Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders
2026年8月18日 更新者：Ting-Yu Huang, D.D.S.、En Chu Kong Hospital
Development of an Integrated Evaluation-to-Treatment Framework to Enhance Clinical Efficiency and Effectiveness in Temporomandibular Disorders
This study aims to improve clinical efficiency and effectiveness in treating Temporomandibular Disorders (TMD).
The researchers will integrate machine learning technology with clinical examination data, CBCT, and MRI to identify the core underlying issues of each patient.
Based on this precise, AI-assisted diagnosis, the study will implement a tailored treatment framework.
The final goal is to develop predictive algorithms that can determine MRI necessity while ensuring that clinical interventions are highly targeted, efficient, and successful.
研究概览
地位
尚未招聘
详细说明
This study integrates machine learning with a clinical trial framework to optimize the evaluation and management of Temporomandibular Disorders (TMD).
A total of 180 eligible participants are expected to be enrolled in the study.
To ensure a homogenous sample, strict screening will be conducted using standardized psychometric scales; patients with significant psychosocial confounders (defined as GAD-7 ≥10, PHQ-9 ≥15, PHQ-15 ≥10, or PSQI >5) or comorbidities such as fibromyalgia, rheumatic autoimmune diseases, and trauma history will be excluded.
Prior to treatment, baseline clinical examination, cone beam computed tomography (CBCT), and magnetic resonance imaging (MRI) data will be collected.
All clinical data and longitudinal pre- and post-treatment MRI findings will be utilized to train advanced multi-modal diagnostic models; based on this foundational intelligence, predictive algorithms will then be developed to determine the necessity of an MRI scan using only clinical data and CBCT images.
The enrolled participants will be divided by active maximum mouth opening into two subgroups (≤30 mm and >30 mm) and randomly assigned to three treatment arms: (1) Proprioceptive Training + Sham + LLLT (2 weeks of sham laser followed by 2 weeks of active laser acupuncture); (2) Proprioceptive Training + LLLT + LLLT (4 weeks of active laser acupuncture); and (3) Waiting List Control (receiving standard conservative care only).Proprioceptive training includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily.
LLLT targets the Xiaguan (ST7), Yifeng (SJ17), and bilateral Fengchi (GB20) points once weekly.
Assessments will be conducted biweekly during treatment, with final evaluation at 4 weeks and follow-ups at 1, 3, 6, 12, and 24 months post-treatment.
Post-treatment MRI will be performed at the 4-week endpoint to evaluate objective intra-articular and perimuscular soft-tissue changes, correlating with improvements in pain resolution efficiency and mandibular range of motion recovery.
研究类型
介入性
注册 (估计的)
180
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ting-Yu Huang, D.D.S.
- 电话号码：6835 +886 2-2672-3456
- 邮箱：tingyuh3012@gmail.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients diagnosed with temporomandibular disorders (TMDs) screened by the Department of Dentistry, Division of Oral and Maxillofacial Surgery at En Chu Kong Hospital, who have failed to respond to analgesic treatment for at least one week.
- Patients clinically examined and identified as having pain predominantly originating from muscles associated with mandibular movement.
- Patients aged between 18 and 70 years (inclusive) with full legal capacity.
- Patients who are willing to participate in the study and provide written informed consent.
Exclusion Criteria:
- Patients meeting any of the following clinical scale thresholds: Generalized Anxiety Disorder-7 (GAD-7)≥ 10, Patient Health Questionnaire-9 (PHQ-9) ≥ 15, Patient Health Questionnaire-15 (PHQ-15) ≥ 10, or Pittsburgh Sleep Quality Index (PSQI) > 5.
- Patients with tumors of the temporomandibular joint (TMJ) or head and neck region.
- Patients with acute or chronic infections.
- Patients with a history of neuropathy or stroke.
- Patients with a history of head and neck trauma.
- Patients diagnosed with fibromyalgia.
- Patients diagnosed with autoimmune or rheumatic diseases.
- Patients diagnosed with irritable bowel syndrome (IBS).
- Patients with claustrophobia (unable to undergo MRI examination).
- Women who are pregnant or lactating, or parents currently in the infant care/nursing period.
- Patients who have received invasive treatment for temporomandibular joint disorders within the past 3 months.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Proprioceptive Training + Sham + LLLT
Participants in this group will receive proprioceptive training combined with low-level laser acupuncture.
For the first 2 weeks, sham laser acupuncture (identical visual and auditory cues with no energy output) will be administered, followed by 2 weeks of active laser acupuncture.
Proprioceptive training will be performed three times daily throughout the 4-week period.
|
Laser acupuncture targets the Xiaguan (ST7), Yifeng (SJ17), and bilateral Fengchi (GB20) points once weekly.
For the LLLT+LLLT group, active laser is given for 4 weeks.
For the Sham+LLLT group, sham laser is given for the first 2 weeks followed by 2 weeks of active laser.
