New device combo aims to quiet jaw pain without drugs
NCT ID NCT07661121
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether two devices, used one after the other, can reduce pain and disability from temporomandibular joint (TMJ) disorders. Adults aged 22 and older with TMJ pain will receive four treatment sessions and be followed for three months. Researchers will measure changes in pain levels, jaw movement, and daily function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BTL-043 and BTL-785F devices
- What this could lead to
- If effective, these devices could offer a non-drug option for reducing TMJ pain and improving jaw function.
- What could go wrong
- This is a small, early-stage study with no control group, so results may not be conclusive. Pain relief may vary or be temporary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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48 people
The number who actually took part.
- Started
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Dec 2025
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Applegate Dentistry & MedSpa
Covington, Kentucky, 41011, United States
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Chandra Wellness Center
Ocala, Florida, 34471, United States
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Stonebriar Smile Design
Frisco, Texas, 75034, United States
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The Dental Touch
Leesburg, Florida, 34748, United States
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