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

NCT07661121 | Active Not Recruiting FDA Device

• 1 other identifier: BTL-043_CTUS400
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Temporomandibular Disorder (TMD); Temporomandibular Joint Pain; Facial Pain; Neck Pain

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in the Temporomandibular Dysfunction (TMD) Disability Index Score at 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

• Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 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

Secondary Outcomes (5)

• Change from Baseline in Mandibular Range of Motion at 3 Months

  Baseline and 3 months

• Change from Baseline in Lateral Range of Motion at 3 Months

  Baseline and 3 months

• Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire

  3 months post treatment

• Therapy Comfort Assessed by the Therapy Comfort Questionnaire

  Immediately after the final treatment

• Incidence of Treatment-related Adverse Events

  From baseline up to 3 months post-treatment

Study Arms (1)

Treatment with BTL-043 and BTL-785F device

ACTIVE COMPARATOR

Device: Treatment with BTL-043 and BTL-785F

Interventions

Treatment with BTL-043 and BTL-785F DEVICE

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.

Treatment with BTL-043 and BTL-785F device

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (4)

The Dental Touch

Leesburg, Florida, 34748, United States

Location

Chandra Wellness Center

Ocala, Florida, 34471, United States

Location

Applegate Dentistry & MedSpa

Covington, Kentucky, 41011, United States

Location

Stonebriar Smile Design

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain; Neck Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: December 8, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (4)