NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Marine Lipids Ease Painful TMD

Not Yet RecruitingNA

Sponsor: University of North Carolina, Chapel Hill

Conditions: Temporomandibular Disorder (TMD)

Interventions: SPM Precursor-Enriched Marine Lipid Supplement, Medium-Chain Triglyceride Supplement

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Chapel Hill, North Carolina, United States