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ACTIVE NOT RECRUITING
NCT07661121
NA

EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief

Sponsor: BTL Industries Ltd.

View on ClinicalTrials.gov

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

DEVICE

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