Status:
WITHDRAWN
Digital Design for Maxillofacial Prosthetics
Lead Sponsor:
University of Michigan
Conditions:
Prosthetic Treatment
Craniofacial Abnormalities
Eligibility:
All Genders
6+ years
Phase:
NA
Brief Summary
This study will use a 3D scanner to print a 3D model or mold for each patient's prosthesis. The goal of this study to provide patients with a new, faster method of imaging and creating prostheses that...
Eligibility Criteria
Inclusion
- Maxillofacial anatomic defect or anomaly that limits function or cosmesis (including facial and/or intraoral)
- Stable defect (no clinically active tumor or plans for major reconstructive surgery)
- The patient (or family) have elected to pursue a prosthetic reconstruction of a craniofacial anomaly
- The patient is amenable to 3D surface scanning rather than facial molding
Exclusion
- Known allergy to silicone
- Poor candidate for prosthetic reconstruction
- Developmental concerns regarding aspiration risk
Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04035928
Start Date
October 14 2019
End Date
July 1 2023
Last Update
June 24 2024
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48170