Clinical trial NCT04035928: Digital Design for Maxillofacial Prosthetics
Official title: Pilot Study on High Resolution 3D Digital Scanning for Maxillofacial Prosthetics for Feasibility and Efficacy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prosthetic Treatment
Craniofacial Abnormalities
Maxillofacial Abnormalities
Keywords: prosthetic treatment
rhinectomy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Number or weeks to create the final prosthesis
timeFrame: up to 6 months
measure: Time the participants spend in the clinic
timeFrame: up to 6 months
measure: Number of hours spent to create the prosthetic
timeFrame: up to 6 months
Secondary outcomes:
measure: Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for intraoral prosthesis.
timeFrame: up to 6 months after the prosthetic is completed and being used
measure: Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for extraoral prosthesis.
timeFrame: up to 6 months after the prosthetic is completed and being used
measure: Quality of life measures by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for intraoral prosthesis.
timeFrame: up to 6 months after the prosthetic is completed and being used
measure: Quality of life measures by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for extraoral prosthesis.
timeFrame: up to 6 months after the prosthetic is completed and being used
measure: Number of adverse events related to the prosthetic
timeFrame: up to 6 months after the prosthetic is completed and being used
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: David Zopf, MD
role: PRINCIPAL_INVESTIGATOR
References: