Temporomandibular Disorders
Conditions
Interventions
In patients with temporomandibular disorders, esflurbiprofen with peppermint oil LOQOA Tape will be applied topically to the skin over the temporomandibular joint region.
Sponsors
ITO NANAKO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Target disease Patients with temporomandibular disorders. 2 Severity of symptoms Pain during mastication must be 40 mm or more on a 100 mm visual analog scale. 3 Jaw movement function Maximum mouth opening must be between 35 mm and 50 mm. 4 Duration of symptoms and prior treatment Symptoms must continue for several weeks or more. No treatment for temporomandibular disorders before enrollment. 5 Suitability for patch application Normal skin at the application site. No allergy to the patch components. 6 Age and sex Age 18 years or older. Both sexes allowed. 7 Ability to consent and follow procedures Patients must give written informed consent. Patients must follow study procedures.
Exclusion criteria
Exclusion criteria: 1. Participants with a history of or current skin conditions at the planned application site (preauricular area corresponding to the temporomandibular joint), including rash, erosion, ulceration, eczema, contact dermatitis, or photosensitivity. 2. Participants with a history of hypersensitivity or allergic reactions to esflurbiprofen with peppermint oil, adhesives, or other non-steroidal anti-inflammatory drugs (NSAIDs), regardless of the route of administration (topical or oral). 3. Participants who meet any of the contraindications listed in the latest package insert of the investigational product, including peptic ulcer disease, severe hematologic disorders, severe hepatic dysfunction, severe renal dysfunction, severe cardiac failure, severe hypertension, a history of hypersensitivity to any component of the investigational product or to flurbiprofen, aspirin-induced asthma or a history thereof, or current treatment with enoxacin hydrate, lomefloxacin, norfloxacin, or prulifloxacin. 4. Pregnant or breastfeeding women. 5. Participants with psychiatric disorders, cognitive impairment, severe depressive symptoms, or severe anxiety disorders that may interfere with the ability to perform subjective assessments such as the Visual Analog Scale (VAS) or quality of life questionnaires, or with adherence to the study procedures (patch application and diary completion). 6. Participants with structural diseases of the temporomandibular joint, such as temporomandibular joint dislocation or tumors. 7. Participants who have received intra-articular temporomandibular joint injections (for example, hyaluronic acid or steroids), botulinum toxin injections, or surgical treatment within 30 days prior to enrollment. 8. Participants who have initiated new physical therapy, splint therapy, or acupuncture within 14 days prior to enrollment. 9. Participants who have used other NSAIDs (oral, topical, or suppository formulations) or topical analgesics within 7 days prior to enrollment, or who are currently participating in another clinical study. 10. Participants deemed inappropriate by the principal investigator or overall study coordinator based on considerations of safety or data reliability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in temporomandibular joint pain VAS score during mastication [Difference between baseline (Day 1) and end of treatment (Day 15)] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pain-free maximum mouth opening, Day 15 minus Day 1 Change in temporomandibular joint pain at rest (VAS), Day 15 minus Day 1 Change in oral health-related quality of life (OHIP-14), Day 15 minus Day 1 Patient Global Impression of Change (PGIC) score | — |
Contacts
Public ContactNANAKO ITO
Hiroshima University
Outcome results
None listed