CompletedNot Applicable

Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial

South Korea82 participantsStarted 2019-10-17

Plain-language summary

This study is a 2-arm parallel, assessor blinded, multi-centre, randomised controlled trial.

Age range19 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients with unilateral or bilateral TMJ pain
✓. Patients with VAS≥40mm for the area showing TMJ pain (for patients with bilateral pain, the side with worse pain)
✓. Patients complaining of persistent of sporadic TMJ pain for at least 3 months
✓. Patients diagnosed as myofascial TMD (Axis I: Group 1) based on the RDC/TMD diagnostic criteria\[5\]
✓. Patients aged 19-70 years on the date they sign the consent form
✓. Patients who provide consent to participate in the trial and return the informed consent form

✕. Patients whose current pain episode developed or worsened because of a road traffic accident or traumatic injury
✕. Patients diagnosed in Group 2 or 3 of Axis I based on the RDC/TMD diagnostic criteria
✕. Patients who have undergone surgery related to the TMJ
✕. Patients with other chronic disease that could interfere with interpretation of the treatment effects or outcomes (e.g., rheumatoid arthritis, neoplastic disease, stroke, or myocardial infarction)
✕. Patients currently taking steroids, immunosuppressants, psychiatric drugs, or other drugs that could affect the study results
✕. Patients who have received HPP within the last month, or who have taken drugs that could affect pain, such as NSAIDs, within the last week
✕. Pregnant or breastfeeding women
✕. Patients who have finished participation in another clinical trial within the last month, who participated in another trial within 6 months of selection, or who are planning to participate in another clinical trial during the follow-up period

The difference in visual analogue scale (VAS) of temporomandibular pain

Timeframe: Week 6

NCT IDNCT04087005

SponsorJaseng Medical Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-21

Who can participate

Age range19 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients with unilateral or bilateral TMJ pain
✓. Patients with VAS≥40mm for the area showing TMJ pain (for patients with bilateral pain, the side with worse pain)
✓. Patients complaining of persistent of sporadic TMJ pain for at least 3 months
✓. Patients diagnosed as myofascial TMD (Axis I: Group 1) based on the RDC/TMD diagnostic criteria\[5\]
✓. Patients aged 19-70 years on the date they sign the consent form
✓. Patients who provide consent to participate in the trial and return the informed consent form

✕. Patients whose current pain episode developed or worsened because of a road traffic accident or traumatic injury
✕. Patients diagnosed in Group 2 or 3 of Axis I based on the RDC/TMD diagnostic criteria
✕. Patients who have undergone surgery related to the TMJ
✕. Patients with other chronic disease that could interfere with interpretation of the treatment effects or outcomes (e.g., rheumatoid arthritis, neoplastic disease, stroke, or myocardial infarction)
✕. Patients currently taking steroids, immunosuppressants, psychiatric drugs, or other drugs that could affect the study results
✕. Patients who have received HPP within the last month, or who have taken drugs that could affect pain, such as NSAIDs, within the last week
✕. Pregnant or breastfeeding women
✕. Patients who have finished participation in another clinical trial within the last month, who participated in another trial within 6 months of selection, or who are planning to participate in another clinical trial during the follow-up period