Evaluating the Safety and Efficacy of the BTL-043 Device in Alleviating Temporomandibular Joint (TMJ) Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 3
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Sensory loss in the treatment area
- •Deep vein thrombosis