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

Orthognathic Surgery Clinical Trial

— IPSCD-TIM-GS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986710
• Other study ID #: 2004
• Status: Completed
• Start date: April 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: June 2019
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2017
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Orthognathic Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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