Maxillofacial Abnormalities Clinical Trial
Official title:
Pilot Study on High Resolution 3D Digital Scanning for Maxillofacial Prosthetics for Feasibility and Efficacy
NCT number | NCT04035928 |
Other study ID # | HUM00155762 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 14, 2019 |
Est. completion date | July 2023 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
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 |
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