The Effect on Envelope of Motion in Asymptomatic Bruxers - A Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of envelope of motion
研究概览
简要总结
Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.
详细描述
Research subjects will be allocated to placebo or botulinum neurotoxin intervention. A control group will not receive any intervention. The intervention will be administered at three separate sessions with 12 weeks in between. Prior to intervention, and 6 months after last intervention the jaw-neck envelope of motion will be studied using 3D optoelectronic recording systems.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Computerised randomisation, colour coded intervention.
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Tooth wear into dentin.
排除标准
- •No temporomandibular pathology.
- •No drugs affecting the central nervous system.
- •No conditions affecting muscles or central nervous system.
研究组 & 干预措施
BoNT A (botulinum neurotoxin type A)
Botulinum neurotoxin, 25 units (U) into each masseter at three sessions.
干预措施: Botulinum toxin type A (Drug)
Placebo
Saline solution
干预措施: Placebo (Drug)
Control
Saline solution, no tooth wear
干预措施: Placebo (Drug)
结局指标
主要结局
Change of envelope of motion
时间窗: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Volume of envelope of motion measured in cubic millimeters.
Change of range of motion
时间窗: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Measured on a cartesian plane in millimeters.
Change of length in chewing cycles
时间窗: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Repetitive chewing cycles, measured in milliseconds.
次要结局
- Tooth wear, change of hard tissue mass(Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.)
- Change of muscle thickness(Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.)
- Change of maximal voluntary bite force(Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.)