Evaluation of Botulinum Toxin Injection in Treatment of Bruxism
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 12
- 主要终点
- Change in electromyographic activity of temporalis and masseter muscles bilaterally.
研究概览
简要总结
Aim of this study is to evaluate the effect of botulinum toxin type A (Xeomin®) on patients complaining from bruxism.
The study will be a one arm clinical trial. Twelve subjects reporting bruxism irresponsive to conventional treatment modalities will be recruited and will be injected with botulinum toxin A (Xeomin®) in both masseter and temporalis muscles. Pain levels, Electromyographic activity and maximum occlusal force will be recorded in the subjects before injection and at 1 and 3 months after injection to determine the effect of treatment
详细描述
Bruxism is a parafunctional activity of the masticatory muscles, characterized by jaw clenching and/or tooth grinding. It was suggested in international consensus conference that bruxism should have two distinct definitions. Sleep bruxism is a muscular action, either rhythmic or not, that takes place while sleeping, and an Awake bruxism which is a muscle disorder characterized by repeated or prolonged teeth contact with clenching of the jaw.
Bruxism is a highly prevalent condition. More than 85% of the general population admit to bruxism at some time during their life. According to reports, the prevalence of awake bruxism is about 24% in the adult population, while the prevalence of bruxism when sleeping is estimated to be around 16% of the same population.
The three muscles that responsible for the jaw closure and the majority of the biting force is the masseter, temporalis, and medial pterygoid muscles. About 43% of the intrinsic strength of jaw closure comes from the masseter, 36% from the temporalis, and 21% from the medial pterygoid.
The diagnosis of bruxism is made on the basis of self-reporting of clenching or grinding the teeth, as well as evaluating tooth mobility, tooth wear, bruxism-related sounds, or jaw muscle pain and other clinical findings of the temporo-mandibular joint (TMJ).
Bruxism has been noted in dentistry as a risk factor for tooth fracture and dental prosthesis damage, periodontal disease and possibly pain in the teeth, jaw, masticatory muscles, and temporo-mandibular joint. The etiology and pathophysiology of bruxism are still unknown, despite several potential causes have been suggested, including emotional stress, neurological diseases, specific medications, and occlusal interferences.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 20 and 60 years of age.
- •Pain related to the masseter muscles and TMJ area due to bruxism.
- •Patient who has never received botulinum toxins.
- •Patient who did not respond to the conventional treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer).
排除标准
- •Pregnant or breastfeeding women.
- •Neuromuscular diseases, including neurogenic impairment of the face and patients with underlying neurological disorders.
- •Patients with epilepsy or a previous seizure episode.
- •Injection site infection (masseter or temporalis).
- •Hypersensitivity or allergy to botulinum toxin or any of its excipients.
研究组 & 干预措施
One Group
Patients will be injected with 50 MU of botulinum toxin and Surface qualitative Electromyography, maximum bite force and visual pain scale will be taken before and after 1, 3 months
干预措施: Xeomin (Drug)
结局指标
主要结局
Change in electromyographic activity of temporalis and masseter muscles bilaterally.
时间窗: Assessment will be done before the injection versus 1 and 3 months after injection
Analyze the electromyographic activity of temporalis and masseter muscles bilaterally. The acquisitions will be performed twice with the rest position of the mandible (RPM) for 10 seconds, in maximal intercuspal position for 5 seconds, and maximal teeth clenching with 10-mm thick cotton rolls between the posterior teeth for 5 seconds, bilaterally, and the median of values will be obtained. The unit of measurement used in the Electromyographic records will be microvolts (μV).
次要结局
- Change in maximum bite force(Assessment will be done before the injection versus 1 and 3 months after injection)
- Change in Pain Assessment(Assessment will be done before the injection versus 1 and 3 months after injection)
- Change in Bruxism symptom questionnaire(questionnaire will be done before the injection versus 1 and 3 months after injection)
研究者
Walaa Ali Elwakil
Lecturer
Alexandria University