Health TrialsbyHealthPanel

Marine Lipids Ease Painful TMD

ConditionTemporomandibular Disorder (TMD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Medium-Chain Triglyceride Supplement

    Dietary supplement

    Participants receive matched placebo softgels daily for 8 weeks.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SPM precursor marine lipid dietary supplementExperimental treatment 1 intervention
Group B: Medium-chain triglyceride dietary supplementPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Metagenics LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: