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

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.

Study Overview

• Status: Completed
• Conditions: Orthognathic Surgery

• Study Type: Observational
• Enrollment (Actual): 69

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who present themselves at the division of Maxillofacial surgery or Orthodontics, at the participating hospital centers for orthognathic surgery between May and August 2016

Description

Inclusion Criteria:

• Patients of all ages
• 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:

• All patients that do not fit the abovementioned description
• Patients with posttraumatic deformity
• Patients with congenital deformity
• Patients with pre-prosthetic indication

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
required time to complete total 3D virtual planning	required time to complete total 3D virtual planning, measured in seconds with a digital chronometer	preoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
required time to complete the 8 major virtual planning steps	required time to complete the 8 major virtual planning steps, measured in seconds with a digital chronometer	preoperative

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Collaborators: Radboud University Medical Center; IRCCS Azienda Ospedaliero-Universitaria di Bologna; University Hospital Heidelberg; Academisch Ziekenhuis Maastricht; Hospital of South West Jutland; University of Göttingen; AZ Monica Campus Antwerpen
• Investigators: Principal Investigator: Gwen Swennen, department of maxillofacial surgery, AZ Sint-Jan Brugge-Oostende AV

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): September 30, 2016
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: multicenter; timing; international; 3D virtual planning software; Individual Patient Solutions Case Designer (IPSCD)
• Other Study ID Numbers: 2004-MC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No