Digital Design for Maxillofacial Prosthetics

Not Applicable

Withdrawn

• Conditions: Craniofacial Abnormalities; Prosthetic Treatment; Maxillofacial Abnormalities
• Interventions: Device: 3D digital scanning for maxillofacial prosthetics

• Registration Number: NCT04035928
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-29
• Study Start: 2019-10-14
• Primary Completion: 2023-07
• Study Completion: 2023-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D digital scanning for maxillofacial prosthetics	3D digital scanning for maxillofacial prosthetics	-

Primary Outcome Measures

Name	Time	Method
Number or weeks to create the final prosthesis	up to 6 months
Number of hours spent to create the prosthetic	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	up to 6 months	This includes time spent with participant to design the prosthetic

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
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	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.
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	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.
Number of adverse events related to the prosthetic	up to 6 months after the prosthetic is completed and being used	This study will collect and report adverse events (serious and non-serious) at least possibly related to the prosthetic.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States