Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders
2026年8月18日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
180
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ting-Yu Huang, D.D.S.
- 電話番号：6835 +886 2-2672-3456
- メール：tingyuh3012@gmail.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
他の名前：
|
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実験的：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.
他の名前：
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
他の名前：
|
|
アクティブコンパレータ：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tenderness of Masticatory Muscles and Periarticular Temporomandibular Joint Pain
時間枠：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.
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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
時間枠：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.
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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)
時間枠：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.
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Baseline, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cervical active range of motion (AROM) limitation
時間枠：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.
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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
時間枠：Baseline (pre-treatment) and 4 weeks (post-treatment endpoint).
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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).
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence, Severity, and Frequency of Treatment-Emergent Adverse Events Through 4 Weeks
時間枠：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)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：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.
- スタディディレクター：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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月5日
一次修了 (推定)
2027年6月25日
研究の完了 (推定)
2027年7月31日
試験登録日
最初に提出
2026年8月13日
QC基準を満たした最初の提出物
2026年8月13日
最初の投稿 (実際)
2026年8月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月20日
QC基準を満たした最後の更新が送信されました
2026年8月18日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ECKIRB1141206
- NSTC1152635B385001 (その他の助成金/資金番号：National Science and Technology Council)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared to protect patient privacy and comply with the institutional review board (IRB) regulations
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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