Comparative Evaluation Of The Effectiveness Of Conventionally Fabricated Occlusal Splints With Computer-Aided Design And Computer-Aided Manufacturing (Cad/Cam) 3d-Printed Occlusal Splints In Reducing Pain, Improving Mouth Opening And Lateral Jaw Movements In Patients With Temporomandibular Disorders: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in jaw pain measured on the Visual Analogue Scale (VAS), comparing baseline to follow-up after splint therapy in adults with myogenic temporomandibular disorders. This captures the core therapeutic target of symptom relief for muscle-related TMD pain
研究概览
简要总结
This randomized controlled trial compares traditional occlusal splints with CAD CAM 3D printed splints in patients with myogenous temporomandibular disorders to assess pain reduction mouth opening and lateral jaw movements. TMD commonly causes jaw pain limited movement and reduced quality of life and stabilization splints are a standard conservative treatment. Conventional PMMA splints are labor intensive and can have defects while digital workflows using intraoral scanning and CAD CAM aim to improve fit comfort and efficiency. The study aims to determine whether CAD CAM splints provide equal or superior clinical outcomes versus conventional splints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •• Patients irrespective of gender will be selected.
- •• Patients aged between 18-55 years will be selected.
- •• Patients with temporomandibular disorder pain.
- •• Patients with myofascial or temporomandibular joint pain.
- •• Patients with symptoms indicated for treatment with occlusal splints.
- •• Volunteer patients who agree to give informed consent will be considered as individuals for the research.
排除标准
- •Patient with recent facial and temporomandibular joint trauma.
- •Patients with autoimmune diseases involving temporomandibular joint.
- •Patients with systemic conditions (e.g., diabetes, arthritis).
- •Patient using medication affecting central nervous system.
- •Patients wearing orthodontic appliance.
结局指标
主要结局
Reduction in jaw pain measured on the Visual Analogue Scale (VAS), comparing baseline to follow-up after splint therapy in adults with myogenic temporomandibular disorders. This captures the core therapeutic target of symptom relief for muscle-related TMD pain
时间窗: 3 Months
次要结局
未报告次要终点
研究者
Dr Mohit Mulchandani
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur.