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Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders

18 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

180

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.
Inne nazwy:
  • Low-Level Laser
  • Laser Acupuncture
Behawioralne: Proprioceptive Training
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
Inne nazwy:
  • Motor Control Training
  • Cranio-Cervico-Mandibular Malalignment / Dysfunction Training
  • Sensorimotor Training
  • Trigemino-Cervical System Rehabilitation
Eksperymentalny: 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.
Urządzenie: 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.
Inne nazwy:
  • Low-Level Laser
  • Laser Acupuncture
Behawioralne: Proprioceptive Training
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
Inne nazwy:
  • Motor Control Training
  • Cranio-Cervico-Mandibular Malalignment / Dysfunction Training
  • Sensorimotor Training
  • Trigemino-Cervical System Rehabilitation
Aktywny komparator: 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.
Urządzenie: 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.
Inne nazwy:
  • szyna okluzyjna

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Tenderness of Masticatory Muscles and Periarticular Temporomandibular Joint Pain
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Cervical active range of motion (AROM) limitation
Ramy czasowe: 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
Ramy czasowe: 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).

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Incidence, Severity, and Frequency of Treatment-Emergent Adverse Events Through 4 Weeks
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

En Chu Kong Hospital

Współpracownicy

National Yang Ming Chiao Tung University

Śledczy

  • Dyrektor Studium: 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.
  • Dyrektor Studium: 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.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

5 października 2026

Zakończenie podstawowe (Szacowany)

25 czerwca 2027

Ukończenie studiów (Szacowany)

31 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

13 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

18 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ECKIRB1141206
  • NSTC1152635B385001 (Inny numer grantu/finansowania: National Science and Technology Council)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be shared to protect patient privacy and comply with the institutional review board (IRB) regulations

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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