-8036 Graz Österreich
Results
Results available:
Date Posted:
Date Completed:
URL:
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