Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism by Different Injection Sites Evaluated by Polysomnography
试验速览
- 阶段
- 4 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The change of bruxism events
研究概览
简要总结
The purpose of this study is to evaluate the effect of Botulinum toxin type A(Meditoxin®) on bruxism using polysomnography and determine which site is most appropriate for injection to obtain maximal effects.
详细描述
Bruxism is an oral habit consisting of involuntary non-functional gnashing, clenching, grinding of teeth and is a very common condition in the general population. Various treatment modalities such as occlusal splints, pharmacologic agent and cognitive-behavioral therapy have been investigated for the management of bruxism, but none is reported to be fully effective. Recently locally injected botulinum toxin has been used in various movement disorders, but its usefulness and objective effects on nocturnal bruxism have not been evaluated using objective measures such as polysomnography. Moreover, there is no systematic study about which site is most appropriate for injection to obtain maximal effects.
The aim of this study is to evaluate the effect of botulinum toxin type A into masseter muscle or both masseter muscle and temporal muscle on nocturnal bruxism using polysomnography and the changes in the bruxism events on polysomnography.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of sleep bruxism confirmed by wear facets on occlusal splint
- •must be able to follow clinical trial procedure
- •who are suitable for this clinical trial
- •who participated in this clinical trial out of his own free will
排除标准
- •who take medications such as benzodiazepine or muscle relaxants
- •who have secondary bruxism due to brain injury
- •who are pregnant or have the possibility of pregnancy
- •who had an botulinum toxin injection during the past three months
- •who had an allergic reaction history to botulinum toxin
- •who have an infection or skin trouble on injection site
- •who have an other treatment plan for bruxism
- •who are enrolled in other clinical trials
- •who are not suitable for this clinical trials
- •who have mandibular dyskinesia or mandibular dystonia
研究组 & 干预措施
M group
A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm.
干预措施: Botulinum toxin type A (Meditoxin®) (Drug)
MT group
A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm.
干预措施: Botulinum toxin type A (Meditoxin®) (Drug)
结局指标
主要结局
The change of bruxism events
时间窗: At 4 weeks after Botulinum toxin type A injection
Before and after injection, we compared the change of bruxism event in polysomnography by sleep laboratory criteria. \<Sleep laboratory criteria\> - Mean SB EMG potential : \>10% or 20% of the maximal clench while awake (masseter muscles) In M group, Botulinum toxin was injected into masseter muscle. In TM group, Botulinum toxin was injected into masseter muscle and temporal muscle.
次要结局
- The change of masticatory force(%)(At 4 weeks after Botulinum toxin type A injection)
- The change of Pain(At 4 weeks after Botulinum toxin type A injection)
- Sleep-related breathing disorders(At 4 weeks after Botulinum toxin type A injection)
- Sleep-related movement disorders(At 4 weeks after Botulinum toxin type A injection)