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A Randomized Controlled Clinical Trial to Evaluate the Effectiveness, Safety, and Economics of TMJ Balancing Therapy for Temporomandibular Joint Disorder

A Randomized Controlled Clinical Trial to Evaluate the Effectiveness, Safety, and Economics of TBT for Temporomandibular Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010382
Enrollment
30
Registered
2025-04-03
Start date
2025-02-11
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : Temporomandibular joint balance therapy (TBT) for temporomandibular joint disorders (TMD). - TBT treatment is conducted through the following 3-step process. 1. Identifying the Balance Point

Sponsors

Daejeon University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women aged 19 to 70 years. 2) Individuals who report intermittent pain in the temporomandibular joint (unilateral or bilateral) lasting for more than 3 months based on the DT/TMD criteria. 3) Individuals whose pain in the temporomandibular joint (based on the side with the most severe pain for patients with bilateral pain) has an average Visual Analog Scale (VAS) score of 40 mm or higher over the past week. 4) Individuals with localized pain in the temporomandibular joint and surrounding areas (temple, inside the ear, or in front of the ear) associated with jaw movement, function, or related activities. 5) Individuals whose pain is confirmed by the examiner through palpation in the temporalis muscle, masseter muscle, or the lateral pole of the mandibular joint's articular prominence, corresponding to one of the following types: myalgia, myofascial pain, or arthralgia; or individuals with headaches located in the temporalis area that are reproducible during examination and are triggered or worsened by jaw movement.

Exclusion criteria

Exclusion criteria: 1) Individuals who have undergone temporomandibular joint-related surgeries, such as orthognathic surgery. 2) Individuals with multiple pain disorders (e.g., rheumatoid arthritis) or neurological conditions (e.g., brain tumor, stroke, trigeminal neuralgia) that could interfere with the interpretation of treatment effects or outcomes. 3) Individuals currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that could affect study results. 4) Individuals who have started or discontinued medications affecting pain, such as nonsteroidal anti-inflammatory drugs, within the past month. 5) Individuals deemed unsuitable for participation by the investigator (e.g., those with implanted electrical devices or pacemakers, or those showing clear signs of rheumatoid arthritis upon joint involvement assessment). 6) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Average temporomandibular joint pain VAS(100 mm) over the past week

Secondary

MeasureTime frame
Average temporomandibular joint pain VAS(100 mm) over the past week;Worst temporomandibular joint pain VAS(100 mm) in the past week;Vertical temporomandibular joint opening (Pain free opening);Vertical temporomandibular joint opening (Maximum unassisted opening);Jaw Functional Limitation Scale (JFLS-8);DC/TMD The Graded Chronic Pain Scale (GCPS 2.0);Treatment Expectancy Scale;Patient Global Impression of Change (PGIC);Quality-adjusted life years (QALYs);Euroqol five-dimension scale (EQ-5D);Euroqol visual analog scale (EQ-VAS);Medical costs (formal and informal medical costs), lost productivity costs (morbidity costs);Incremental cost-effectiveness ratio(ICER, cost per QALYs)

Countries

Korea, Republic of

Contacts

Public ContactMiso Park

Daejeon Korean Medicine Hospital of Daejeon University

miso.sophia.park@gmail.com+82-42-470-9541

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 23, 2026