Digital Design for Maxillofacial Prosthetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2023-07-31

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.

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Detailed Description

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Conditions

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Prosthetic Treatment Craniofacial Abnormalities Maxillofacial Abnormalities

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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3D digital scanning for maxillofacial prosthetics

Group Type EXPERIMENTAL

3D digital scanning for maxillofacial prosthetics

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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