None listed
Conditions
Interventions
Medical Device : 1. Intervention Group (ClickSound, Ver 2.0.1 Applied Group)
Intervention Overview
Treatment of temporomandibular disorder (K07.6) using the ClickSound, Ver 2.0.1 application
Trainin
Sponsors
DiWAVE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 15 years or older 2. Individuals diagnosed with temporomandibular disorder (K07.6) 3. Individuals with a visual analogue scale (VAS) pain score of 40 or higher during maximum mouth opening 4. Individuals who have experienced pain during function (chewing, mouth opening) for at least the past two weeks prior to screening 5. Individuals with adequate vision and hearing to participate in the clinical trial 6. Individuals who have no difficulty using a mobile application on a smartphone 7. Individuals who own a personal smartphone 8. Individuals who have no difficulty reading and writing in Korean 9. Individuals who have received a full explanation of this clinical trial, understand its contents, voluntarily decide to participate, and provide written consent to comply with the study guidelines
Exclusion criteria
Exclusion criteria: 1. Individuals diagnosed with temporomandibular disorder (K07.6) but showing bony changes on radiological examination [TMJ (temporomandibular joint) panorama]. 2. Individuals with metabolic arthritis or temporomandibular joint arthritis, including suppurative or tuberculous arthritis, or those with other systemic infections. 3. Individuals scheduled to undergo surgery requiring general anesthesia during the trial. However, if the planned surgery only requires local anesthesia and can be performed as a day case without hospitalization, exclusion is not necessary if, in the investigator’s opinion, the procedure does not compromise the participant's safety or interfere with the trial procedures. 4. Individuals who have participated in any type (online or offline) of temporomandibular joint-related clinical trial within 12 months prior to the study enrollment date. 5. Individuals deemed unsuitable for this study based on the investigator’s judgment for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain score (100mm Visual Analogue Scale, VAS) during maximum mouth opening at week 6 compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Visual Analogue Scale (VAS) score during maximum mouth opening at 2 and 4 weeks compared to baseline.;Change in pressure pain threshold (PPT) at the most tender point at 2, 4, and 6 weeks compared to baseline.;Change in maximum mouth opening at 2, 4, and 6 weeks compared to baseline.;Change in Patient Health Questionnaire-9 (PHQ-9) score at 2, 4, and 6 weeks compared to baseline;Change in the amount of rescue medication use at 2, 4, and 6 weeks compared to baseline.;Change in the frequency of rescue medication use at 2, 4, and 6 weeks compared to baseline. | — |
Countries
Korea, Republic of
Contacts
Public ContactSeong Taek Kim
Yonsei University Health System, Dental Hospital
Outcome results
None listed