Augmented Reality in Oral & Maxillofacial Surgery: The Evaluation and application of an 3D glass in the clinical Oral and Maxillofacial Surgery
Organizational Data
- DRKS-ID:
- DRKS00018928
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2019-12-02
- Last update in DRKS:
- 2019-12-02
- Registration type:
- Retrospective
Acronym/abbreviation of the study
enFacedAR
URL of the study
No Entry
Brief summary in lay language
In this project, CT images of patients with mandibular or mid-face fractures, or PET/CT images from patients with head-neck tumors, will be displayed in an augmented reality environment (e.g. using the 3D glasses Microsoft Hololens®). The 3D visualization of the CT or PET/CT images will be examined by clinical experts (physicians) directly on and in relation to the patient. Medical image data will be acquired from the clinical routine, specifically from patients who underwent a CT or PET/CT scan because of a medical indication. Afterwards, the application and the possible benefit of this technology for the clinical domain will be evaluated with several clinical experts and questionnaires. Hence, the aim of this observational study is a clinical evaluation of augmented reality (e.g. with a 3D glass) in the area of cranio-maxillofacial surgery. The evaluation will be based on clinical CT and PET/CT data.
Brief summary in scientific language
In this project, CT images of patients with mandibular or mid-face fractures, or PET/CT images from patients with head-neck tumors, will be displayed in an augmented reality environment (e.g. using the 3D glasses Microsoft Hololens®). The 3D visualization of the CT or PET/CT images will be examined by clinical experts (physicians) directly on and in relation to the patient. Medical image data will be acquired from the clinical routine, specifically from patients who underwent a CT or PET/CT scan because of a medical indication. Afterwards, the application and the possible benefit of this technology for the clinical domain will be evaluated with several clinical experts and questionnaires. Hence, the aim of this observational study is a clinical evaluation of augmented reality (e.g. with a 3D glass) in the area of cranio-maxillofacial surgery. The evaluation will be based on clinical CT and PET/CT data.
Health condition or problem studied
- ICD10:
- S02 - Fracture of skull and facial bones
- ICD10:
- M85 - Other disorders of bone density and structure
- ICD10:
- Q75 - Other congenital malformations of skull and face bones
- ICD10:
- S09 - Other and unspecified injuries of head
- ICD10:
- K10 - Other diseases of jaws
- ICD10:
- K07 - Dentofacial anomalies [including malocclusion]
- ICD10:
- Z96 - Presence of other functional implants
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Clinical evaluation of Augmented Reality in the facial/head area. Assessment/evaluation via two ISO questionnaire.
Endpoints
- Primary outcome:
- ISO 9241/110 Questionnaire: Outcome is a score between 1 and 5, which will be acquired at the end of the experiments.
- Secondary outcome:
- ISONORM 9241/10 Questionnaire: Outcome is a score between 1 and 5, which will be acquired at the end of the experiments.
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Medizinische Universität Graz, Graz
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2019-07-31
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 50
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 99 Years
- Additional 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.
Addresses
Primary Sponsor
- Address:
- LKH Universitätsklinikum GrazAuenbrugger Platz 18036 GrazAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.lkh-graz.at
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Medizinische Universität GrazPriv.-Doz. Dr. Dr. Jan EggerAuenbruggerplatz 5/18036 GrazAustria
- Telephone:
- +43 316 873 5076
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medunigraz.at/en/
Contact for Public Queries
- Address:
- Medizinische Universität GrazDDDr. Jürgen WallnerAuenbruggerplatz 5/18036 GrazAustria
- Telephone:
- +43/316/385-12428
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medunigraz.at/en/
Principal Investigator
- Address:
- Medizinische Universität GrazPriv.-Doz. Dr. Dr. Jan EggerAuenbruggerplatz 5/18036 GrazAustria
- Telephone:
- +43 316 873 5076
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medunigraz.at/en/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- FWFSensengasse 11090 WienAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Universität GrazAuenbruggerplatz 28036 GrazGermany
- Telephone:
- (+43)316-38513928
- Fax:
- (+43)316-38514348
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-05-14
- Ethics committee number:
- 31-416 ex 18/19
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-06-26
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- We will provide PET-CT datasets
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry