Dynasplint Therapy for Trismus in Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors
研究概览
简要总结
The purpose of this study is to compare the use of the Dynasplint Trismus System to routine trismus treatment in improving the ability of opening the mouth in a randomized trial. This study will also determine what effects, good and/or bad, this procedure has on the participant. Participants will be randomly assigned to the Dynasplint Trismus System or to routine treatment with tongue depressors.
详细描述
This trial is a single-institution, randomized study to evaluate the effectiveness of the Dynasplint Trismus System (DTS) for patients with trismus. Improvement of mouth opening and quality of life of participants using DTS will be compared to improvement of mouth opening and quality of life of participants using standard therapy. Standard therapy will be the use of tongue depressors. Crossover from standard therapy to DTS will be implemented if at three months there is no improvement in mouth opening when using tongue depressors.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with <= 30mm mouth opening who have undergone treatment for head and neck cancer. (If the patient is edentulous then mouth opening must be <= 40mm.)
- •Patients who are receiving or have completed treatment for head and neck cancer (surgery, radiation, chemotherapy alone or in any combination).
- •Patients must be completely recovered from any radiation induced oral mucositis.
- •Age =>19 years.
- •Patients must sign informed consent.
排除标准
- •Severe periodontal or gum disease that has caused teeth to be loose.
- •Any systemic disease that causes blistering of the oral mucosa.
- •Any condition that renders the patient unable to understand the informed consent.
- •Participants who are not able to comply with protocol activities.
结局指标
主要结局
Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors
时间窗: 12 months
Number of participants who demonstrated improved maximal incisial opening (MIO), the distance from the tips of the upper and lower incisors on maximal effort. Successful improvement is defined as \> 5mm improvement from the baseline measurement.
次要结局
未报告次要终点
研究者
William Carroll, MD
Professor of Otolaryngology
University of Alabama at Birmingham