Use of Botox Versus Conventional Treatment for Pain Decrease of Muscular Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Masticatory muscle pain
研究概览
简要总结
This randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. Fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. For the splint group, a rigid splint will be worn by the patient every night. For the botox group, 60u of botox will be injected in 3 regions of the masseter muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning of the study. Oral health related quality of life, pain, and cervical neck position will be evaluated. Paired t-test and chi-square will be used for statistical analysis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 70 years old;
- •at least 20 teeth in the mouth;
- •occlusal stability;
- •presenting pain in face muscles.
排除标准
- •Angle's Class III
- •Kennedy's Class II or I removable partial denture wearer;
- •Complete denture wearer;
- •Individuals that have taken any anti inflammatory drugs in the last 3 months;
- •Individuals with temporomandibular joint disorders.
研究组 & 干预措施
Botox
In this group patients will receive 3 injections of botox on each masseter (left and right), after randomization. This injection will be performed once, and the patient will be evaluated after 3 and 6 months after this day.
干预措施: Botox Injectable Product (Drug)
Occlusal splint
In this group patients will receive an occlusal splint, which will be manufactured after taking their full mouth impression. This appliance has to be worn everyday, for 6 months, at night.
干预措施: Occlusal splint (Device)
结局指标
主要结局
Masticatory muscle pain
时间窗: baseline, 3 and 6 months
VAS will be used to assess decrease of pain
次要结局
- Oral health related quality of life(baseline, 3 and 6 months)
- Cervical Position(baseline, 3 and 6 months)
研究者
Maximiliano Sergio Cenci
PhD
Federal University of Pelotas