Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation: Double-blind, Randomized, Placebo Controlled Trail Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Frequency of luxation
研究概览
简要总结
Assessment of the effect of Botulinum toxin injection on the frequency of luxation and TMJ Pain in patients with TMJ dislocation either chronic recurrent dislocation or subluxation
详细描述
Diagnostic procedure:
- Patient questionnaire: a questionnaire will be recorded by the examiner including the Chief complaint, Personal data, and Medical history.
- Consent: Informed consent will be obtained from patients to participate in the study.
- Clinical examination: TMJ examination with specific emphasis on the TMJ regarding pain, clicking, maximum inter-incisal mouth opening, lateral excursions, and muscle examination is done (Inspection and palpation).
o operative procedures:
• The surgical field will be scrubbed and prepared in a standard sterile fashion using alcohol and topical anesthesia is applied at point of needle insertion
A-Botulinum Toxin Type A injection:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with TMJ habitual or recurrent dislocation
- •Age ≥ 18 years
- •The willingness of the patient to receive relative painful injections and to follow instructions
排除标准
- •Patients with neurogenic cause of TMJ Hypermobility.
- •Drug-induced TMJ Hypermobility
研究组 & 干预措施
botulinum toxin type A injection in lateral pterygoid muscle
Botulinum toxin type A vial will be reconstituted with normal saline to obtain a 10 U/0.1 ml solution, 0.25 ml of this solution containing 25 U BTX-A will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length.
The Lateral pterygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection. According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with BTX-A
干预措施: Botulinum toxin type A (Drug)
Placebo "Saline 0.9%" injection in lateral pterygoid muscle
0.25 ml of normal saline will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length.
The Lateral pterygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection. According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with normal saline
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Frequency of luxation
时间窗: 6 months
Postoperative frequency of luxation is measured by number of luxation per day in organized sheet
Maximum Mouth opening
时间窗: 6 months
Postoperative Maximum Mouth opening is measured by digital caliper in follow up intervals" 1 week, 1 month, 3 month, 6 month"
次要结局
- Lateral mandibular movement(6 months)
研究者
Amr Ehab Shaaban
Amr Shaaban, BDS "Prinicipal Investigator"
Cairo University