| NCT ID | NCT07437313 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Temporomandibular Disorder (TMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-09-25 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-09-25 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Anne E Sanders, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT07437313 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Temporomandibular Disorder (TMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07437313 currently recruiting?
Yes, NCT07437313 is actively recruiting participants. Contact the research team at adaptsms@adapt.study for enrollment information.
Where is the NCT07437313 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07437313 clinical trial?
NCT07437313 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Anne E Sanders, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 100 participants.