Temporomandibular Disorder (TMD)ADAPTNCT07437313
Marine Lipids Ease Painful TMD
A study testing SPM Precursor-Enriched Marine Lipid Supplement and Medium-Chain Triglyceride Supplement in people with Temporomandibular Disorder (TMD), run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorder (TMD)
- What is being tested?
- SPM Precursor-Enriched Marine Lipid Supplement and Medium-Chain Triglyceride Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- History of seizure disorder or uncontrolled seizures.
- Use of opioid medications in the past 30 days.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Safety And Analgesic Efficacy of Marine Lipid Precursors of Specialized Pro-Resolving Mediators in Adults With Chronic Temporomandibular Pain
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Temporomandibular Disorder (TMD)
- Being tested
- SPM Precursor-Enriched Marine Lipid Supplement, Medium-Chain Triglyceride Supplement
- 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
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain, Anxiety Disorders, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPM Precursor-Enriched Marine Lipid SupplementDietary 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 SupplementDietary supplement
Participants receive matched placebo softgels daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Medium-Chain Triglyceride Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 2 (Mid-study, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start25 Sep 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorder (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 symptom diaries; secondary outcomes include self-administered questionnaires and pressure pain thresholds measured using a handheld algometer.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Metagenics LLC
- Responsible party
- Sponsor
- Investigators
- Anne E Sanders, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437313
- Sponsor's protocol ID
- 25-0878
- Other IDs
- UG3DE033354
- Acronym
- ADAPT
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Analgesic Efficacy of Marine Lipid Precursors of Specialized Pro-Resolving Mediators in Adults With Chronic Temporomandibular Pain
- ClinicalTrials.gov ID
- NCT07437313
- Acronym / sponsor ID
- ADAPT / 25-0878
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Metagenics LLC
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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 symptom diaries; secondary outcomes include self-administered questionnaires and pressure pain thresholds measured using a handheld algometer.
| Arm | Type | Receives |
|---|---|---|
| SPM precursor marine lipid dietary supplement | Experimental | Dietary Supplement: SPM Precursor-Enriched Marine Lipid SupplementExperimental 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. |
| Medium-chain triglyceride dietary supplement | Placebo comparator | Dietary Supplement: Medium-Chain Triglyceride SupplementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPM Precursor-Enriched Marine Lipid SupplementParticipants receive omega-3 SPM precursor-enriched marine lipid softgels administered daily for 8 weeks at the dose specified in the protocol. | Dietary supplement | SPM precursor marine lipid dietary supplement |
| Medium-Chain Triglyceride SupplementParticipants receive matched placebo softgels daily for 8 weeks. | Dietary supplement | Medium-chain triglyceride dietary supplement |
Primary outcome
Change in average weekly facial pain intensity
Time frame: Baseline (week prior to randomization) through Week 8 (final visit, Day 56 ±7)
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.
Rate of treatment-emergent adverse events
Time frame: From first dose (Visit 1/Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)
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.
9 secondary outcomes
Change in TMD pain duration
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
Time frame: Visit 1 (Randomization, Day 0) to Visit 3 (Final visit, Day 56 ±7)
Change in headache 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
Time frame: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in pressure pain thresholds
Time frame: Visit 0 (Screening/Baseline, 7-21 days before Visit 1), Visit 3 (Final visit, Day 56 ±7)
Change in state anxiety
Time frame: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in depression
Time frame: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in TMD-related quality of life
Time frame: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in overall status
Time frame: Visit 2 (Mid-study, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: 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.
Related trials for Temporomandibular Disorder (TMD)
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Recruiting
Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders
Temporomandibular Disorders (TMD), TMJ Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne E Sanders, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPM Precursor-Enriched Marine Lipid Supplement and Medium-Chain Triglyceride Supplement in people with Temporomandibular Disorder (TMD), run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne E Sanders, PhD ((919) 246-5833, adaptsms@adapt.study), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average weekly facial pain intensity (time frame: Baseline (week prior to randomization) through Week 8 (final visit, Day 56 ±7)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.