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

Part of paid clinical trials in Leesburg, Florida.

Sponsor
BTL Industries Ltd.
Study ID
NCT07661121
Status
Active Not Recruiting

Conditions

  • Facial Pain
  • Neck Pain
  • Temporomandibular Disorder (TMD)
  • Temporomandibular Joint Pain

Eligibility Criteria

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

Interventions

  • Treatment with BTL-043 and BTL-785F — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 8, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

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

Arms

  • Active Comparator: Treatment with BTL-043 and BTL-785F device

Primary Outcome Measure

Change from Baseline in the Temporomandibular Dysfunction (TMD) Disability Index Score at 3 Months [ Time Frame: Baseline and 3 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
The Dental TouchLeesburgFlorida34748-
Chandra Wellness CenterOcalaFlorida34471-
Applegate Dentistry & MedSpaCovingtonKentucky41011-
Stonebriar Smile DesignFriscoTexas75034-

Find similar trials in Leesburg, FL

By research site
The Dental Touch· Leesburg, FLChandra Wellness Center· Ocala, FLApplegate Dentistry & MedSpa· Covington, KYStonebriar Smile Design· Frisco, TX

Related Studies