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

Completed

• Conditions: Orthognathic Surgery

• Registration Number: NCT03986710
• Lead Sponsor: AZ Sint-Jan AV

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2016-07-31
• Study Completion: 2017-02-28
• Study First Submitted: 2019-02-14
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-13
• Last Update Submitted: 2019-06-13
• Study First Posted: 2019-06-14
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
duration of 8 major steps in 3D virtual treatment planning	preoperative	duration of 8 major steps in 3D virtual treatment planning, measured in seconds with a digital online chronometer