Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders
2026년 8월 18일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
180
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ting-Yu Huang, D.D.S.
- 전화번호: 6835 +886 2-2672-3456
- 이메일: tingyuh3012@gmail.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
다른 이름들:
|
|
활성 비교기: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Tenderness of Masticatory Muscles and Periarticular Temporomandibular Joint Pain
기간: 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
기간: 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)
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cervical active range of motion (AROM) limitation
기간: 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.
|
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MRI T2-Weighted Soft Tissue Assessment
기간: 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.
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Baseline (pre-treatment) and 4 weeks (post-treatment endpoint).
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence, Severity, and Frequency of Treatment-Emergent Adverse Events Through 4 Weeks
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: 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.
- 연구 책임자: 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 5일
기본 완료 (추정된)
2027년 6월 25일
연구 완료 (추정된)
2027년 7월 31일
연구 등록 날짜
최초 제출
2026년 8월 13일
QC 기준을 충족하는 최초 제출
2026년 8월 13일
처음 게시됨 (실제)
2026년 8월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 18일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ECKIRB1141206
- NSTC1152635B385001 (기타 보조금/기금 번호: National Science and Technology Council)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be shared to protect patient privacy and comply with the institutional review board (IRB) regulations
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .