Influence of Stabilization Splint Thickness on The Temporomandibular Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 主要终点
- Presence of intra-capsular temporomandibular disorders
研究概览
简要总结
The aim of the study is assessing the effect of the stabilization splint (SS) thickness on the temporomandibular disorder's and their symptoms; such as muscle or temporomandibular joint (TMJ) pain, TMJ sounds, and limitation of mouth opening.
详细描述
Participants are selected from patients who applied to the clinic with the complaint of temporomandibular disorders (TMDs). Symptoms are evaluated with RDC/TMD forms. Regarding the treatment plan, patients are divided into two groups; 2 mm-thick splint group (2 mm-TSG) and 4 mm-thick splint group (4 mm-TSG). They used SS's at night for 8 hours, and they were recalled on 1st, 2nd, 3rd, and 6th months after splint insertion. Their symptoms and splints are checked.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No need for orthodontic treatment
- •Maximum 2 teeth have been extracted
- •Having efficient occlusal contacts
- •Patients in the axis 1 and axis 2 groups according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
排除标准
- •Treated with stabilization splint before
- •Partial edentulous patients
- •Patients in the axis 3 group according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
结局指标
主要结局
Presence of intra-capsular temporomandibular disorders
时间窗: Up to 6 months
II.a Disc displacement with reduction: 1. No pain in the joint 2. Reproducible (All clicks must be reproduced 2 out of 3 consecutive trials) click on excursion with either opening or closing click 3. With click on opening and closing (unless excursive click confirmed): * Click on opening occurs at ≥ 5 mm interincisal distance than on closing * Clicks eliminated by protrusive opening II.b Disc displacement without reduction with limited opening: 1. History of locking or catching that interfered with eating 2. Absence of TMJ clicking 3. Unassisted opening (even painful) ≤ 35mm and passive stretch ≤ 4mm 4. Contralateral excursion \< 7mm II.c Disc displacement without reduction without limited opening: 1. History of locking or catching that interfered with eating 2. The presence of TMJ sounds excluding DDR clicking 3. Unassisted opening (even painful) \> 35mm and passive stretch \> 4mm 4. Contralateral excursion ≥ 7mm
Presence of myofascial pain
时间窗: Up to 6 months
Myofascial pain and myofascial pain with limited opening are in the Group I according to the RDC/TMD. I.a Myofascial pain: 1. Reported pain in masticatory muscles (In the jaw, temples, face, preauricular area, or inside the ear, at rest or function) 2. Pain on palpation in at least 3 sites (There are 20 sites (ten on each side): posterior, middle and anterior Temporalis; origin, body and insertion of Masseter; posterior mandibular region; Submandibular region; lateral Pterygoid; tendon of Temporalis), one of them at least in the same side of the reported pain I.b Myofascial pain with limited opening: 1. Myofascial pain 2. Pain-free unassisted 3 opening\< 40 mm and Passive 4 stretch ≥ 5 mm
次要结局
- Presence of TMJ sounds(Up to 6 months)
- Limitation of jaw movements(Up to 6 months)