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EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief

16. juni 2026 oppdatert av: BTL Industries Ltd.

Evaluating the Safety and Efficacy of the BTL-043 and BTL-785F Devices in Alleviating Temporomandibular Joint (TMJ) Pain

This prospective, multi-center, open-label, single-arm clinical study will evaluate the efficacy and performance of the BTL-043 and BTL-785F devices for alleviating TMJ pain. Up to 60 subjects will undergo four treatment visits, administered 2-10 days apart, followed by 1-month and 3-month follow-up visits. During a single treatment session at each visit, subjects will receive consecutive treatment with both devices. At baseline, informed consent, eligibility assessment, Fitzpatrick phototype evaluation, TMD Disability Index, VAS, weight and height measurements, 2D mandibular ROM photographs, and mandibular/lateral ROM assessments will be completed. A urine pregnancy test will be performed prior to each treatment visit. After the final treatment, subjects will complete the TCQ, SSQ & QoL, TMD Disability Index, and VAS, and repeat all physical assessments. At both follow-up visits, subjects will complete the SSQ & QoL, TMD Disability Index, and VAS, and repeat the physical assessments. Safety will be evaluated through documentation and assessment of adverse events at each treatment and follow-up visit.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

48

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Florida
      • Leesburg, Florida, Forente stater, 34748
        • The Dental Touch
      • Ocala, Florida, Forente stater, 34471
        • Chandra Wellness Center
    • Kentucky
      • Covington, Kentucky, Forente stater, 41011
        • Applegate Dentistry & MedSpa
    • Texas
      • Frisco, Texas, Forente stater, 75034
        • Stonebriar Smile Design

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age 22 years and older
  • Voluntarily signed an informed consent form
  • Subject is willing to comply with study instructions, to return to the clinic for the required visits
  • Willingness to adhere to and continue current pain management plan
  • Subjects willing and able to maintain their regular (pre-procedure) diet, exercise and therapy regimen without significant change during study participation
  • Subject is willing and able to abstain from partaking in any new treatments other than this study procedure to treat TMJ pain

  • Women of child-bearing potential* are required to use birth control measures during the whole duration of the study

    • Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Exclusion Criteria:

  • Major systemic diseases - e.g., uncontrolled Diabetes mellitus, systemic lupus erythematosus
  • Current pregnancy, nursing, or IVF procedure
  • Photosensitivity, medications affecting sensitivity to light
  • Tattoos or other higher pigmented regions in the treated area
  • Corticosteroids or injections of the treated area within the last 3 months, long-term corticosteroids use
  • Anticoagulant therapy, bleeding disorders
  • Hemorrhage in the treated area
  • Application over the thyroid or other endocrine glands
  • Subjects currently undergoing, or who have received, radiation therapy or chemotherapy within the past 6 months prior to study treatment
  • Known or suspected malignancy, history of cancer, any type of malignancy or pre-malignant moles
  • Febrile conditions, serious illness, chronic infection
  • Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
  • Sensory or sensitivity disorders in the treatment area
  • Active bacterial or viral infection, acute inflammation
  • Impaired immune system
  • Isotretinoin in the past 12 months
  • Skin-related autoimmune diseases
  • Poor healing and unhealed wounds in the treatment area
  • Metal implants near the treatment area or neutral electrode
  • Permanent implant near the treatment area
  • Pacemaker or internal defibrillator, or any other active electrical implant, anywhere in the body
  • Active collagen diseases
  • Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
  • Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
  • Any surgical procedure in the treatment area within the last three months or before complete healing
  • Tuberculosis
  • Hepatitis
  • Poorly controlled endocrine disorders
  • History of bleeding coagulopathies
  • Acute neuralgia and neuropathy
  • Kidney or liver failure
  • Skin dermabrasion, skin resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
  • Electroanalgesia without exact diagnose of pain etiology
  • Serious psychopathological disorders (such as schizophrenia)
  • Inflammation of blood or lymphatic vessels
  • Scarring in the treatment area
  • Swollen, infected, or inflamed areas or damaged skin, skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
  • Hypersensitive carotid sinus

