Comparative effectiveness of Soft Splint, Centric Stabilization Splint, and Hydrostatic Splint in patients exhibiting Temporomandibular disorders- A Randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Improvement in mandibular mobility, TMJ Function.
研究概览
简要总结
Occlusal splint treatment is commonly used to treat patients with temporomandibular disorders (TMDs), with efficacy ranging between 70% and 90%. The aetiology of TMD is multifaceted, with factors such as predisposing, initiating, and perpetuating factors. Hard, soft, and hydrostatic splints are used to relieve muscular soreness in patients with TMD. Electromyography (EMG) is used to assess muscle activity and evaluate the effectiveness of splint therapy on the masticatory muscle complex. This study aims to compare the effectiveness of hard, soft, and hydrostatic splints in treating patients with TMD using more parameters and EMG. The study will be a double-blinded, randomized controlled clinical trial on 45 patients with TMD pain/clicking/other joint symptoms. The sample size will be based on the Research Diagnostic Criteria for Temporo-Mandibular Disorders (RDC/TMD). The study aims to evaluate the effectiveness of a new approach to managing temporomandibular disorders (TMDs) using a hydrostatic splint. The study uses a Bio EMG Machine, BioPAK software, a computer, alginate impression material, dental stone, interocclusal record making material, face bow, semi- adjustable articulator, clear heat cure acrylic resin, and soft splint sheet. The splint is made using a combination of a centric stabilization splint, a soft splint, and a hydrostatic splint. The splint is worn for 6 months and the parameters for TMJ function are reviewed at regular follow-up appointments. The study’s statistical evaluation uses the Tukey test and Kruskal-Wallis H-test. The study aims to assess mandibular mobility, TMJ dysfunction, and evaluate the Masticatory Muscles EMG before and after treatment of splint therapy in patients with Temporomandibular Disorders (TMD). Participants will wear splints according to instructions, and baseline data will be collected. The study is voluntary, and participants may benefit from improving TMD symptoms and reducing facial masticatory muscle pain. No financial reimbursement is provided, and participants can withdraw at any time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient’s age ranging from 18 years to 45 years (both included) were included in our study.
- •Patients were recruited irrespective of sex, religion, caste or socioeconomic status.
- •RDC/TMD classification among Axis 1 were selected.
- •Fully dentate or at least had sufficient occlusal stops, no more than two posterior teeth missing in each quadrant (excluding third molars) were selected.
排除标准
- •Completely edentulous patients or patients with no posterior occlusal stops were excluded from the study.
- •Patents having reduced mouth opening were excluded from the study.
- •Patients undergoing Orthodontic treatment were excluded from the study.
- •Patients with pain because of systemic disease (eg; rheumatoid arthritis, etc) were also excluded from the study.
结局指标
主要结局
Improvement in mandibular mobility, TMJ Function.
时间窗: At 1st week ,1st month, 3nd month and 6th month to review.
次要结局
- Better life quality and better mastication ability(At the end of 3 months)
研究者
Dr Abhishek Kumar Gupta
ESIC Dental College and Hospital