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Completed

NCT Number: NCT03986710

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

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.

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Key information

Conditions

Orthognathic Surgery

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. duration of 8 major steps in 3D virtual treatment planning

    Time frame: preoperative

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

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Acronym: IPSCD-TIM-GS

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jun 14, 2019
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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