Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders

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.

Study Overview

• Status: Not yet recruiting
• Conditions: TMJ Disorder; Temporomandibular Disorders (TMD); TMJ Pain
• Intervention / Treatment: Device: Low-Level Laser Acupuncture; Behavioral: Proprioceptive Training; Device: Stabilization Splint Treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting-Yu Huang, D.D.S.; Phone Number: 6835 +886 2-2672-3456; Email: tingyuh3012@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Low-Level Laser Acupuncture; 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.; Other Names: Low-Level Laser; Laser Acupuncture; Behavioral: Proprioceptive Training; Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.; Other Names: Motor Control Training; Cranio-Cervico-Mandibular Malalignment / Dysfunction Training; Sensorimotor Training; Trigemino-Cervical System Rehabilitation
Experimental: 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.	Device: Low-Level Laser Acupuncture; 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.; Other Names: Low-Level Laser; Laser Acupuncture; Behavioral: Proprioceptive Training; Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.; Other Names: Motor Control Training; Cranio-Cervico-Mandibular Malalignment / Dysfunction Training; Sensorimotor Training; Trigemino-Cervical System Rehabilitation
Active Comparator: 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.	Device: Stabilization Splint Treatment; 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.; Other Names: occlusal splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks and 4 weeks (endpoint)

Collaborators and Investigators

• Sponsor: En Chu Kong Hospital
• Collaborators: National Yang Ming Chiao Tung University
• Investigators: Study Director: 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.; Study Director: 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: August 13, 2026
• First Submitted That Met QC Criteria: August 13, 2026
• First Posted (Actual): August 18, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: MRI; Cone-Beam Computed Tomography; Magnetic Resonance Imaging; CBCT; Machine Learning; Proprioceptive Training; low level laser; Laser Acupuncture
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Temporomandibular Joint Disorders; Therapeutics; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Laser Therapy; Phototherapy; Orthotic Devices; Low-Level Light Therapy; Occlusal Splints
• Other Study ID Numbers: ECKIRB1141206; NSTC1152635B385001 (Other Grant/Funding Number: National Science and Technology Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect patient privacy and comply with the institutional review board (IRB) regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No