Efficacy of 3D-Printed Mouth Splints in the Management of Microstomia in Burn Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Oral Aperture measurements
研究概览
简要总结
The study will investigate the effectiveness of a 3D-printed mouth splint designed to increase dimensions of oral aperture and reduce disability associated with mouth contractures. The validated Mouth Impairment and Disability Assessment (MIDA) survey will be used to objectively measure patient progress in functionality and quality of life.
详细描述
Microstomia, or reduced oral aperture, is a debilitating condition that can arise after burn injuries, particularly to the face. This condition severely impacts oral hygiene, nutrition, speech, and overall quality of life. Current management strategies often rely on therapy, surgical intervention, and splinting to improve mouth opening and functionality. However, there is a lack of accessibility to good mouth splinting devices. 3D-printed, dynamic splints offer may offer a superior and cost-effective solution that can be tailored to the patient's anatomy while allowing for at-home treatment. Sizing can also be adjusted to fit essentially any aperture since, including pediatrics. This device is intended for use at home, supported by teaching and follow-up provided by occupational therapists (OTs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 2 years to 99 years of age with documented microstomia following burn injuries.
- •Ability to comply with prescribed home exercises and follow-up visits.
排除标准
- •Cognitive or physical inability to perform the prescribed exercises.
- •Inability of a caretaker to be able to deliver therapy daily.
- •Concomitant conditions that may significantly affect oral aperture (e.g., temporomandibular joint (TMJ) disorders).
结局指标
主要结局
Change in Oral Aperture measurements
时间窗: Baseline to Month 3
Difference in measurements of oral aperture from Baseline visit to Final visit will be reported - Oral aperture measurements taken with calipers
次要结局
- Change in Mouth Impairment and Disability Assessment (MIDA) Scores(Baseline to Month 3)
- Change in Patient Satisfaction Scores(Baseline to Month 3)