Skip to main content
Clinical Trials/NCT03986710
NCT03986710
Completed
Not Applicable

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

AZ Sint-Jan AV0 sites20 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthognathic Surgery
Sponsor
AZ Sint-Jan AV
Enrollment
20
Primary Endpoint
duration of total 3D virtual treatment planning time
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
February 28, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gwen Swennen

maxillofacial surgeon, principal investigator

AZ Sint-Jan AV

Eligibility Criteria

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

Outcomes

Primary Outcomes

duration of total 3D virtual treatment planning time

Time Frame: preoperative

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

Secondary Outcomes

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

Similar Trials