Device for Alleviating Temporomandibular Joint (TMJ) Pain

Part of paid clinical trials in Steamboat Springs, Colorado.

Sponsor
BTL Industries Ltd.
Study ID
NCT07624539
Status
Completed

Conditions

  • Facial Pain
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Aug 21, 2024
Status verified
May 2026
Primary completion
May 14, 2025
Completion
May 14, 2025

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months [ Time Frame: Baseline and 3 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
McCreight Progressive DentistrySteamboat SpringsColorado80487-
The Dental TouchLeesburgFlorida34748-
Chandra Wellness CenterOcalaFlorida34471-

Find similar trials in Steamboat Springs, CO

By research site
McCreight Progressive Dentistry· Steamboat Springs, COThe Dental Touch· Leesburg, FLChandra Wellness Center· Ocala, FL

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