Comparative Evaluation of the Efficacy of TMD splint constructed using AD2 articulator, with and without Physiotherapy, in the management of Mild to Moderate TMD cases with Conventional TMD Splint therapy- A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Decrease in TMD severity and
研究概览
简要总结
This study is a randomized, parallel-group, active control outcome assessor-blinded, comparing the efficacy of TMD (Temporomandibular Disorders) Splint fabricated using the AD2 Articulator system with and without physiotherapy in the management of TMDs with Conventional Splint therapy in 48 mild to moderate TMD cases. The primary outcomes will be a decrease in the severity of TMDs evaluated using the Helkimo index and Treatment Duration Control Index and Pain evaluated using the Chronic Pain Grading Score Index. The secondary outcomes will be Treatment duration, Mouth opening measured using Digital Vernier Calliper and Quality of Life evaluated using WHO Oral Health Impact Profile-14 questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with mild to moderate TMDs.
排除标准
- •Patients having TMDs of severe grade.
- •Patients who underwent surgery for TMDs Patients who underwent surgery for condylar morphology modification Patients with Condylar dysplasia Patients with faulty Dental Restorations patients with Trauma to Temporomandibular Joint.
结局指标
主要结局
Decrease in TMD severity and
时间窗: 3 weeks | 6 weeks | 12 weeks | 18 weeks
Associated Pain
时间窗: 3 weeks | 6 weeks | 12 weeks | 18 weeks
次要结局
- Time Duration(Mouth Opening)