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

Orthognathic Surgery Clinical Trial

— 3D IPSCD-TIM  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843138
• Other study ID #: 2004-MC
• Status: Completed
• Start date: May 2016
• Est. completion date: March 31, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 31, 2017
• Est. primary completion date: September 30, 2016
• 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 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

Related Conditions & MeSH terms

• Orthognathic Surgery

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
AZ Sint-Jan AV	Academisch Ziekenhuis Maastricht, AZ Monica Campus Antwerpen, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi, Radboud University, Sydvestjysk Hospital, University Hospital Heidelberg, University of Göttingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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