Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: Single Surgeon Study (IPSCD-TIM-GS)
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|ClinicalTrials.gov Identifier: NCT03986710|
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are becoming state of the art in orthognathic surgery. However, current available software is still too time-consuming. KLS Martin (Tuttlingen, Germany) has currently completed the preclinical phase of their novel 3D virtual planning software, "IPS (Individual Patient Solutions) CaseDesigner (IPSCD)".
Objectives The authors aim to test pre-release versions of the IPSCD software under real-world working conditions by a single surgeon.In specific, the authors aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time.
Study design closed beta-phase 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 will run all the virtual planning steps with both conventional software (Maxilim) and the novel software. Timing of the eight major steps will be measured with a digital chronometer.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||July 31, 2016|
|Actual Study Completion Date :||February 28, 2017|
- duration of total 3D virtual treatment planning time [ Time Frame: preoperative ]duration of total 3D virtual treatment planning time, measured in seconds with a digital online chronometer
- duration of 8 major steps in 3D virtual treatment planning [ Time Frame: preoperative ]duration of 8 major steps in 3D virtual treatment planning, measured in seconds with a digital online chronometer
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986710
|Principal Investigator:||Gwen Swennen||AZ Sint-Jan Brugge-Oostende AV|