Marine Lipids Ease Painful TMD

NCT07437313 | Not Yet Recruiting

• 1 other identifier: 25-0878
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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 electronic 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.

Conditions

Temporomandibular Disorder (TMD)

Keywords

Chronic facial pain; Temporomandibular joint pain; TMD myalgia; TMD arthralgia; Orofacial pain; Specialized pro-resolving mediators (SPMs); Omega-3 fatty acids; Marine lipid supplement; Dietary supplement intervention; Pressure pain sensitivity; Experimental pain testing; Central sensitization; Chronic pain mechanisms; Randomized controlled trial; Pain interference; Headache impact; Anxiety and depression in chronic pain; Quality of life; Migraine; Body pain distribution

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From first dose (Visit 1/Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)

Secondary Outcomes (9)

• Change in TMD pain duration

  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

  Visit 1 (Randomization, Day 0) to Visit 3 (Final visit, Day 56 ±7)

• Change in headache impact

  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

  Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)

• Change in pressure pain thresholds

  Visit 0 (Screening/Baseline, 7-21 days before Visit 1), Visit 3 (Final visit, Day 56 ±7)

Study Arms (2)

SPM precursor marine lipid dietary supplement

EXPERIMENTAL

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

Medium-chain triglyceride dietary supplement

PLACEBO COMPARATOR

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

Interventions

SPM Precursor-Enriched Marine Lipid Supplement DIETARY_SUPPLEMENT

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

SPM precursor marine lipid dietary supplement

Medium-Chain Triglyceride Supplement DIETARY_SUPPLEMENT

Participants receive matched placebo softgels daily for 8 weeks.

Medium-chain triglyceride dietary supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Metagenics, Inc.: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain; Anxiety Disorders; Migraine Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anne E Sanders, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne E Sanders, PhD

CONTACT

919-537-3275; anne_sanders@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcomes assessors are unaware of group assignment. Active and placebo softgels are identical in appearance and packaging. Randomization codes are maintained by an independent data manager until study completion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-site, Phase 2b, randomized, quadruple-masked (Participant, Care Provider, Investigator, Outcomes Assessor), placebo-controlled trial with parallel assignment. Participants are randomized 1:1 to receive either an omega-3 SPM precursor-enriched marine lipid dietary supplement or a matched placebo dietary supplement. Randomization is stratified by sex to ensure balance across arms. Study agents are administered daily for 8 weeks. The primary outcome is daily facial pain intensity recorded via electronic symptom diaries; secondary outcomes include self-administered questionnaires and pressure pain thresholds measured using a handheld algometer.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)