Combination Treatment of Occlusal Splint Appliance and Granisetron Injection Into the Masseter Muscle for Management of Myofascial Pain Related to Temporomandibular Disorders: A Randomized Controlled Parallel-arm Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain intensity assessed using the Visual Analogue Scale (VAS).
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a combination of occlusal splint therapy and granisetron injection into the masseter muscle is effective in managing myofascial pain related to temporomandibular disorders (TMD). The study will also compare this combination treatment to occlusal splint therapy alone and to occlusal splint therapy combined with lidocaine injection.
The main questions this study aims to answer are:
- Does adding granisetron injection to occlusal splint therapy reduce myofascial pain more effectively than occlusal splint therapy alone?
- How does granisetron injection compare to lidocaine injection when combined with occlusal splint therapy?
- Does the combination treatment improve mandibular movement and reduce joint clicking?
- Are there any local or systemic side effects associated with granisetron or lidocaine injections?
Researchers will compare three groups to evaluate treatment effectiveness:
- Occlusal splint therapy alone
- Occlusal splint therapy plus granisetron injection
- Occlusal splint therapy plus lidocaine injection
Participants will:
- Wear an occlusal splint as part of their treatment
- Attend follow-up visits after 1 week, 1 month, 3 months, and 6 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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 19 - 45 years.
- •Diagnosis of myofascial pain according to the Research Diagnostic Criteria for TMD Axis I (RDC/TMD).
- •Pain upon digital palpation of the masseter and/or the temporalis muscles.
- •Patients with disc displacement with or without reduction in any of the TMJs.
- •Co-operative patients.
排除标准
- •Diagnosed systemic muscular or joint diseases (e.g. fibromyalgia, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis).
- •Whiplash-associated disorder.
- •Neuropathic pain or neurological disorders (e.g. myasthenia gravis, orofacial dystonia).
- •History of psychiatric disorders.
- •Pain of dental origin.
- •Use of muscle relaxants or other medication that might influence the response to pain.
- •Pregnancy or lactation.
- •Known hypersensitivity to granisetron or lidocaine
研究组 & 干预措施
Only occlusal splint group
This group will receive occlusal splint therapy only.
干预措施: occlusal splint (Device)
Occlusal splint and granisetron injection group
This group will receive occlusal splint therapy in addition to multiple injection of granisetron that will be administered via intramuscular injection at a dose of 0.5 mL.
干预措施: Granisetron (Drug)
Occlusal splint and granisetron injection group
This group will receive occlusal splint therapy in addition to multiple injection of granisetron that will be administered via intramuscular injection at a dose of 0.5 mL.
干预措施: occlusal splint (Device)
Occlusal splint and lidocaine injection group
This group will receive occlusal splint therapy in addition to multiple injection of lidocaine that will be administered via intramuscular injection at a dose of 0.5 mL.
干预措施: lidocaine (Drug)
Occlusal splint and lidocaine injection group
This group will receive occlusal splint therapy in addition to multiple injection of lidocaine that will be administered via intramuscular injection at a dose of 0.5 mL.
干预措施: occlusal splint (Device)
结局指标
主要结局
Pain intensity assessed using the Visual Analogue Scale (VAS).
时间窗: Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.
Pain intensity will be assessed using a Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain. Participants will mark their pain at rest and during jaw movements.
Presence or absence of temporomandibular joint clicking sound assessed by clinical examination during mandibular movement.
时间窗: Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.
次要结局
- Masseter muscle electrical activity assessed using surface electromyography (sEMG).(Preoperatively and 6 months postoperatively.)
- Maximum interocclusal opening measured in millimeters using a caliper.(Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.)
- Range of lateral mandibular movement measured in millimeters using a caliper.(Preoperatively and 1 week, 1month, 3 months and 6 months post operatively.)
研究者
Sarah Elmaghraby
Lecturer, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
Mansoura University