Marine Lipids Ease Painful TMD

NCT ID
NCT07437313
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University of North Carolina, Chapel Hill
Conditions
Temporomandibular Disorder (TMD)

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 100 participants (Estimated).

What is being studied

  • Dietary supplement: Medium-Chain Triglyceride Supplement
  • Dietary supplement: SPM Precursor-Enriched Marine Lipid Supplement

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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 locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • North Carolina, United States: 1

Sample of listed locations

  • University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, 27599, United States — Site recruitment status not specified in the registry data

Study details

Start date
September 25, 2026
Primary completion date
January 1, 2030
Completion date
February 1, 2030
First posted
February 27, 2026
Collaborators
Metagenics LLC, National Institute of Dental and Craniofacial Research (NIDCR)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07437313
Registry last updated
August 31, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07437313 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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