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Device for Alleviating Temporomandibular Joint (TMJ) Pain
Sponsor: BTL Industries Ltd.
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
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