NCT04283981

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-01-24
• Primary completion: 2022-10-31
• Completion: 2022-11-10
• First posted: 2020-02-25
• Last updated: 2024-06-20
• Results posted: 2024-06-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study