Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders

NCT07771296 | Not Yet Recruiting

• 2 other identifiers: ECKIRB1141206NSTC1152635B385001
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Temporomandibular Disorders (TMD); TMJ Disorder; TMJ Pain

Keywords

Machine Learning; Cone-Beam Computed Tomography; CBCT; Magnetic Resonance Imaging; MRI; Proprioceptive Training; low level laser; Laser Acupuncture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Cervical active range of motion (AROM) limitation

  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

  Baseline (pre-treatment) and 4 weeks (post-treatment endpoint).

Other Outcomes (1)

• Incidence, Severity, and Frequency of Treatment-Emergent Adverse Events Through 4 Weeks

  2 weeks and 4 weeks (endpoint)

Study Arms (3)

Proprioceptive Training + Sham + LLLT

EXPERIMENTAL

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; Behavioral: Proprioceptive Training

Proprioceptive Training + LLLT + LLLT

EXPERIMENTAL

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; Behavioral: Proprioceptive Training

Waiting List Control

ACTIVE COMPARATOR

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

Interventions

Low-Level Laser Acupuncture DEVICE

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.

Also known as: Low-Level Laser, Laser Acupuncture

Proprioceptive Training + LLLT + LLLT; Proprioceptive Training + Sham + LLLT

Proprioceptive Training BEHAVIORAL

Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.

Also known as: Motor Control Training, Cranio-Cervico-Mandibular Malalignment / Dysfunction Training, Sensorimotor Training, Trigemino-Cervical System Rehabilitation

Proprioceptive Training + LLLT + LLLT; Proprioceptive Training + Sham + LLLT

Stabilization Splint Treatment DEVICE

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.

Also known as: occlusal splint

Waiting List Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• En Chu Kong Hospital: lead
• National Yang Ming Chiao Tung University: collaborator

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy; Occlusal Splints

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• 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 DIRECTOR

Central Study Contacts

Ting-Yu Huang, D.D.S.

CONTACT

+886 2-2672-3456; tingyuh3012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind trial using coded laser devices (e.g., Device A and Device B) provided by the manufacturer. Both devices have identical appearances and sounds. The investigator, who acts as the care provider and outcomes assessor, knows the group assignment but remains blind to which code represents the active laser energy until the database is locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share