Temporomandibular Disorder (TMD)NCT07661121
EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief
A study testing Treatment with BTL-043 and BTL-785F in people with Temporomandibular Disorder (TMD) and Temporomandibular Joint Pain, run by BTL Industries Ltd. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Temporomandibular Disorder (TMD), Temporomandibular Joint Pain, Facial Pain
- What is being tested?
- Treatment with BTL-043 and BTL-785F
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Dec 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 38Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Applegate Dentistry & MedSpa
Covington, Kentucky, 41011
Stonebriar Smile Design
Frisco, Texas, 75034
The Dental Touch
Leesburg, Florida, 34748
Chandra Wellness Center
Ocala, Florida, 34471
About this study
Official title: 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.
- Being tested
- Treatment with BTL-043 and BTL-785F
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BTL-043 and BTL-785FDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BTL-043 and BTL-785F device | Active comparator | Not described Receives: Device: Treatment with BTL-043 and BTL-785F |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 3 months
Secondary outcomes (5)
Change from Baseline in Mandibular Range of Motion at 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.
Measured: Baseline and 3 months
Change from Baseline in Lateral Range of Motion at 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.
Measured: Baseline and 3 months
Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire
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.
Measured: 3 months post treatment
Therapy Comfort Assessed by the Therapy Comfort Questionnaire
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.
Measured: Immediately after the final treatment
Incidence of Treatment-related Adverse Events
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
Measured: From baseline up to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start8 Dec 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorder (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661121
- Sponsor's protocol ID
- BTL-043_CTUS400
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of the BTL-043 and BTL-785F Devices in Alleviating Temporomandibular Joint (TMJ) Pain
- ClinicalTrials.gov ID
- NCT07661121
- Acronym / sponsor ID
- BTL-043_CTUS400
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with BTL-043 and BTL-785F device | Active comparator | Device: Treatment with BTL-043 and BTL-785F |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with BTL-043 and BTL-785FAll 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. | Device | Treatment with BTL-043 and BTL-785F device |
Primary outcome
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.
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.
5 secondary outcomes
Change from Baseline in Mandibular Range of Motion at 3 Months
Time frame: Baseline and 3 months
Change from Baseline in Lateral Range of Motion at 3 Months
Time frame: Baseline and 3 months
Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire
Time frame: 3 months post treatment
Therapy Comfort Assessed by the Therapy Comfort Questionnaire
Time frame: Immediately after the final treatment
Incidence of Treatment-related Adverse Events
Time frame: From baseline up to 3 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with BTL-043 and BTL-785F in people with Temporomandibular Disorder (TMD) and Temporomandibular Joint Pain, run by BTL Industries Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Temporomandibular Dysfunction (TMD) Disability Index Score at 3 Months (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.