Pilot Study on High Resolution 3D Digital Scanning for Maxillofacial Prosthetics for Feasibility and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number or weeks to create the final prosthesis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Known allergy to silicone
- •Poor candidate for prosthetic reconstruction
- •Developmental concerns regarding aspiration risk
研究组 & 干预措施
3D digital scanning for maxillofacial prosthetics
干预措施: 3D digital scanning for maxillofacial prosthetics (Device)
结局指标
主要结局
Number or weeks to create the final prosthesis
时间窗: up to 6 months
Number of hours spent to create the prosthetic
时间窗: up to 6 months
The number of hours will be calculated by using the design software, scanners, printing, and modifying the mold and prosthesis.
Time the participants spend in the clinic
时间窗: up to 6 months
This includes time spent with participant to design the prosthetic
次要结局
- Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for 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.(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.(up to 6 months after the prosthetic is completed and being used)
- Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for intraoral prosthesis.(up to 6 months after the prosthetic is completed and being used)
- Number of adverse events related to the prosthetic(up to 6 months after the prosthetic is completed and being used)
研究者
David Zopf
Assistant Professor of Otorhinolaryngology
University of Michigan