Pilot Study on High Resolution 3D Digital Scanning for Maxillofacial Prosthetics for Feasibility and Efficacy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prosthetic Treatment
- Sponsor
- University of Michigan
- Locations
- 1
- Primary Endpoint
- Number or weeks to create the final prosthesis
- Status
- Withdrawn
- Last Updated
- last year
Overview
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 preserves the quality of the current method while reducing time spent by both the patient and providers. Patients that are eligible will have a non-invasive 3D scanner (Artec Space Spider) to image the indicated areas of their head and face to help create their new prosthesis. Patients will come in for visits as needed to fit and adjust their prosthetic. Additionally, patients will be asked to complete questionnaires and have follow-up visits at certain time -points pre and post prosthetic completion.
Investigators
David Zopf
Assistant Professor of Otorhinolaryngology
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •Known allergy to silicone
- •Poor candidate for prosthetic reconstruction
- •Developmental concerns regarding aspiration risk
Outcomes
Primary Outcomes
Number or weeks to create the final prosthesis
Time Frame: up to 6 months
Number of hours spent to create the prosthetic
Time Frame: up to 6 months
The number of hours will be calculated by using the design software, scanners, printing, and modifying the mold and prosthesis.
Time the participants spend in the clinic
Time Frame: up to 6 months
This includes time spent with participant to design the prosthetic
Secondary Outcomes
- Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for extraoral prosthesis.(up to 6 months after the prosthetic is completed and being used)
- Quality of life measures by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for intraoral prosthesis.(up to 6 months after the prosthetic is completed and being used)
- Quality of life measures by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for extraoral prosthesis.(up to 6 months after the prosthetic is completed and being used)
- Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for intraoral prosthesis.(up to 6 months after the prosthetic is completed and being used)
- Number of adverse events related to the prosthetic(up to 6 months after the prosthetic is completed and being used)