Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: Single Surgeon Study (IPSCD-TIM-GS)

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.

Study Overview

• Status: Completed
• Conditions: Orthognathic Surgery

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

consecutive orthognathic patients operated and planned by a single surgeon (GS)

Description

Inclusion Criteria:

• Patients of all ages
• Patients of both genders
• Patients should present themselves at the division of Maxillofacial 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 surgeon

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
duration of total 3D virtual treatment planning time	duration of total 3D virtual treatment planning time, measured in seconds with a digital online chronometer	preoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of 8 major steps in 3D virtual treatment planning	duration of 8 major steps in 3D virtual treatment planning, measured in seconds with a digital online chronometer	preoperative

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Gwen Swennen, AZ Sint-Jan Brugge-Oostende AV

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): July 31, 2016
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: timing; 3D virtual planning software
• Other Study ID Numbers: 2004

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