Hard Splint Vs Conservative Therapy for TMJ Pain Management
Efficacy of Hard Splint Vs Conservative Therapy in the Pain Management of Temporomandibular Joint Disorders
研究概览
地位
详细说明
This randomized controlled trial will be conducted at the department of Prosthodontics, Khyber College of Dentistry, Peshawar. Patients diagnosed with TMJ disorders based on clinical examination will be randomly assigned to two groups.
GROUP A: Patients will receive a hard occlusal splint made of heat cure acrylic resin to be worn at night.
GROUP B: Patients will receive conservative therapy consisting of topical 5% Ibuprofen gel application three times daily and counseling regarding habit modification(soft diet ,avoiding wide mouth opening).
Pain intensity will be recorded for both groups at baseline , 1 week and 4 week followup visit using a 10cm Visual Analogue Scale. the data will be analyzed using SPSS version 22.0.
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Patients diagnosed with TMJ disorders based on clinical examination. Patients willing to participate and provide informed consent.
Exclusion Criteria:
- Patient with a history of recent TMJ surgery or trauma. Patients with systemic joint diseases (e.g Rheumatoid Arthritis, Osteoporosis, Osteopetrosis, Osteomalacia).
Patients currently using other occlusal appliances or undergoing active orthodontic treatment.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Hard Oclussal Splint
Patients in this group will be provided with hard occlusal splint made of heat cure acrylic resin, to be worn at night for a duration of 6 months.
|
A custom fabricated heat cure acrylic resin splint
|
|
有源比较器:Conservative Therapy
Patients in this group will receive conservative management consisting of topical 5% Ibuprofen gel applied three times daily and counseling regarding habit modification (soft diet, avoiding wide mouth opening).
|
Counseling regarding soft diet and avoidance of wide mouth opening.
5% Ibuprofen gel applied three times daily over the affected TMJ area.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain Intensity
大体时间:baseline, 1 week and 4 weeks
|
Pain will be assessed using a 10cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents worst possible pain.
|
baseline, 1 week and 4 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.