MedTrace Logo

Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: an International, Multi-centric, Prospective Study

NCT03843138 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 69

Last updated 2019-06-17

No results posted yet for this study

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 and the single surgeon (GS) closed beta-phase of their novel 3D virtual planning software, IPS (Individual Patient Solutions) CaseDesigner (IPSCD).

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.

Conditions

  • Orthognathic Surgery

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER

  • University of Göttingen

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • University Hospital Heidelberg

    collaborator OTHER

  • AZ Monica Campus Antwerpen

    collaborator UNKNOWN

  • Academisch Ziekenhuis Maastricht

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

  • Gwen Swennen · department of maxillofacial surgery, AZ Sint-Jan Brugge-Oostende AV

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-09-30
Completion
2017-03-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843138 on ClinicalTrials.gov