Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in masseter muscle electromyographic activity- sEMG examination
研究概览
简要总结
The aim of the project is to assess the effectiveness of reducing the masseter muscles tension and hyperactivity in patients with a painful form of TMD by using polymers containing CBD compared to placebo polymers.
详细描述
Since the healing properties of CBD have been known for a long time, the assumption of the proposed research is to reduce the tension of the masseter muscles, reduce the bruxism index and occlusal strength, as well as reduce pain, from which patients with TMD suffer.
CBD intraoral application therapy seems promising in that field. Patients attending The Department of TMD in Zabrze, Polska will be randomly divided into two groups: experimental and placebo. sEMG activity values will be compared during 14 and 30 days therapy with polymers. the efficacy of the cannabis cream used in the study. Positive results will confirm the efficacy of CBD relaxing properties used in the study, compared to placebo.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double masking
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient agreement to participate into the research study
- •Age ≥18 and ≤ 60
- •Good general health,
- •Temporomandibular disorder-positive RDC/TMD examination for group Ia and Ib
- •Presence of all teeth (with the exception of the third molars)
排除标准
- •Cannabis cream/ placebo cream allergy
- •Hypersensitivity to substances to be used in the study
- •Wounds intra oral cavity
- •Addiction to cannabis
- •Patients being treated with analgesic drugs and/or drugs that affect muscle function
结局指标
主要结局
Change in masseter muscle electromyographic activity- sEMG examination
时间窗: 30 days
Change in masseter muscle electromyographic activity-sEMG examination
Orofacial pain changes
时间窗: 30 days
Changes of felt pain recorded by means of VAS scale
次要结局
未报告次要终点