Digital Design for Maxillofacial Prosthetics

NCT04035928 | Withdrawn

• 1 other identifier: HUM00155762
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthetic Treatment; Craniofacial Abnormalities; Maxillofacial Abnormalities

Keywords

prosthetic treatment; rhinectomy

Outcome Measures

Primary Outcomes (3)

• Number or weeks to create the final prosthesis

  up to 6 months

• Time the participants spend in the clinic

  This includes time spent with participant to design the prosthetic

  up to 6 months

• Number of hours spent to create the prosthetic

  The number of hours will be calculated by using the design software, scanners, printing, and modifying the mold and prosthesis.

  up to 6 months

Secondary Outcomes (5)

• 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

• 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

• Number of adverse events related to the prosthetic

  up to 6 months after the prosthetic is completed and being used

Study Arms (1)

3D digital scanning for maxillofacial prosthetics

EXPERIMENTAL

Device: 3D digital scanning for maxillofacial prosthetics

Interventions

3D digital scanning for maxillofacial prosthetics DEVICE

The non-invasive Artec Space Spider 3D scanner will be used to image the indicated areas of the patients head and face. In the case of an intraoral defect, the noninvasive TRIOS intraoral 3D scanner will be used. The study may also use nasometry or nasal endoscopy to measure the amount of airflow through the patient's fistula to help guide the design. The software that will be used will create a 3D image of the prosthesis during the patient's clinic appointment. Once a model of the prosthesis is fully designed and manufactured, the patient will return to clinic for a second appointment which may involve fitting and coloring. A subsequent appointment will involve delivery of a successfully fitted and colored prosthesis that the patient will take home.

3D digital scanning for maxillofacial prosthetics

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to silicone
• Poor candidate for prosthetic reconstruction
• Developmental concerns regarding aspiration risk

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48170, United States

Location

MeSH Terms

Conditions

Craniofacial Abnormalities; Maxillofacial Abnormalities

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases

Study Officials

• David Zopf, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otorhinolaryngology

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 29, 2019
• Study Start: October 14, 2019
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

US (1)