None listed
Conditions
Interventions
Medical Device : A total patients with temporomandibular disorders were randomly allocated in a 1:1 ratio to a customized hard stabilization splint group or a ready-made soft splint group . The hard
Sponsors
Hallym University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Adults aged 19 years or older whose jawbone growth has been completed. b. Individuals with temporomandibular joint disorder caused by the masticatory muscles. c. Individuals who agree to participate in the clinical trial and have signed the informed consent form. non-probability sampling
Exclusion criteria
Exclusion criteria: a. Individuals whose pain is determined to be of dental origin b. Individuals judged to have skeletal temporomandibular disorders (TMD) c. Individuals with a history of temporomandibular joint-related trauma within the past 6 months d. Individuals with the loss of more than five teeth e. Individuals who use partial or complete dentures f. Individuals with systemic diseases affecting the joints g. Individuals with abnormal morphology of the mandibular condyle on X-ray imaging h. Individuals for whom participation in the clinical trial is deemed inappropriate for ethical reasons or because it may affect the clinical trial outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total modified Helkimo index score from baseline (T0) to each follow-up time point | — |
Secondary
| Measure | Time frame |
|---|---|
| Within-group change in total modified Helkimo index score (baseline to 4 weeks; baseline to 12 weeks);Between-group difference in total modified Helkimo index score and score change;Splint-related adverse events and tolerability | — |
Countries
Korea, Republic of
Contacts
Public ContactByoungeun Yang
Hallym University Medical Center
Outcome results
None listed