Device for Alleviating Temporomandibular Joint (TMJ) Pain

Evaluating the Safety and Efficacy of the BTL-043 Device in Alleviating Temporomandibular Joint (TMJ) Pain

The goal of this clinical trial is to evaluate the safety and effectiveness of the investigational BTL-043 device in alleviating Temporomandibular Joint (TMJ) pain in adults aged 22 years and older. The main questions it aims to answer are:

Does the BTL-043 device effectively reduce TMJ pain? Does the treatment improve jaw mobility (mandibular range of motion) and reduce the impact of TMJ disorders on daily activities? Is the treatment comfortable and safe for participants?

Participants will:

Receive four 20-minute treatments with the BTL-043 laser, spaced 2 to 10 days apart.

Attend follow-up clinic visits 1 month and 3 months after their final treatment.

Complete questionnaires about their pain levels (Visual Analogue Scale), daily activities (TMD Disability Index), and treatment comfort and satisfaction.

Have their jaw mobility (mandibular range of motion) measured

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain
• Intervention / Treatment: Device: Treatment with BTL-043

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Steamboat Springs, Colorado, United States, 80487
      • McCreight Progressive Dentistry
  • Florida
    • Leesburg, Florida, United States, 34748
      • The Dental Touch
    • Ocala, Florida, United States, 34471
      • Chandra Wellness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults seeking alleviation of pain in the treatment area
• 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 affecting significant change during study participation
• Subject 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
• 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
• Application within 4 to 6 months after radiotherapy
• Known or suspected malignancy, history of cancer or any type of malignancy
• Febrile conditions, serious illness, chronic infection
• Epilepsy
• Sensory loss in the treatment area
• Deep vein thrombosis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with BTL-043; Four (4) treatment sessions will be applied to the subjects' temporomandibular joint (TMJ) area using the BTL-043 device.	Device: Treatment with BTL-043; Four (4) treatment sessions will be applied to the subjects' temporomandibular joint (TMJ) area using the BTL-043 system (a Class IV laser operating at a 1064 nm wavelength). Each treatment session lasts 20 minutes and is spaced 2 to 10 days apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 13-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	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 (fourth) 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	From baseline up to 3 months post-treatment

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Actual): May 14, 2025
• Study Completion (Actual): May 14, 2025

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Myofascial Pain Syndromes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain; Therapeutics
• Other Study ID Numbers: BTL-043_CTUS200

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