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

June 16, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Treatment with BTL-043 and BTL-785F device
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Mandibular Range of Motion at 3 Months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BTL Industries Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTL-043_CTUS400

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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