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New device combo aims to quiet jaw pain without drugs

NCT ID NCT07661121

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

48 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

22 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Applegate Dentistry & MedSpa

    Covington, Kentucky, 41011, United States

  • Chandra Wellness Center

    Ocala, Florida, 34471, United States

  • Stonebriar Smile Design

    Frisco, Texas, 75034, United States

  • The Dental Touch

    Leesburg, Florida, 34748, United States

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