None listed
Conditions
Interventions
Medical Device : Study Group: DTx app (Clickless DTx), 6 weeks
Control Group: Sham app, 6 weeks
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(with conventional cl
Sponsors
Beyondmedicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 to 65 years old. 2) Individuals diagnosed with temporomandibular joint disorders such as muscle-related dysfunction, internal derangement, or temporomandibular arthritis through clinical and radiological examinations 3) Individuals who voluntarily decide to participate in this clinical trial and provide written consent.
Exclusion criteria
Exclusion criteria: 1.Structural disorders of the temporomandibular joint: Ankylosis, tumors. 2.Traumatic disorders of the temporomandibular joint: Mandibular Condylar Fracture, severe trauma to the maxillofacial region (e.g., from motor vehicle accidents, assault). 3.Individuals with rare muscular disorders such as Myasthenia gravis, Eaton-Lambert syndrome, and Amyotrophic lateral sclerosis 4.Individuals with severe hypertension, diabetes, or other metabolic disorders. 5.Individuals diagnosed with neurological disorders (such as Parkinson's disease, Alzheimer's disease) or psychiatric disorders. 6.Individuals currently taking medications for sleep disorders (e.g., benzodiazepines, neuroleptic, tricyclic antidepressants) or potentially using medications not previously agreed upon, alcohol, or narcotics. 7.Individuals undergoing orthodontic treatment or wearing other intraoral devices (except for Occlusion stabilization splint)). 8.Individuals who have participated in another clinical trial within the past 4 weeks prior to screening. 9.Pregnant women or individuals planning pregnancy during the clinical trial period. 10. Any other individuals deemed unsuitable for participation in this clinical trial by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain scores (100mm VAS) measured during Maximum Mouth opening (MMO) assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pain scores (100mm VAS) measured during Maximum Mouth opening (MMO) assessment.;Change in maximal mouth opening (MMO) values.;Change in Jaw Functional Limitation Scale(JFLS-20) values.;Change in Oral Behavior Checklist(OBC) values.;Change in Patient Health Questionnaire-4(PHQ-4) values.;App satisfaction score (applicable only to the experimental group);compliance (applicable only to the experimental group);Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactSoyoung Jung
Hallym University Medical Center
Outcome results
None listed