Clinical Trials Directory

Trials / Completed

CompletedNCT03986710

Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: Single Surgeon Study

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
AZ Sint-Jan AV · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2016-04-01
Primary completion
2016-07-31
Completion
2017-02-28
First posted
2019-06-14
Last updated
2019-06-14

Source: ClinicalTrials.gov record NCT03986710. Inclusion in this directory is not an endorsement.