Digital Design for Maxillofacial Prosthetics

Maxillofacial Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04035928
• Other study ID #: HUM00155762
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: July 2023

Study information

• Verified date: May 2022
• Source: University of Michigan
• Contact: David Zopf, MD
• Phone: 7349364585
• Email: davidzop[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Craniofacial Abnormalities
• Maxillofacial Abnormalities
• Prosthetic Treatment

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number or weeks to create the final prosthesis		up to 6 months
Primary	Time the participants spend in the clinic	This includes time spent with participant to design the prosthetic	up to 6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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