An interventional study of 3D digital scanning for maxillofacial prosthetics in Prosthetic Treatment, Craniofacial Abnormalities and Maxillofacial Abnormalities, sponsored by University of Michigan. Withdrawn at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by University of Michigan · Not applicable, Interventional, and Other
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.
Exclusion Criteria:
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.
Number or weeks to create the final prosthesis
Time frame: up to 6 months
Time the participants spend in the clinic
This includes time spent with participant to design the prosthetic
Time frame: 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.
Time frame: up to 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 6 months after the prosthetic is completed and being used
This study is withdrawn, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Michigan