Omega-3 supplement with special anti-inflammatory ingredients for chronic TMD pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ADAPT study is a 100-participant, randomized, quadruple-masked trial at a single site that investigates an omega-3 supplement enriched with specialized pro-resolving mediator precursors for adults with chronic TMD pain. Participants are randomly assigned to receive either the active supplement or a matched placebo daily for 8 weeks, with masking maintained for participants, clinicians, and outcomes assessors. The study measures changes in facial pain intensity, pressure pain sensitivity at jaw and other sites, and impacts on daily activities, sleep, mood, and quality of life, along with optional blood analysis. Data are collected through daily pain diaries, mid-study and final assessments, and a follow-up safety call. The trial will inform whether this lipid-based intervention can provide meaningful relief or pain modulation in TMD.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Anne E Sanders, PhD — University of North Carolina, Chapel Hill
• Study coordinator: Anne E Sanders, PhD
• Email: adaptsms@adapt.study
• Phone: (919) 246-5833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.