An interventional study of SPM Precursor-Enriched Marine Lipid Supplement and Medium-Chain Triglyceride Supplement in Temporomandibular Disorder (TMD), sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
Follow-up Call (1 week post-intervention): Safety check for adverse events.
Study Duration
Total participation: up to 12 weeks (pre-screening, 8-week intervention, 1-week follow-up).
Assessments at baseline, Week 4, Week 8, and follow-up call.
Population and Recruitment Adults ≥18 years with examiner-confirmed TMD myalgia or arthralgia. Participants of all races and ethnicities are eligible; anticipated demographics: \~77% female, 6% Hispanic, 83% White, 8% African American, 9% other.
Overall Goal To provide high-quality evidence on the effects of omega-3 SPM precursors on facial pain, pressure pain sensitivity, psychosocial distress, headache burden, jaw-related quality of life.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion
Pre-screening (before Visit 0):
Visit 0 - Screening/Baseline:
Visit 1 - Randomization:
Exclusion (Assessed at pre-screening and/or Visit 0):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental Arm - SPM Precursor Marine Lipid Supplement: Participants receive 2 g/day (1 g twice daily) of SPM Active® softgels containing 18-HEPE, 17-HDHA, and 14-HDHA. Softgels are identical in appearance to placebo. Duration: 8 weeks. Placebo Arm - Medium-Chain Triglyceride (MCT) Supplement: Participants receive 2 g/day (1 g twice daily) of MCT oil softgels, identical in appearance to active supplement. Duration: 8 weeks.
Dietary Supplement: SPM Precursor-Enriched Marine Lipid Supplement
Participants receive 2 grams per day of a placebo supplement, administered as medium-chain triglyceride (MCT) oil softgels. Participants take 1 gram orally twice daily for 8 weeks. The placebo softgels are identical in appearance and packaging to the active supplement. Participants remain in this arm for the full duration of the study.
Dietary Supplement: Medium-Chain Triglyceride Supplement
Participants receive omega-3 SPM precursor-enriched marine lipid softgels administered daily for 8 weeks at the dose specified in the protocol.
Participants receive matched placebo softgels daily for 8 weeks.
Change in average weekly facial pain intensity
Net change from baseline to Week 8 in average weekly facial pain intensity, calculated as the mean of daily entries recorded in the Daily Symptom Diary (DSD). Higher scores indicate worse pain.
Time frame: Baseline (week prior to randomization) through Week 8 (final visit, Day 56 ±7)
Rate of treatment-emergent adverse events
Rate of participants experiencing any adverse event (AE) that first appears or worsens after starting the study intervention and up to 7 days after the last dose. Investigators record onset, duration, severity, and relatedness to the study intervention. This measure evaluates the safety of the SPM precursor marine lipid supplement compared with placebo.
Time frame: From first dose (Visit 1/Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)
Change in TMD pain duration
Change from baseline to Week 8 (Visit 3) in the percentage of waking time with facial pain, expressed in percentage points, based on daily diary entries (0-100 scale).
Time frame: From Visit 1 (Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)
Change in TMD pain intensity and pain interference
Change from baseline to Week 8 (Visit 3) in TMD pain intensity (current, worst, and average) and interference with daily activities. Assessed using the Graded Chronic Pain Scale (0-10 scale), with higher scores indicating worse pain and greater interference.
Time frame: Visit 1 (Randomization, Day 0) to Visit 3 (Final visit, Day 56 ±7)
Change in headache impact
Change from baseline to Week 8 (Visit 3) in headache impact measured with the Headache Impact Test-6 (HIT-6). Scores range 36-78, with higher scores indicating greater headache-related impact.
Time frame: Visit 1 (Randomization, Day 0); Visit 2 (Mid-study visit, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)
Change in number of painful body sites
Change from baseline to Week 8 (Visit 3) in the number of anatomical locations marked as painful on anterior and posterior body manikins (range 0-42), with higher scores indicating more widespread pain.
Time frame: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in pressure pain thresholds
Change from baseline to Week 8 (Visit 3) in pressure pain thresholds (kg) measured bilaterally at five anatomical sites: temporalis, masseter, TM joint, trapezius, and lateral epicondyle. Up to 5 trials per site are performed until two measurements differ by ≤0.2 kg. Higher numbers indicate lower pain sensitivity.
Time frame: Visit 0 (Screening/Baseline, 7-21 days before Visit 1), Visit 3 (Final visit, Day 56 ±7)
Change in state anxiety
Change from Day 0 to Week 8 (Visit 3) in state anxiety measured using the State subscale of the State-Trait Anxiety Inventory (range 20-80), with higher scores indicating greater anxiety.
Time frame: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in depression
Change from Day 0 to Week 8 (Visit 3) in depressive symptoms measured using the Symptom Checklist-90 (SCL90) Depression subscale (range 0-48), with higher scores indicating more severe symptoms.
Time frame: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in TMD-related quality of life
Change from Day 0 to Week 8 (Visit 3) in the impact of TMD on daily activities, pain, psychological well-being, and other aspects of quality of life. Measured with a summary score using the Oral Health Impact Profile-TMD (OHIP-TMD, range 0-88), with higher scores indicating greater adverse impact.
Time frame: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in overall status
Change at Weeks 4 (Visit 2) and 8 (Visit 3) in participants' perceived change in activities, symptoms, emotions, and quality of life related to facial pain, assessed using the Patient Global Impression of Change questionnaire (7-point scale), with higher scores reflecting greater improvement.
Time frame: Visit 2 (Mid-study, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Time frame: beginning 9 and continuing for 36 months following publication
Access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Started Sep 2026 (actual). Primary completion is estimated for Jan 2030, 40 months after the start.
Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 40 months is above that.
Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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