3D Printed Occlusal Splints for Intraoperative Use
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Time (hours) of delivery of models
研究概览
简要总结
A 3D printed intraoperative occlusal splint is a custom-made biocompatible resin guide that allows surgeons properly align a patient's upper and lower dentition during surgery. This alignment further places maxilla and mandible into proper position. An occlusal splint contains outlines maxillary and mandibular dentition allowing the teeth to lock into place with correct alignment.
At Johns Hopkins, traditionally hand-made and industry-made 3D printed splints have been used safely. However, prior studies have demonstrated the ability of in-house 3D prints to save time and money compared to industry. In-house models are similarly produced with FDA-clear, biocompatible resin for 3D printing, and maintain equivalent safety for patients compared to industry-made models.
详细描述
Treatment of dentofacial deformities requires restoration of occlusion. Occlusal splints stabilize the jaws intraoperatively to restore occlusion, which improve functions such as mastication, speech, breathing, and appearance.
Orthodontic resins and denture material have been used to fabricate dental splints due to the biocompatibility nature and ease of use. These materials, throughout the years, have been found to have structural stability, used for various purposes including nightguards, occlusal splints, etc. In recent years with the advanced of computer automated design (CAD/CAM), these splints have been outsourced to industry manufacturers.
Industry-made printed splints are costly and time-consuming, highlighting the need for faster, more affordable solutions. In-house printed splints have demonstrated consistent uniformity with negligible differences in shape to the source files. The investigators hypothesize that in-house printed models will be at least as effective as industry-made models in the application of acute craniofacial trauma while decreasing costs and production time.
This study evaluates the feasibility and benefits of in-house 3D printed occlusal splints. By using the same printers and biocompatible resin as industry manufacturers12, in-house splints maintain patient safety, while reducing hospital stay durations, lowering infection rates, and increasing hospital turnover. This approach could improve surgical efficiency and patient outcomes, offering a cost-effective alternative in mandibular surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any age who require any orthognathic surgery (including, but not limited to, facial fracture reduction and fixation, mandibular or maxillary reconstruction, cranial vault reconstruction, mandibular osteotomies, maxilla osteotomies) at Johns Hopkins Hospital.
排除标准
- •Patients who are non-English speaking.
- •Surgeons who do not perform orthognathic surgery with occlusal splints.
研究组 & 干预措施
Industry made splint
Occlusal splints will be 3D printed by industrial third party
干预措施: Industry made occlusal splint (Device)
In House made splint
In house 3D printed occlusal splint
干预措施: Formlabs 3D printed occlusal splint (Device)
结局指标
主要结局
Time (hours) of delivery of models
时间窗: Up to 1 year
Time of delivery of in-house and industry made splint models.
Cost of production for oral splint models
时间窗: Up to 1 year
Cost of production of in-house and industry-made models
Surgeon satisfaction assessed by survey
时间窗: Post surgery up to 1 month
Surgeon satisfaction between industry-made and in-house 3D printed occlusal splints. Score range between 5-20. Higher score more satisfaction.
次要结局
未报告次要终点