To assess and compare the effectiveness of a multidisciplinary approach versus occlusal splints alone in reducing pain associated with temporomandibular disorders (TMDS): a randomized clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- pain intensity, mandibular range of motion
研究概览
简要总结
This randomized clinical trial aims to compare a multidisciplinary approach combining occlusal splint therapy, physiotherapy, and mindfulness-based intervention with occlusal splints alone in reducing TMD related pain and improving function. A total of 154 patients aged between18 to 40 years diagnosed using RDC TMD criteria will be randomly assigned by block randomization to either the splint only group or the multidisciplinary group. Interventions will be conducted over four weeks, with follow-ups at baseline, 2 weeks, 1 month, and 2 months. Pain intensity, mandibular range of motion, and psychological well-being will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who experienced common symptoms of TMD (i.e. impaired range of movement, impaired TM-joint function, muscle pain, TM-joint pain, or pain on movement of the mandible).
- •Patients aged between 18 to 40 years.
- •Patients willing to receive treatment after informed consent.
排除标准
- •Patients below the age of 18 years and above the age of 40 years.
- •Patients with complete or removable prosthesis with distal extensions on which it is not possible to fabricate a retentive splint.
- •Patients already having received medical, pharmacological or any form of treatments for TMD.
- •Individuals with recent facial or cervical trauma.
- •Patients under treatment for any major psychological disorders.
- •Symptoms related to disease in other components of the stomatognathic system e.g., toothache, neuralgia).
- •Cases with congenital abnormality, concomitant inflammatory or neoplastic conditions.
- •Patients not willing to participate after informed consent.
结局指标
主要结局
pain intensity, mandibular range of motion
时间窗: baseline, 2 weeks, 1 month, 2 months
次要结局
- psychological status(baseline, 2 months)
研究者
Akshaya Kumar Patra
Kalinga Institute Of Dental Sciences