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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with BTL-043 | Experimental | Four (4) treatment sessions will be applied to the subjects' temporomandibular joint (TMJ) area using the BTL-043 device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Mandibular Range of Motion at 3 Months | Mandibular range of motion is measured objectively in millimeters (mm) using a specialized scale. Two measurements are taken: "comfort" (opening the mouth to a comfortable level without pain) and "active" (opening the mouth as wide as possible despite the presence of pain). A positive change from baseline (an increase in the measured mm) indicates an improvement in jaw mobility. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McCreight Progressive Dentistry | Steamboat Springs | Colorado | 80487 | United States | ||
| The Dental Touch |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D005157 | Facial Pain |
| D013706 | Temporomandibular Joint Dysfunction Syndrome |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Baseline and 3 months |
| Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire | Subject satisfaction with the treatment outcomes and its impact on quality of life is assessed using a 13-item self-reported questionnaire. Each item is rated on a 5-point Likert scale, where 1 indicates "strongly disagree" and 5 indicates "strongly agree". Higher scores represent greater treatment satisfaction and improvement in the subject's quality of life. | 3 months post treatment |
| Therapy Comfort Assessed by the Therapy Comfort Questionnaire | Therapy comfort is assessed using a self-reported questionnaire. Participants indicate their overall comfort on a 5-point Likert scale (where 1 is "strongly disagree" and 5 is "strongly agree" with the statement "I found the treatment comfortable"). Additionally, any pain experienced during treatment is rated on a Numerical Analogue Scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Lower pain scores and higher agreement scores indicate greater therapy comfort. | Immediately after the final (fourth) treatment |
| Incidence of Treatment-related Adverse Events | Overall safety is evaluated continuously by monitoring, assessing, and recording the occurrence and severity of any adverse events, side effects, or unanticipated problems throughout the course of the study | From baseline up to 3 months post-treatment |
| Leesburg |
| Florida |
| 34748 |
| United States |
| Chandra Wellness Center | Ocala | Florida | 34471 | United States |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009209 | Myofascial Pain Syndromes |