Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: an International, Multi-centric, Prospective Study
NCT ID: NCT03843138
Last Updated: 2019-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
69 participants
OBSERVATIONAL
2016-05-31
2017-03-31
Brief Summary
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Objectives The investigators aim to test pre-release versions of the IPSCD software under real-world working conditions in strictly selected university, general and private hospital settings. In specific, they aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time.
Study design closed beta-phase; international, multi-centric, prospective study Patients presenting at the division of maxillofacial surgery at the different hospital centers, for an orthognathic-related problem will receive a complete routine work-up, including a cone-beam CT (CBCT) according to the IPSCD protocol. The same surgeon and/or orthodontist will run all the virtual planning steps with the novel software. Timing of the eight major steps will be measured with a digital chronometer.
One hundred and eight patient cases will be planned with the IPSCD software in the participating centers over a period of three months, in the order of respectively one, three and five cases per month per participating center.
Investigators will register anonymized patient demographics (age, gender, clinical diagnosis, type of surgery), and provide feedback regarding the required time to complete the different surgical planning steps, regarding the number of failed alignments, and the occurrence of software bugs. Intergroup comparison of virtual planning time between the different centers will be analyzed. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon and/or orthodontist, or in comparison to the initial beta-testing phase results by GS.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients of both genders
* Patients should present themselves at the division of Maxillofacial surgery or Orthodontics, at the participating hospital centers for orthognathic surgery
* Patients should receive standardized cone-beam computed tomography (CBCT) image acquisition, according to the IPSCD protocol
* Preoperative 3D virtual planning should be performed by the same investigator per center with the IPSCD software
Exclusion Criteria
* Patients with posttraumatic deformity
* Patients with congenital deformity
* Patients with pre-prosthetic indication
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
University of Göttingen
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
University Hospital Heidelberg
OTHER
AZ Monica Campus Antwerpen
UNKNOWN
Academisch Ziekenhuis Maastricht
OTHER
Radboud University Medical Center
OTHER
AZ Sint-Jan AV
OTHER
Responsible Party
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Gwen Swennen
maxillofacial surgeon, principal investigator
Principal Investigators
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Gwen Swennen
Role: PRINCIPAL_INVESTIGATOR
department of maxillofacial surgery, AZ Sint-Jan Brugge-Oostende AV
Other Identifiers
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2004-MC
Identifier Type: -
Identifier Source: org_study_id
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