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Digital Design for Maxillofacial Prosthetics

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University of Michigan

Status

Withdrawn

Conditions

Maxillofacial Abnormalities
Prosthetic Treatment
Craniofacial Abnormalities

Treatments

Device: 3D digital scanning for maxillofacial prosthetics

Study type

Interventional

Funder types

Other

Identifiers

NCT04035928
HUM00155762

Details and patient eligibility

About

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.

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

3D digital scanning for maxillofacial prosthetics
Experimental group
Treatment:
Device: 3D digital scanning for maxillofacial prosthetics

Trial contacts and locations

1

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Central trial contact

David Zopf, MD

Data sourced from clinicaltrials.gov

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