Comparative Efficacy of Conventional, 3D-Printed, and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Occlusal splint therapy is a well-established conservative approach for the management of temporomandibular disorders (TMDs); however, variability in clinical outcomes suggests that no single splint design is universally optimal. Conventional chairside stabilization splints are widely used and allow immediate intraoral adjustments; however, they are technique-sensitive and may compromise long-term fit and patient comfort. Conversely, 3D-printed occlusal splints provide superior precision, reproducibility, and material stability; however, their uniformly rigid structure may limit initial comfort and patient compliance, particularly in patients with acute pain or muscle tenderness.
To address these limitations, the researchers intend to develop an innovative hybrid occlusal splint i.e. Dual material 3D printed stabilization splint, that integrates both hard and soft components. This design aims to combine the biomechanical stability and occlusal precision characteristic of rigid splints with the cushioning effect and enhanced comfort provided by soft splints. The objective is to improve adaptation, compliance, and the sustained therapeutic efficacy of the splint.
详细描述
Temporomandibular disorders (TMDs) are a diverse group of musculoskeletal and neuromuscular conditions affecting the temporomandibular joint (TMJ), masticatory muscles, and associated structures, leading to pain, functional limitations, and impaired quality of life.5 They encompass more than 30 different conditions that may involve the TMJ, the surrounding masticatory muscles (such as the masseter, temporalis, and pterygoid muscles), or a combination of both.Occlusal splints have long been a cornerstone of TMD management due to their reversibility, simplicity, and efficacy in redistributing occlusal forces, reducing bruxism, and promoting neuromuscular adaptation.16 Understanding their diverse presentation, underlying risk factors, and biopsychosocial context is essential for effective assessment, diagnosis, and management.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with clinical symptoms of TMJ pain disorders were diagnosed using the DC/TMD criteria.
- •Age between 18 and
- •The same number of original molars was used to avoid affecting periodontal proprioception and bite force.
- •The Patient's consent to participate in the study.
排除标准
- •Pregnancy
- •Not willing to participate in the study
- •Healing disorders or systemic diseases where healing is compromised.
- •Allergic to PMMA, TPU, PETG or any other 3D printing or conventional prosthetic material.
- •Patients with epilepsy or any other neurological disorders.
- •Systemic Arthritis or any other osteo-degenerative disorder.
- •Acute TMJ trauma or fracture in < 30 days.
- •Any obvious dental decay or periodontal disease to which fascial pain could be attributed.
- •Patient with psychiatric disorder or on anti-anxiety or anti-depressant drugs.
- •Patients with dental implants.
- •Any systemic condition associated with widespread pain such as in fibromyalgia.
研究组 & 干预措施
Conventional Stabilization Splints
Patients will be given conventional hard stabilization splints.
干预措施: Conventional Stabilization Splints (Device)
3D Printed stabilization splints
Patients will be given single material 3D printed stabilization splints made of PETG.
干预措施: 3d printed Stabilization splint (Device)
Hybrid Stabilization Splint
Patients will be given Novel Hybrid stabilization splints made of PETG and TPU.
干预措施: Novel hybrid stabilization splint (Device)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Baseline, 1 week, 2 weeks, 4 weeks
To evaluate and contrast pain relief by using the Visual Analog Scale (VAS).The scale ranges from 0 to 10 where 0 is the minimum VAS score and 10 is the maximum score. Score of 0 indicates no pain and score of 10 indicates maximum pain intensity.
Maximum Mouth Opening
时间窗: Baseline, 1 week, 2 weeks, 4 weeks
To evaluate functional improvement by Measuring the change in Maximum Mouth Opening (MMO) in millimetres from baseline to 1 month.
Maximum Bite Force
时间窗: baseline, 1 week, 2 weeks, 4 weeks
To quantify masticatory efficiency by measuring changes in Maximum Bite Force (MBF) using a bite force analyser device.
次要结局
- Patient Compliance(Baseline, 1 week, 2 weeks, 4 weeks)