CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Control group without use of VSP +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04283981
NCT04283981N/ACompleted
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Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures

The University of Texas Health Science Center, Houston·interventional·Posted Feb 25, 2020·Updated Jun 20, 2024

In Brief

A clinical study evaluating Control group without use of VSP and Treatment Group with use of VSP for Mandibular Fractures. Completed, enrolled 28 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMandibular Fractures
CountriesUnited States
CollaboratorsStryker Instruments

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 25, 2020
Enrollment StartJan 24, 2021
Primary CompletionOct 31, 2022
Study CompletionNov 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.4 years ago

Interventions

Control group without use of VSPdevice

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)

Treatment Group with use of VSPdevice

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