Digital Design for Maxillofacial Prosthetics

Study Overview
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Brief Summary
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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.

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

Conditions
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Prosthetic Treatment, Craniofacial Abnormalities, Maxillofacial Abnormalities

Intervention / Treatment
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* Device: 3D digital scanning for maxillofacial prosthetics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D digital scanning for maxillofacial prosthetics<br> | Device: 3D digital scanning for maxillofacial prosthetics<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prosthetic treatment, rhinectomy