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I Lipidi Marini Alleviano il Dolore del DTM (ADAPT)

2 novembre 2026 aggiornato da: University of North Carolina, Chapel Hill

Sicurezza ed Efficacia Analgesica dei Precursori Lipidici Marini dei Mediator Specializzati Pro-Risoluzione in Adulti con Dolore Cronico Temporomandibolare

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • Reclutamento
        • University of North Carolina at Chapel Hill

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Integratore alimentare: 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.
Comparatore placebo: 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.
Integratore alimentare: Medium-Chain Triglyceride Supplement

Participants receive matched placebo softgels daily for 8 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in average weekly facial pain intensity
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in TMD pain duration
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 settembre 2026

Completamento primario (Stimato)

1 gennaio 2030

Completamento dello studio (Stimato)

1 febbraio 2030

Date di iscrizione allo studio

Primo inviato

20 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 febbraio 2026

Primo Inserito (Effettivo)

27 febbraio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-0878
  • UG3DE033354 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

beginning 9 and continuing for 36 months following publication

Criteri di accesso alla condivisione IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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