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NCT03986723 Clinical Trial

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

Orthognathic Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03986723
Other study ID # 2241
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 29, 2017
Est. completion date March 31, 2018

Study information
Verified date January 2021
Source AZ Sint-Jan AV
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium AZ Sint-Jan Brugge-Oostende AV Brugge

Sponsors (1)
Lead Sponsor Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary time efficiency: duration of the complete workflow, measured in seconds with a digital chronometer duration of the complete workflow, measured in seconds with a digital chronometer preoperative
Secondary reliability of the workflow through registration of problems, difficulties that occur evaluation of the reliability of the workflow through registration of problems, difficulties that occur preoperative
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