EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief (NCT07661121)
Evaluating the Safety and Efficacy of the BTL-043 and BTL-785F Devices in Alleviating Temporomandibular Joint (TMJ) Pain
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: The Dental Touch — Leesburg, Florida
Age range: 22 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- The Dental Touch — Leesburg, Florida
- Chandra Wellness Center — Ocala, Florida
- Applegate Dentistry & MedSpa — Covington, Kentucky
- Stonebriar Smile Design — Frisco, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Temporomandibular Disorder (TMD)
- Patient Education, Self-management and Physiotherapy for Chronic Temporomandibular Disorders — Montreal, Quebec
- Marine Lipids Ease Painful TMD — Chapel Hill, North Carolina
- JIT: Effect of Pain on DT in TMD — Minneapolis, Minnesota
Explore by condition: All Temporomandibular Disorder (TMD) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.