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What this study is

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.

What's being tested

  • SPM Precursor-Enriched Marine Lipid Supplement

    Intervention · DIETARY SUPPLEMENT

    Participants receive omega-3 SPM precursor-enriched marine lipid softgels administered daily for 8 weeks at the dose specified in the protocol.

  • Medium-Chain Triglyceride Supplement

    Intervention · DIETARY SUPPLEMENT

    Participants receive matched placebo softgels daily for 8 weeks.

Study details

Official title
Safety And Analgesic Efficacy of Marine Lipid Precursors of Specialized Pro-Resolving Mediators in Adults With Chronic Temporomandibular Pain
Sponsor
University of North Carolina, Chapel Hill
Conditions
Temporomandibular Disorder (TMD)
Enrolling
100 people
Starts
2026-09-25
Est. completion
2030-02
Design
Quadruple-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