UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059916 |
|---|---|
| Receipt number | R000068474 |
| Scientific Title | Noninvasive Estimation of Temporomandibular Disorders and Masticatory Myofascial Pain Using Commercial Smart Devices |
| Date of disclosure of the study information | 2025/11/28 |
| Last modified on | 2025/11/28 23:21:49 |
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Basic information
Public title
Study on Simple Jaw Movement and Pain Screening Using Smartphone and Earbuds
Acronym
Jaw Self-Check Study
Scientific Title
Noninvasive Estimation of Temporomandibular Disorders and Masticatory Myofascial Pain Using Commercial Smart Devices
Scientific Title:Acronym
Smart Device-Based Estimation of TMD and MMP
Region
| Japan |
Condition
Condition
Temporomandibular Disorders(TMD),Headache Attributed to TMD,Chronic Headache,
Orofacial PainMyofascial Pain
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether the differences in mandibular movement between the presence and absence of pain can be noninvasively estimated in patients with temporomandibular disorders and masticatory myofascial pain by measuring jaw motion using commercial smart devices (AirPods Pro and iPhone).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Angular velocity and acceleration of the mandible during jaw movement measured by the IMU sensors of AirPods Pro
*Timepoints:At initial visit and at the time of pain improvement
Key secondary outcomes
1. Mandibular motion trajectory captured via facial motion tracking (TrueDepth camera)
2. Pain score using the Numerical Rating Scale (NRS)
3. Maximum mouth opening (mm)
4. Presence of temporomandibular joint sounds (clicking or crepitus)
5. MPIC-J (Multidimensional Pain Inventory for Chronic Pain - Japanese version) scores
6. Clinical findings from muscle palpation of the masticatory muscles
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will wear AirPods Pro (equipped with IMU sensors) and perform 10 repetitions each of mouth opening and protrusive jaw movements while simultaneously being recorded by an iPhone TrueDepth camera. These measurements will be performed at two time points: (1) initial visit (with pain), and (2) after clinical pain improvement. Each session takes approximately 10 minutes. No drugs or invasive procedures are involved.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older who visit the Department of Dentistry and Oral Surgery at Keio University Hospital and are diagnosed with temporomandibular disorders or masticatory myofascial pain during clinical evaluation.
Key exclusion criteria
Individuals with a history of temporomandibular joint surgery
Individuals with cognitive impairment that hinders understanding and participation in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Usuda |
Organization
Keio University School of Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
160-8582
Address
Department of Oral and Maxillofacial Surgery, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
08066829372
shousuda@keio.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Usuda |
Organization
Keio University School of Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
160-8582
Address
Department of Oral and Maxillofacial Surgery, Keio University School of Medicine, 35 Shinanomachi, S
TEL
+81-3-5363-3826
Homepage URL
shousuda@keio.jp
Sponsor or person
Institute
Keio University School
Institute
Department
Personal name
Sho Usuda
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
0333531211
info-tr@ctr.hosp.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068474
