Efficacy of Hard Splint Vs Conservative Therapy in the Pain Management of Temporomandibular Joint Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Pain Intensity
研究概览
简要总结
The purpose of this study is to compare the efficacy of a hard occlusal splint versus conservative therapy (using topical Ibuprofen gel and counseling) in the management of patients with temporomandibular (TMJ) joint disorders. The study aims to determine which treatment is more effective at reducing pain, measured by Visual Analogue Scale (VAS), at 1 week and 4 weeks post therapy.
详细描述
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 (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
- 否
入选标准
- •Patients diagnosed with TMJ disorders based on clinical examination. Patients willing to participate and provide informed consent.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Hard occlusal splint (Device)
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).
干预措施: Counseling and Habit Modification (Other)
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).
干预措施: Topical Ibuprofen gel (Drug)
结局指标
主要结局
Pain Intensity
时间窗: 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.
次要结局
未报告次要终点
研究者
Ayesha Urooj
FCPS Trainee, Department of Prosthodontics
Khyber College of dentistry