Muscle Weakness Duration Post-injection of a Single Dose of Botulinum Toxin in the Masseter Muscle Bilaterally: a One-year Non-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change of bite force
研究概览
简要总结
This study aimed to evaluate the duration of a reduced maximal voluntary bite force after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH & Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units).
详细描述
This study aimed to evaluate the duration of a reduced maximal voluntary bite force (MVBF) after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH & Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units). A control group did not receive any intervention. MVBF was measured in Newtons using a strain gauge meter at the incisors and first molars. The intervention group was comprised of individuals seeking aesthetic treatment for masseter reduction (n = 20), and the control group (n = 12) comprised of volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.
排除标准
- •Conditions or drugs affecting the central nervous system.
研究组 & 干预措施
Intervention
Intervention with single botulinum neurotoxin injection into masseter.
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Change of bite force
时间窗: Baseline, 4 weeks, 3 months, 6 months, 12 months.
Maximum voluntary bite force measured in Newtons at baseline, and change of bite force compared to baseline.
次要结局
未报告次要终点