Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEn Chu Kong Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Low-Level Laser Acupuncture
DeviceLaser 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.
Proprioceptive Training
BehavioralIncludes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
Stabilization Splint Treatment
DeviceStandard 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.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Proprioceptive Training + Sham + LLLTExperimental treatment 2 interventions
Group B: Proprioceptive Training + LLLT + LLLTExperimental treatment 2 interventions
Group C: Waiting List ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Tenderness of Masticatory Muscles and Periarticular Temporomandibular Joint Pain
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.
Time frame
Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.2
Pain-Free Mandibular Active Range of Motion
Measured as the maximum active mouth opening (maximum unassisted pain-free opening) in millimeters using a calibrated ruler.
Time frame
Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.3
Jaw Functional Limitation Scale - 20 (JFLS-20)
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.
Time frame
Baseline, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.Secondary outcomes
1
Cervical active range of motion (AROM) limitation
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.
Time frame
Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.2
MRI T2-Weighted Soft Tissue Assessment
T2-weighted MRI scans were compared with T1-weighted images to identify joint effusion, disc displacement, perimuscular/intramuscular edema, and muscle hemorrhage.
Time frame
Baseline (pre-treatment) and 4 weeks (post-treatment endpoint).Other outcomes
1
Incidence, Severity, and Frequency of Treatment-Emergent Adverse Events Through 4 Weeks
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.
Time frame
2 weeks and 4 weeks (endpoint)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
En Chu Kong Hospital
Lead sponsor
National Yang Ming Chiao Tung University
Collaborator
Source ClinicalTrials.gov