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COMPLETED
NCT07624539
NA

Device for Alleviating Temporomandibular Joint (TMJ) Pain

Sponsor: BTL Industries Ltd.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2024-08-21

Completion Date

2025-05-14

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

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.

Locations (3)

McCreight Progressive Dentistry

Steamboat Springs, Colorado, United States

The Dental Touch

Leesburg, Florida, United States

Chandra Wellness Center

Ocala, Florida, United States