Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- number of episodes of nocturnal bruxism
研究概览
简要总结
Bruxism is defined as a parafunction that consists of a clenching of the jaw and/or grinding of the teeth. It can occur when an individual is sleeping or awake or it can be mixed.
Most often, it is primary or idiopathic bruxism, however when it is related to a cause it is qualified as secondary.
Primary bruxism is a condition that is not well known to the general public, but I is very widespread (12% of the adult population). In addition, it can alter quality of life, as a result of associated sleep disorders, concentration disorders, daytime fatigue, chronic pain, etc.
The current treatment for this condition is only symptomatic. Currently, one of the most effective treatments is the intramuscular injection of botulinum toxin A in the muscles of mastication. The progressive anticholinergic action results in a reduction of functional signs (dental pain, periodontal pain, temporomandibular joint pain, tension headaches, neck pain) and physical signs (reduction of the mass of the injected muscles, alba linea, tongue scalloping, limitation or stability of dental damage).
However, these clinical data are practically not objectified in daily practice. Objective criteria would make it possible to measure the effectiveness of the treatment, to follow the patient, and to identify the early symptoms in order to prevent a recurrence.
The aim of the prospective study is to concretely measure the strength and electromyographic activity of the muscles of mastication before and after botulinum toxin injection.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who has given written consent.
- •Patient between 18 and 64 years of age.
- •Patient who has never received botulinum toxins
- •Symptomatic patient in the context of bruxism in failure to the usual treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer)
- •Woman of childbearing age using an effective method of contraception
- •Symptomatic patients in the context of bruxism, without a maxillary disocclusion retainer.
排除标准
- •Protected Adult
- •Patient not affiliated to the national health insurance system
- •Pregnant or breastfeeding woman
- •Refusal to take part in the study
- •Neuromuscular diseases, including Myasthenia gravis, Myopathies, Amyotrophic Lateral Sclerosis. Lambert-Eaton Syndrome, patients with peripheral motor neuropathies, patients with underlying neurological disorders.
- •Patients with a history of cardiovascular disease
- •Patients with epilepsy or a previous seizure episode
- •Neurogenic impairment of the face (including facial paralysis, polyradiculoneuritis)
- •History of dysphagia or pulmonary aspiration
- •Injection site infection (masseter and temporal)
- •Hypersensitivity or allergy to botulinum toxin or any of its excipients.
- •Treatment with aminoglycosides or anticholinesterase agents.
研究组 & 干预措施
Symptomatic patients in the context of bruxism
干预措施: Botulinum toxin injection (Drug)
Symptomatic patients in the context of bruxism
干预措施: QOL-Brux (Other)
Symptomatic patients in the context of bruxism
干预措施: Muscular strength of the jaw (Other)
Symptomatic patients in the context of bruxism
干预措施: Intensity and frequency of episodes of nocturnal bruxism (Other)
Symptomatic patients in the context of bruxism
干预措施: visual analogue pain scale (Other)
Symptomatic patients in the context of bruxism
干预措施: Endobuccal and linea alba photographs (Other)
结局指标
主要结局
number of episodes of nocturnal bruxism
时间窗: 1 month after treatment by botulinum toxin injection
measurement of the number of bruxism episodes via a portable electromyogram we expect a significant improvement in the number of nocturnal bruxism episodes (decrease in relation to time 0)
次要结局
未报告次要终点