Marine Lipids Ease Painful TMD

You may be eligible if

• Inclusion
• Pre-screening (before Visit 0):
• Age ≥18 years.
• Pain in jaws, temples, ears, or in front of ears at least 5 days in the past 30 days, occurring monthly over the last 3 months.
• Pain not due to toothache or ear infection.
• Pain intensity ≥30 on a 0-100 numeric rating scale (NRS) during the week before pre-screening.
• Willing to provide written informed consent and follow all study procedures.
• Able to be contacted reliably during the study period.
• Visit 0 - Screening/Baseline:
• Meets all pre-screening criteria above.
• Examiner-confirmed TMD diagnosis (myalgia or arthralgia) per DC-TMD criteria.
• Discontinues omega-3 supplements prior to randomization and agrees not to use them during the study.
• Will not initiate new occlusal splint therapy during the study. Participants already using a splint ≥30 days prior may continue.
• Maintains stable facial pain management regimen:
• No changes to regularly scheduled daily pain medications.
• No initiation of new facial pain treatments (pharmacologic, injectable, or non-pharmacologic).
• Episodic prescription pain medications discontinued prior to randomization, except NSAIDs, acetaminophen, or low-dose aspirin.
• Visit 1 - Randomization:
• Completes ≥4 of 7 daily symptom diary (DSD) entries before Visit 1.
• Average weekly pain ≥30 on 0-100 NRS, or ≥30 on at least 4 days that week.
• Exclusion (Assessed at pre-screening and/or Visit 0):
• Allergy or hypersensitivity to fish or seafood.
• Botulinum toxin injections for facial pain within past 3 months.
• Facial trauma or orofacial surgery within past 6 weeks.
• History of renal failure or dialysis.
• History of hyperthyroidism.
• Immunocompromised state or autoimmune disorder.
• History of seizure disorder or uncontrolled seizures.
• Use of opioid medications in the past 30 days.
• Pregnancy.