Digital Design for Maxillofacial Prosthetics

Pilot Study on High Resolution 3D Digital Scanning for Maxillofacial Prosthetics for Feasibility and Efficacy

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.

Study Overview

• Status: Recruiting
• Conditions: Maxillofacial Abnormalities; Craniofacial Abnormalities; Prosthetic Treatment
• Intervention / Treatment: Device: 3D digital scanning for maxillofacial prosthetics

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Zopf, MD; Phone Number: 7349364585; Email: davidzop@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48170
      • Recruiting
      • University of Michigan
      • Contact: David Zopf, MD; Phone Number: 734-936-4585; Email: davidzop@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 3D digital scanning for maxillofacial prosthetics

Device: 3D digital scanning for maxillofacial prosthetics; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for intraoral prosthesis.	Survey questions are all created using a 7-point Likert scale for assessment. Questions 10-17 from the survey will be used to measure the patients prosthesis level of satisfaction (the higher the score the more satisfied). These will be completed pre-prosthesis and at 1 month and 6 months post prosthesis for patients with 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.	Survey questions are all created using a 7-point Likert scale for assessment. Questions 8-19 from the survey will be used to measure the patients level of satisfaction (the higher the score the more satisfied). These will be completed pre-prosthesis and at 1 month and 6 months post prosthesis for patients with 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.	Survey questions are all created using a 7-point Likert scale for assessment. Questions 1-9 from the survey will be used to measure the patients level of quality of life (the higher score indicates better quality). These will be completed pre-prosthesis and at 1 month and 6 months post prosthesis for patients with 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.	Survey questions are all created using a 7-point Likert scale for assessment. Questions 1-7 from the survey will be used to measure the patients quality of life (the higher score indicates be better quality). These will be completed pre-prosthesis and at 1 month and 6 months post prosthesis for patients with extraoral prosthesis.	up to 6 months after the prosthetic is completed and being used
Number of adverse events related to the prosthetic	This study will collect and report adverse events (serious and non-serious) at least possibly related to the prosthetic.	up to 6 months after the prosthetic is completed and being used

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: David Zopf, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: prosthetic treatment; rhinectomy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Craniofacial Abnormalities; Maxillofacial Abnormalities
• Other Study ID Numbers: HUM00155762

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No