Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
Comparative Efficacy of Conventional, 3D-Printed, and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders: A Randomized Clinical Trial
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.
研究概览
地位
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Dr. Subhadeepa Paul
- 电话号码:+918638461860
- 邮箱:Subhadeepa01@gmail.com
研究联系人备份
- 姓名:Dr. Harneet Singh, MDS
- 电话号码:+919315903300
- 邮箱:drharneetomdr@gmail.com
学习地点
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Haryana
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Rohtak、Haryana、印度、124001
- Post Graduate Institute of Dental Sciences, Rohtak
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接触:
- Dr. Harneet Singh, MDS
- 电话号码:+919034900501
- 邮箱:drambikagupta79@rediffmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Patients presenting with clinical symptoms of TMJ pain disorders were diagnosed using the DC/TMD criteria.
- Age between 18 and 60.
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Conventional Stabilization Splints
Patients will be given conventional hard stabilization splints.
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Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.
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有源比较器:3D Printed stabilization splints
Patients will be given single material 3D printed stabilization splints made of PETG.
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3d printed stabilization splint for treatment of temporomandibular joint disorders.
其他名称:
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实验性的:Hybrid Stabilization Splint
Patients will be given Novel Hybrid stabilization splints made of PETG and TPU.
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3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Visual Analog Scale (VAS)
大体时间:Baseline, 1 week, 2 weeks, 4 weeks
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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.
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Baseline, 1 week, 2 weeks, 4 weeks
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Maximum Mouth Opening
大体时间:Baseline, 1 week, 2 weeks, 4 weeks
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To evaluate functional improvement by Measuring the change in Maximum Mouth Opening (MMO) in millimetres from baseline to 1 month.
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Baseline, 1 week, 2 weeks, 4 weeks
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Maximum Bite Force
大体时间:baseline, 1 week, 2 weeks, 4 weeks
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To quantify masticatory efficiency by measuring changes in Maximum Bite Force (MBF) using a bite force analyser device.
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baseline, 1 week, 2 weeks, 4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient Compliance
大体时间:Baseline, 1 week, 2 weeks, 4 weeks
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To evaluate patient compliance and comfort using Likert Scale.
The Likert Scale is a 5-point scale where 1 is the minimum score and 5 is the maximum score.
Score 1 indicates very dissatisfied and Score 5 indicates very satisfied.
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Baseline, 1 week, 2 weeks, 4 weeks
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合作者和调查者
调查人员
- 研究主任:Dr. Harneet Singh, MDS、Post Graduate Institute of Dental Sciences, Rohtak
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Subhadeepa Omr 26/39
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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