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Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures

NCT04283981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-06-20

Study results available
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Summary

The purpose of this trial is to compare operating room time between conventional treatment techniques \[without Virtual surgical Planning (VSP)\] versus treatment with use of Virtual surgical Planning (VSP) in patients that undergo mandibular reconstruction via open reduction internal fixation (ORIF).

Conditions

  • Mandibular Fractures

Interventions

DEVICE

Control group without use of VSP

The control group will include patients that undergo mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) in standard fashion (without virtual surgical planning assistance and occlusal splint)

DEVICE

Treatment Group with use of VSP

The treatment group corresponds to patients undergoing mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) utilizing virtual surgical planning via 3D Systems, bite registration and fabrication of occlusal splint via intraoral digital scanner, and mandibular hardware

Sponsors & Collaborators

  • Stryker Instruments

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Timothy Woernley, DDS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-24
Primary Completion
2022-10-31
Completion
2022-11-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283981 on ClinicalTrials.gov