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EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief
Sponsor: BTL Industries Ltd.
Summary
This prospective, multi-center, open-label, single-arm clinical study will evaluate the efficacy and performance of the BTL-043 and BTL-785F devices for alleviating TMJ pain. Up to 60 subjects will undergo four treatment visits, administered 2-10 days apart, followed by 1-month and 3-month follow-up visits. During a single treatment session at each visit, subjects will receive consecutive treatment with both devices. At baseline, informed consent, eligibility assessment, Fitzpatrick phototype evaluation, TMD Disability Index, VAS, weight and height measurements, 2D mandibular ROM photographs, and mandibular/lateral ROM assessments will be completed. A urine pregnancy test will be performed prior to each treatment visit. After the final treatment, subjects will complete the TCQ, SSQ \& QoL, TMD Disability Index, and VAS, and repeat all physical assessments. At both follow-up visits, subjects will complete the SSQ \& QoL, TMD Disability Index, and VAS, and repeat the physical assessments. Safety will be evaluated through documentation and assessment of adverse events at each treatment and follow-up visit.
Official title: Evaluating the Safety and Efficacy of the BTL-043 and BTL-785F Devices in Alleviating Temporomandibular Joint (TMJ) Pain
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-12-08
Completion Date
2026-08
Last Updated
2026-06-22
Healthy Volunteers
No
Interventions
Treatment with BTL-043 and BTL-785F
All subjects will receive a consecutive treatment with the BTL-043 and BTL-785F devices during a single visit. Subjects will be required to complete four (4) treatment visits and two (2) follow-up visits conducted at 1 month and 3 months after the last treatment.
Locations (4)
The Dental Touch
Leesburg, Florida, United States
Chandra Wellness Center
Ocala, Florida, United States
Applegate Dentistry & MedSpa
Covington, Kentucky, United States
Stonebriar Smile Design
Frisco, Texas, United States