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

NCT03986710 | Completed

• 1 other identifier: 2004
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orthognathic Surgery

Keywords

3D virtual planning software; timing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• duration of 8 major steps in 3D virtual treatment planning

  preoperative

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Officials

• Gwen Swennen

  AZ Sint-Lucas Brugge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: maxillofacial surgeon, principal investigator

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: June 14, 2019
• Study Start: April 1, 2016
• Primary Completion: July 31, 2016
• Study Completion: February 28, 2017
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share