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Marine Lipider Lindrer Smertefull TMD (ADAPT)

2. november 2026 oppdatert av: University of North Carolina, Chapel Hill

Sikkerhet og analgetisk effekt av marine lipidforløpere til spesialiserte pro-oppløsningsmediatorer hos voksne med kronisk temporomandibulær smerte

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • Rekruttering
        • University of North Carolina at Chapel Hill

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SPM precursor marine lipid dietary supplement

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.
Kosttilskudd: SPM Precursor-Enriched Marine Lipid Supplement

Participants receive omega-3 SPM precursor-enriched marine lipid softgels administered daily for 8 weeks at the dose specified in the protocol.
Placebo komparator: Medium-chain triglyceride dietary supplement

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.
Kosttilskudd: Medium-Chain Triglyceride Supplement

Participants receive matched placebo softgels daily for 8 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in average weekly facial pain intensity
Tidsramme: 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.
Baseline (week prior to randomization) through Week 8 (final visit, Day 56 ±7)
Rate of treatment-emergent adverse events
Tidsramme: 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.
From first dose (Visit 1/Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in TMD pain duration
Tidsramme: From Visit 1 (Randomization, Day 0) through 7 days after the final dose (Visit 3, Day 56 ±7)

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

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.
Visit 1 (Randomization, Day 0) to Visit 3 (Final visit, Day 56 ±7)
Change in headache impact
Tidsramme: Visit 1 (Randomization, Day 0); Visit 2 (Mid-study visit, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)

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

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.
Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in pressure pain thresholds
Tidsramme: Visit 0 (Screening/Baseline, 7-21 days before Visit 1), Visit 3 (Final visit, Day 56 ±7)

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.
Visit 0 (Screening/Baseline, 7-21 days before Visit 1), Visit 3 (Final visit, Day 56 ±7)
Change in state anxiety
Tidsramme: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)

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.
Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in depression
Tidsramme: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)

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.
Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in TMD-related quality of life
Tidsramme: Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)

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.
Visit 1 (Randomization, Day 0); Visit 3 (Final visit, Day 56 ±7)
Change in overall status
Tidsramme: Visit 2 (Mid-study, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)

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.
Visit 2 (Mid-study, Day 28 ±7); Visit 3 (Final visit, Day 56 ±7)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of North Carolina, Chapel Hill

Samarbeidspartnere

National Institute of Dental and Craniofacial Research (NIDCR)
Metagenics LLC

Etterforskere

  • Hovedetterforsker: Anne E Sanders, PhD, University of North Carolina, Chapel Hill

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. september 2026

Primær fullføring (Antatt)

1. januar 2030

Studiet fullført (Antatt)

1. februar 2030

Datoer for studieregistrering

Først innsendt

20. februar 2026

Først innsendt som oppfylte QC-kriteriene

20. februar 2026

Først lagt ut (Faktiske)

27. februar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25-0878
  • UG3DE033354 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

beginning 9 and continuing for 36 months following publication

Tilgangskriterier for IPD-deling

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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