3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery

January 15, 2021 updated by: Gwen Swennen, AZ Sint-Jan AV

Evaluation of Implementation of 3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery

Despite the shift from 2D towards 3D virtual treatment planning of orthognathic surgery, traditional plaster cast are still gold standard. The investigators aimed to compare the overall reliability and time efficiency of an digital workflow using 3D printed models, in comparison to the conventional plaster workflow.

Twenty real-life cases were planned according to both workflows and timed by a single resident.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
        • AZ Sint-Jan Brugge-Oostende AV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

consecutive orthognathic cases planned with 3D virtual planning software

Description

Inclusion Criteria:

  • planned for orthognathic surgery
  • planning by a single resident
  • planning based on 3D virtual workflow

Exclusion Criteria:

  • not eligible according to abovementioned criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time efficiency: duration of the complete workflow, measured in seconds with a digital chronometer
Time Frame: preoperative
duration of the complete workflow, measured in seconds with a digital chronometer
preoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reliability of the workflow through registration of problems, difficulties that occur
Time Frame: preoperative
evaluation of the reliability of the workflow through registration of problems, difficulties that occur
preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Sint-Jan AV

Investigators

  • Principal Investigator: Gwen Swennen, MD PhD, AZ Sint-Jan Brugge-Oostende AV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Orthognathic Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe