3D Printed Oral Stents for Patients Receiving Head and Neck Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- To evaluate whether a customized 3 dimensional (3D) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment.
研究概览
简要总结
This trial studies how a customized 3D-printed oral stent compares to a standard stent made by a dentist for use in imaging scans in patients with head and neck cancer receiving radiation therapy. Oral stents are designed to help prevent radiation-related side effects while receiving radiation therapy. Traditional oral stents are created by dentists, require at least 2 separate appointments, and may not be as cost-effective. A customized, 3D-printed oral stent may perform as well as a standard stent made by a dentist and have a significantly shorter turnaround to device delivery.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate whether a customized 3 dimensional (3D) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment.
SECONDARY OBJECTIVES:
I. To evaluate the performance of the 3D stent on imaging parameters (i.e. mandibular and soft tissue displacement) for degree of normal tissue sparing.
II. Evaluate the levels of patient reported outcomes after patients have developed side effects from radiation treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy.
- •Treating radiation oncologist has determined the necessity of an oral stent and a device has been fabricated by dentistry at MD Anderson Cancer Center (MDACC).
- •Patient has received pre-treatment imaging which includes the mandibular and maxillary dentition.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0-
- •Signed study-specific consent form.
排除标准
- •No pre-treatment computed tomography (CT) imaging including the maxilla and mandible is available.
- •Prior head and neck radiotherapy.
- •Severe trismus with an incisal opening of < 10 mm.
- •Inability to comply with the study procedures.
- •Patients who have received dental stents fabricated outside of MDACC.
结局指标
主要结局
To evaluate whether a customized 3 dimensional (3D) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment.
时间窗: up to 2 months
The patient will fill out a questionnaire that measures the form and fit of the 3D printed oral stent at specified time points, and this measurement will be compared with a standard stent. Score ranges(0-10) 0 None at all-10 As bad as you can imagine.
次要结局
未报告次要终点