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Marine Lipids Ease Painful TMD

Safety And Analgesic Efficacy of Marine Lipid Precursors of Specialized Pro-Resolving Mediators in Adults With Chronic Temporomandibular Pain

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks, 12 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants are randomized 1:1 to receive either the SPM precursor supplement or a matched placebo daily for 8 weeks."
  • "Participants will record their daily facial pain intensity in paper diaries, complete short questionnaires at baseline, Week 4, and Week 8, and undergo experimental pain testing with a handheld algometer at baseline, Week 4, and Week 8."
  • "Study Overview Participant Procedures Screening/Baseline (Visit 0-1): DC-TMD examination to confirm eligibility; review of medications and health history; baseline questionnaires; pressure pain threshold testing; body manikin pain mapping."
  • "Daily Diaries: Participants record facial pain intensity (0-100 NRS) each day for 8 weeks."
  • "Mid-study Assessment (Week 4, Visit 2): Questionnaires for pain, mood, quality of life; pressure pain threshold testing."
  • "Final Visit (Week 8, Visit 3): Repeat questionnaires, pressure pain testing, and body manikin assessments; blood collection for polyunsaturated fatty acid (PUFA)/oxylipin analysis."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether an omega-3 supplement with added ingredients helps reduce long-term jaw and face pain from TMD, a disorder of the jaw muscles or joint. It is for adults age 18 or older with TMD confirmed by an examiner. Participants take either the supplement or a placebo (a look-alike with no active study ingredient) daily for 8 weeks.

The ADAPT study is a single-site, Phase 2b, randomized, quadruple-masked, placebo-controlled trial evaluating an omega-3 dietary supplement enriched with specialized pro-resolving mediator (SPM) precursors in adults with chronic temporomandibular disorder (TMD) pain. The trial will enroll 100 adults aged 18 years or older with examiner-confirmed TMD myalgia or arthralgia will be enrolled at the University of North Carolina at Chapel Hill, Adams School of Dentistry. Participants are randomized 1:1 to receive either the SPM precursor supplement or a matched placebo daily for 8 weeks. Randomization is stratified by sex, and study agents are identical in appearance to maintain masking. The study aims to evaluate whether the SPM precursor supplement: Reduces facial pain intensity compared with placebo. Changes pressure pain sensitivity at the jaw and other standard body sites. Affects other aspects of chronic pain, including duration, interference with daily activities, headache burden, anxiety, depression, jaw-related quality of life, and overall patient-reported change. Participants will record their daily facial pain intensity in paper diaries, complete short questionnaires at baseline, Week 4, and Week 8, and undergo experimental pain testing with a handheld algometer at baseline, Week 4, and Week 8. Safety is monitored through the documentation of all adverse events throughout the study period.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, agree in writing to join, follow study steps, and be reachable during the study.
  • Have pain in the jaw, temples, ears, or in front of the ears on at least 5 days in the past 30 days, with pain each month for the past 3 months. Pain must not be from a toothache or ear infection.
  • Rate pain at least 30 out of 100 during the week before the first screening.
  • Have an examiner confirm TMD with pain in the jaw muscles or jaw joint.
  • Stop omega-3 supplements before being assigned a study treatment and avoid them during the study.
  • Do not start using a new jaw splint during the study. You may keep using one you started at least 30 days earlier.
  • Keep daily pain medicines unchanged and do not start new face pain treatments. Stop prescription pain medicines taken only as needed before treatment assignment, except NSAIDs (such as ibuprofen), acetaminophen, or low-dose aspirin.
  • Before treatment assignment, complete at least 4 of 7 daily pain diary entries. That week's pain must average at least 30 out of 100, or reach 30 on at least 4 days.

Who can't join

  • Allergy or sensitivity to fish or seafood.
  • Botulinum toxin injections for face pain in the past 3 months.
  • Face injury or surgery on the face or mouth in the past 6 weeks.
  • Past kidney failure or dialysis, a treatment that filters blood.
  • History of an overactive thyroid.
  • A weakened immune system or an autoimmune disease, in which the body attacks its own tissues.
  • History of a seizure disorder or seizures that are not controlled.
  • Use of opioid pain medicines in the past 30 days, or pregnancy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

NC