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

Running, not enrolling · Not applicable

Conditions studied: Temporomandibular Disorder (TMD), Temporomandibular Joint Pain, Facial Pain, Neck Pain

In brief

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.

Key facts

Study ID: NCT07661121
Run by: BTL Industries Ltd.
People needed: 48
Starts: 2025-12-08
Expected to finish: 2026-08-01
Last updated by the study team: 2026-06-22

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

The Dental Touch — Leesburg, Florida, United States
Chandra Wellness Center — Ocala, Florida, United States
Applegate Dentistry & MedSpa — Covington, Kentucky, United States
Stonebriar Smile Design — Frisco, Texas, United States

Full record on ClinicalTrials.gov

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