Double-blind, Placeboa-controlled, Randomized Clinical Trial of the Safety and Efficacy of Botulinum Toxin (BOTOX) in Bruxism.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Bruxism Questionnaire Baseline and at Week 4
研究概览
简要总结
The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.
详细描述
Bruxism represents involuntary movements of the jaw muscles, resulting in tooth grinding and clenching. Generally it occurs during sleep, but occasionally can be present during the day, so called awake bruxism. Bruxism is a common condition, affecting approximately 8% of all people. It is not known what causes bruxism but it may result in tooth damage, jaw pain, headaches, poor quality sleep and may bother your partner's sleep at night due to the tooth grinding noise. There is no generally accepted treatment for bruxism. Mouth guards and several medications have been tried, but they generally did not work or caused side effects.
Botulinum toxin "Botox" is a natural toxin, which weakens the muscles when injected in very small amounts. It is currently approved and used for the treatment of various conditions involving abnormal muscle spasms, such as neck twisting (torticollis), twitching of the face (hemifacial spasm) or eyes (blepharospasm), headaches, muscles stiffness following strokes, and it has also been used cosmetically for wrinkle removal.
Since bruxism is caused by involuntary spasms of the jaw muscles, botulinum toxin has been tried, initial results showing that it is safe and effective. The injections generally take one week to start working and 2 weeks for a full effect, which lasts on average 12-16 weeks, and slowly wear off. The injections are generally repeated every 3-4 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18 and 80 years old with a diagnosis of bruxism, based on the standard criteria.
- •If the subject is a female of childbearing age, she must have had a hysterectomy, tubal ligation, or otherwise be incapable of pregnancy, or have practiced a method of contraception (hormonal contraceptives, spermicidal barrier, intrauterine device, partner sterility) at least one month prior to study entry. Any female of childbearing age will have a urine pregnancy test one week prior to the treatment (visit 2).
- •Ability of the patient or guardian to sign and understand informed consent.
- •Ability to follow and comply with study directions.
排除标准
- •Coexistence of active psychosis, other active psychiatric disease or cognitive impairment.
- •Coexistence of serious co-morbid conditions.
- •Exposure to any botulinum toxin preparation within the past 6 months.
- •Participation in another experimental therapeutic protocol within 30 days.
- •Any medical condition in which the administration of botulinum toxin is contraindicated, including myasthenia gravis, amyotrophic lateral sclerosis or other neuromuscular diseases.
- •History of dysphagia.
- •History of botulism.
- •A condition or situation in which the investigators view will confound the ability of the subject to participate in the study.
- •Patients or guardian who are unable to understand and sign informed consent.
- •Patients who do not meet inclusion criteria.
- •Patients in whom it is felt that a major portion of overall sleep morbidity is not related to bruxism.
研究组 & 干预措施
Placebo
Placebo arm
干预措施: Placebo arm (Drug)
botulinum toxin type A
Active arm
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Bruxism Questionnaire Baseline and at Week 4
时间窗: baseline versus week 4
Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\]. This is compared to week 4 assessments. The bruxism questionnaire consists of 8 questions. Each question can be scored between 0-3 points for a total possible scoring of 24 points. The minimum score is 0. The maximum score if 24. A score of 3 or less means non-temporomandibular disorder. A score of 4 or more means temporomandibular disorder.
次要结局
- Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4(Baseline to week 4)
- Clinical Global Impression (CGI)(baseline versus week 4)
- Visual Analog Scale of Change (VAS)-Pain Scale(baseline versus week 4)
- Visual Analog Scale of Change (VAS)-Pain(Baseline versus week 4)
研究者
Joseph Jankovic
Professor
Baylor College of Medicine