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

16 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

48

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Treatment with BTL-043 and BTL-785F device
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Mandibular Range of Motion at 3 Months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

BTL Industries Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 december 2025

Primaire voltooiing (Geschat)

1 augustus 2026

Studie voltooiing (Geschat)

1 augustus 2026

Studieregistratiedata

Eerst ingediend

16 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 juni 2026

Eerst geplaatst (Werkelijk)

22 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BTL-043_CTUS400

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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