Effects of Botulinum Toxin Type A (Xeomin®) Injections Into Bilateral Masseter Muscles for Management of Bruxism and Associated Symptoms: Single Center Open Label Longitudinal Pilot Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Verbal Rating Scale of Global impression of change
研究概览
简要总结
The purpose of this study is to test whether severe masticatory muscle spasms during sleep (e.g. teeth clenching and grinding, known as "bruxism" in technical jargon) demonstrably decrease after application of botulinum toxin type A (Xeomin®). Xeomin® has so far been used to relieve spasms of other muscles and is an approved drug in Switzerland. This study is now intended to test the suitability of this drug for relaxation of the masseter muscle.
详细描述
Bruxism is a prevalent condition that differentially burdens individuals. The overall objective of this pilot study is to measure the effects of BTX-A (Xeomin®) injections into bilateral masseter muscles for the management of sleep bruxism and associated symptoms. The hypothesis is that BTX-A reduces masticatory muscle activity. The aim of this study is to instrumentally monitor subjects closely over an extended time period of three months before and after application of BTX-A.
Botulinum toxin type A ( BTX A; Xeomin ® ) temporarily blocks neuromuscular synapses. It is successfully and safely used therapeutically in various types of movement disorders and in chronic migraineurs. The mechanism of action of this treatment is related to a reduction of neurotransmitter release leading to reduced muscle activity.
The following Null hypothesis will be tested:
Injections of Xeomin® into the masseter muscles bilaterally (25 Units per muscle applied with 2 injections in each muscle) have no effect on bruxism measured by A) Masticatory muscle activity (1° objective) B) Subjects' well-being (2° objective) C) Sensitivity of masticatory muscles and jaw joints (2° objective) D) Anxiety over tooth wear (2° objective) E) Disturbed sleep by bed partner (2° objective)
Following instruments will be used:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90 years;
- •patients complaining of bruxism and/or bruxism-related symptoms.
- •Sufficient knowledge of German to understand the patient information and the trial arrangement.
排除标准
- •Contraindications for Xeomin® treatment such as generalized disorders of muscle activity (myasthenia gravis, Lambert-Eaton-Rooke syndrome);
- •documented hypersensitivity to one of the components,
- •local infection of the injection sites;
- •intake of anticoagulants or muscle relaxing medications;
- •recreational drugs.
研究组 & 干预措施
Sleep Bruxism Subjects
Ultrasound guided BTX-A injection: 25 units (divided in two injections) in each masseter muscle.
One-time intervention. Effect observation by measuring various biosignals (EMG, EOG, EEG), bite force, chewing efficiency, psychometric assessments.
干预措施: Incobotulinumtoxin A (BTX A) Xeomin® (Drug)
结局指标
主要结局
Verbal Rating Scale of Global impression of change
时间窗: day 154
Verbal Rating Scale (VRS) containing the following levels "much worse", "slightly worse", "no change", "slightly improved", "much improved" of "global impression of change" at the end of the study (day 154)
Change of maximum EMG amplitudes
时间窗: days 1-14, days 29-42
Change of average of maximum EMG amplitudes of all bruxism events per night between days 1-14 (baseline) and days 29-42.
次要结局
- EMG amplitude at maximum voluntary contraction(days 1-14, days 15-28, days 85-98, days 141-154)
- Self-report of bruxism(day 1, 14, 28, 42, 98, 154)
- Change of maximum EMG amplitude(days 1-14, days 15-28, days 85-98, days 141-154)
- EMG-Index(days 1-14, days 15-28, days 85-98, days 141-154)
- EMG Duty Factor(days 1-14, days 15-28, days 85-98, days 141-154)
- number of masseter contraction episodes per hour (N/h)(days 1-14, days 15-28, days 85-98, days 141-154)
- duration of masseter contraction episodes (Dur)(days 1-14, days 15-28, days 85-98, days 141-154)
- Numerical Rating Scale masseter muscle pain(day 1, 14, 28, 42, 98, 154)
- Numerical Rating Scale report of anxiety over tooth wear(day 1, 14, 28, 42, 98, 154)
- Sensitivity of masticatory muscles and jaw joints(day 1, 14, 28, 42, 98, 154)
- Numerical Rating Scale report of spontaneous facial pain(day 1, 14, 28, 42, 98, 154)
- Numerical Rating Scale report of jaw movement related facial pain(day 1, 14, 28, 42, 98, 154)
- Numerical Rating Scale disturbed sleep of bed partner(day 1, 14, 28, 42, 98, 154)
研究者
Dominik Ettlin
Study Principal Investigator, MD, DMD
University of Zurich