KCT0004459
已完成
未知
A randomized controlled trial of Botulinum Toxin Injection for treating Sleep Bruxism
Yonsei University Health System, Dental Hospital0 个研究点目标入组 30 人待定
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Yonsei University Health System, Dental Hospital
- 入组人数
- 30
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\) Adult male and female subjects at the age of \= 18 years old
- •2\) The subjects had the following clinical signs and symptoms for SB: (1\) a history of tooth grinding occurring at least three3 nights per week; (2\) experience of morning jaw stiffness; and (3\) clinical presence of tooth wear.
- •3\) Subject who have signed the written informed consent voluntarily.
排除标准
- •1\) Previous treatment with botulinum toxin of any serotype into both the masseter and the temporalis muscles for the past one year
- •2\) Patients with sleep bruxism appearing as part of Mandibular dyskinesia, dystonia
- •3\) Patients with sleep bruxism that appear as brain damage or drugs
- •4\) Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton\-Lambert syndrome, amyotrophic lateral sclerosis)
- •5\) Patients who take certain medications like Aminoglycoside antibiotics, curare\-like agents, or drugs that inhibit neuromuscular function (muscle relaxers, anticholinergic, benzodiazepines, benzamides, tetracyclines, lincomycins, etc.) within 4 weeks prior to screening visit
- •6\) Known allergy or hypersensitivity to botulinum toxin preparation
- •7\) Female who are pregnant, lactating, or likely to become pregnant, and who are not willing to use an acceptable form of contraception.
- •8\) Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
- •9\) Participation in another interventional clinical study within the last 30 days or 5 half\-lives of the drug, whichever is longer, of entry into this study
结局指标
主要结局
未指定
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