其他名称：
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
其他名称：
|
|
实验性的：Proprioceptive Training + LLLT + LLLT
Participants in this group will receive proprioceptive training combined with 4 weeks of active low-level laser acupuncture.
Proprioceptive training will be performed three times daily, and active laser acupuncture will be administered once weekly for the entire 4-week period.
|
Laser acupuncture targets the Xiaguan (ST7), Yifeng (SJ17), and bilateral Fengchi (GB20) points once weekly.
For the LLLT+LLLT group, active laser is given for 4 weeks.
For the Sham+LLLT group, sham laser is given for the first 2 weeks followed by 2 weeks of active laser.
其他名称：
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
其他名称：
|
|
有源比较器：Waiting List Control
Participants assigned to this group will serve as a waiting list control and will receive standard conservative care, specifically utilizing a stabilization splint, during the 4-week trial period.
They will not receive the experimental proprioceptive training or laser acupuncture protocols during this phase.
|
Standard conservative clinical care utilizing a hard acrylic flat-plane stabilization splint (centric stabilization splint) for TMD management.
The splint is customized to provide even, bilateral occlusal contact in the musculoskeletal stable position during the 4-week trial period.
其他名称：
|
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 |
|---|---|---|
|
Tenderness of Masticatory Muscles and Periarticular Temporomandibular Joint Pain
大体时间：Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
|
Evaluated using the Numeric Rating Scale (NRS) 0-10, to measure pain intensity upon palpation of the masticatory muscles and the periarticular structures of the temporomandibular joint.
|
Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
|
|
Pain-Free Mandibular Active Range of Motion
大体时间：Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
|
Measured as the maximum active mouth opening (maximum unassisted pain-free opening) in millimeters using a calibrated ruler.
|
Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
|
|
Jaw Functional Limitation Scale - 20 (JFLS-20)
大体时间：Baseline, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
|
The Jaw Functional Limitation Scale-20 (JFLS-20) is a 20-item patient-reported questionnaire assessing jaw functional limitation during the previous month.
Each item is rated from 0 (no limitation) to 10 (severe limitation).
Domain scores are calculated as the mean of completed items for mastication (items 1-6), vertical jaw mobility (items 7-10), and verbal and non-verbal communication (items 11-20).
The overall JFLS-20 score is the mean of the three domain scores.
Scores range from 0 to 10; higher scores indicate greater jaw functional limitation and a worse outcome.
A domain score is calculated when no more than 2 mastication items, 1 mobility item, or 2 communication items are missing.
|
Baseline, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cervical active range of motion (AROM) limitation
大体时间：Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
|
Cervical AROM of flexion, extension, left/right rotation, and left/right lateral flexion is measured using a plastic universal goniometer in degrees from 0-80/40/45 etc.
For reporting purposes, each movement is categorized as "normal", "limited", or "no movement", based on predefined cutoffs (e.g., rotation ≥80° = normal; 40-79° = limited; <40° = no movement).
The outcome is the proportion of participants with limited cervical AROM at each time point.
|
Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
|
|
MRI T2-Weighted Soft Tissue Assessment
大体时间：Baseline (pre-treatment) and 4 weeks (post-treatment endpoint).
|
T2-weighted MRI scans were compared with T1-weighted images to identify joint effusion, disc displacement, perimuscular/intramuscular edema, and muscle hemorrhage.
|
Baseline (pre-treatment) and 4 weeks (post-treatment endpoint).
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence, Severity, and Frequency of Treatment-Emergent Adverse Events Through 4 Weeks
大体时间：2 weeks and 4 weeks (endpoint)
|
The occurrence, type, severity, and frequency of adverse events and treatment-related discomfort associated with proprioceptive training, laser acupuncture, or stabilization splint therapy will be recorded.
The number of participants experiencing at least one adverse event and the number of adverse events will be summarized by treatment group.
Adverse events will be assessed at 2 weeks and 4 weeks, including the 4-week endpoint.
|
2 weeks and 4 weeks (endpoint)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Ching-Po Lin, PhD、Institute of Neuroscience, Brain Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. Department of Education and Research, Taipei City Hospital, Taipei, Taiwan.
- 研究主任：Ching-Mao Chang, MD, PhD、Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. Institute of Traditional Medicine, and Schools of Chinese Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月5日
初级完成 (估计的)
2027年6月25日
研究完成 (估计的)
2027年7月31日
研究注册日期
首次提交
2026年8月13日
首先提交符合 QC 标准的
2026年8月13日
首次发布 (实际的)
2026年8月18日
研究记录更新
最后更新发布 (实际的)
2026年8月20日
上次提交的符合 QC 标准的更新
2026年8月18日
最后验证
2026年8月1日
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
- ECKIRB1141206
- NSTC1152635B385001 (其他赠款/资助编号：National Science and Technology Council)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared to protect patient privacy and comply with the institutional review board (IRB) regulations
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.