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Treatment with BTL-043 and BTL-785F device
Enhet: Treatment with BTL-043 and BTL-785F
All subjects will receive a consecutive treatment with the BTL-043 and BTL-785F devices during a single visit. Subjects will be required to complete four (4) treatment visits and two (2) follow-up visits conducted at 1 month and 3 months after the last treatment.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months
Tidsramme: Baseline and 3 months
The Visual Analogue Scale (VAS) is a self-reported measure used to assess the intensity of TMJ-related pain experienced by the participants in the treatment area. Participants rate their perceived pain level on a numerical scale ranging from 0 to 10. On this scale, 0 is equivalent to "no pain" and 10 indicates the "worst possible pain". The baseline score is compared to the score collected at the 3-month follow-up visit. A negative change from baseline (a decrease in the VAS score) indicates a reduction in pain intensity and an improvement in the participant's condition over time.
Baseline and 3 months
Change from Baseline in the Temporomandibular Dysfunction (TMD) Disability Index Score at 3 Months
Tidsramme: Baseline and 3 months
The Temporomandibular Dysfunction (TMD) Disability Index is a self-reported questionnaire used to assess the impact of TMJ disorders on a participant's daily activities, such as talking, chewing, and sleeping. The questionnaire consists of 10 categories, each containing 5 statements. Each category is scored on a scale from 0 to 4, where 0 represents no limitation and 4 represents maximum restriction due to pain. The overall score is calculated by summing the scores of all 10 items, resulting in a total possible score ranging from 0 to 40. On this scale, a total score of 0 indicates no disability and 40 indicates extreme disability. A negative change from baseline (a decrease in the total score) indicates a reduction in disability and an improvement in the participant's condition over time.
Baseline and 3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in Mandibular Range of Motion at 3 Months
Tidsramme: Baseline and 3 months
Mandibular range of motion is measured objectively in millimeters (mm) using a specialized scale. Two measurements are taken: "comfort" (opening the mouth to a comfortable level without pain) and "active" (opening the mouth as wide as possible despite the presence of pain). A positive change from baseline (an increase in the measured mm) indicates an improvement in jaw mobility.
Baseline and 3 months
Incidence of Treatment-related Adverse Events
Tidsramme: From baseline up to 3 months post-treatment
Overall safety is evaluated continuously by monitoring, assessing, and recording the occurrence and severity of any adverse events, side effects, or unanticipated problems throughout the course of the study
From baseline up to 3 months post-treatment
Change from Baseline in Lateral Range of Motion at 3 Months
Tidsramme: Baseline and 3 months
Lateral mandibular range of motion is measured objectively in millimeters (mm) using a specialized scale. Two measurements are taken: left lateral excursion (moving the lower jaw as far as possible to the left) and right lateral excursion (moving the lower jaw as far as possible to the right). A positive change from baseline (an increase in the measured mm) indicates an improvement in lateral jaw mobility.
Baseline and 3 months
Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire
Tidsramme: 3 months post treatment
Subject satisfaction with the treatment outcomes and its impact on quality of life is assessed using a 17-item self-reported questionnaire. Each item is rated on a 5-point Likert scale, where 1 indicates "strongly disagree" and 5 indicates "strongly agree". Higher scores represent greater treatment satisfaction and improvement in the subject's quality of life.
3 months post treatment
Therapy Comfort Assessed by the Therapy Comfort Questionnaire
Tidsramme: Immediately after the final treatment
Therapy comfort is assessed using a self-reported questionnaire. Participants indicate their overall comfort on a 5-point Likert scale (where 1 is "strongly disagree" and 5 is "strongly agree" with the statement "I found the treatment comfortable"). Additionally, any pain experienced during treatment is rated on a Numerical Analogue Scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Lower pain scores and higher agreement scores indicate greater therapy comfort.
Immediately after the final treatment

Samarbeidspartnere og etterforskere

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

Sponsor

BTL Industries Ltd.

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)

8. desember 2025

Primær fullføring (Antatt)

1. august 2026

Studiet fullført (Antatt)

1. august 2026

Datoer for studieregistrering

Først innsendt

16. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BTL-043_CTUS400

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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