Methodology for Developing an Occlusal Appliance With CBD Active Carrier
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of sEMG activity of masseter muscle
研究概览
简要总结
Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients
详细描述
Occlusal appliance therapies are used in TMD patients. In this research the active CBD molecules will be released from the occlusal appliance during nighttime, in population of patients suffering from TMD. The effectiveness of the myorelaxation (sEMG of mastcatory muscles activity) and analgesic effect( VAS analysis) of occlusal appliance with the CBD molecules will be compared to the traditional acrylic-resin material used so far for occlusal appliance manufacture. The aim of the research is the evaluation of the innovative material effectiveness, used for the production of the occlusal appliance.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient agreement to take part in the study
- •RDC/TMD group Ia and Ib
- •Bruxism Index> 3 ( Brux-off polysomnography)
排除标准
- •CBD allergy/hypersensitivity/ addiction
- •Therapy with analgesic drugs
- •Therapy with drugs affecting muscle function
- •Fixed or removable dental prosthesis
- •Ongoing orthodontic treatment
- •Other general disorders affecting muscle tension
研究组 & 干预措施
CBD occlusal appliance
CBD occlusal appliance
干预措施: CBD occlusal appliance (Drug)
occlusal appliance
Traditional material occlusal appliance
干预措施: Acrylic resin occlusal appliance (Device)
结局指标
主要结局
Reduction of sEMG activity of masseter muscle
时间窗: 40 days
Reduction of sEMG activity of masseter muscle
次要结局
- Reduction of pain intensity in VAS(40 days)
研究者
Aleksandra Nitecka-Buchta
dr n. med.
Medical University of Silesia