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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Ting-Yu Huang, D.D.S.
- Telefonnummer: 6835 +886 2-2672-3456
- E-Mail: tingyuh3012@gmail.com
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
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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.
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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.
Andere Namen:
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
Andere Namen:
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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.
|
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.
Andere Namen:
Includes gentle teeth tapping, tongue-to-palate contact, and neutral head-neck posture exercises, performed three times daily for 4 weeks.
Andere Namen:
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Aktiver 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.
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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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Tenderness of Masticatory Muscles and Periarticular Temporomandibular Joint Pain
Zeitfenster: 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.
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Pain-Free Mandibular Active Range of Motion
Zeitfenster: Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
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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.
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Jaw Functional Limitation Scale - 20 (JFLS-20)
Zeitfenster: Baseline, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
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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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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cervical active range of motion (AROM) limitation
Zeitfenster: Baseline, 2 weeks, 4 weeks (endpoint), and long-term follow-ups at 1, 3, 6, 12, and 24 months.
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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
Zeitfenster: 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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Andere Ergebnismessungen
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence, Severity, and Frequency of Treatment-Emergent Adverse Events Through 4 Weeks
Zeitfenster: 2 weeks and 4 weeks (endpoint)
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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.
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2 weeks and 4 weeks (endpoint)
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Ermittler
Ermittler
- Studienleiter: 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.
- Studienleiter: 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Bewegungsapparates
- Stomatognathe Erkrankungen
- Muskelerkrankungen
- Gelenkerkrankungen
- Kiefererkrankungen
- Unterkiefererkrankungen
- Kraniomandibuläre Erkrankungen
- Erkrankungen des Kiefergelenks
- Therapeutika
- Orthopädische Ausrüstung
- Chirurgische Ausrüstung
- Ausrüstung und Vorräte
- Lasertherapie
- Phototherapie
- Orthotische Geräte
- Low-Level-Lichttherapie
- Okklusalschienen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- ECKIRB1141206
- NSTC1152635B385001 (Andere Zuschuss-/Finanzierungsnummer: National Science and Technology Council)
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Beschreibung des IPD-Plans
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