Device for Alleviating Temporomandibular Joint (TMJ) Pain

NCT07624539 | Completed FDA Device

• 1 other identifier: BTL-043_CTUS200
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Temporomandibular Joint Disorders; Facial Pain; Temporomandibular Joint Dysfunction Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change from Baseline in Mandibular Range of Motion at 3 Months

  Baseline and 3 months

• Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire

  3 months post treatment

• Therapy Comfort Assessed by the Therapy Comfort Questionnaire

  Immediately after the final (fourth) treatment

• Incidence of Treatment-related Adverse Events

  From baseline up to 3 months post-treatment

Study Arms (1)

Treatment with BTL-043

EXPERIMENTAL

Four (4) treatment sessions will be applied to the subjects' temporomandibular joint (TMJ) area using the BTL-043 device.

Device: Treatment with BTL-043

Interventions

Treatment with BTL-043 DEVICE

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.

Treatment with BTL-043

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

McCreight Progressive Dentistry

Steamboat Springs, Colorado, 80487, United States

Location

The Dental Touch

Leesburg, Florida, 34748, United States

Location

Chandra Wellness Center

Ocala, Florida, 34471, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain; Temporomandibular Joint Dysfunction Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myofascial Pain Syndromes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start: August 21, 2024
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

US (3)