A Double-blind, Placebo-controlled Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJ
Part of paid clinical trials in Acton, Massachusetts.
- Sponsor
- Erchonia Corporation
- Study ID
- NCT07600203
- Status
- Recruiting
Conditions
- TMD
- TMJ
- TMJ Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Erchonia® EVRL™ — DEVICEThe Erchonia® EVRL™ is a handheld device containing one 635 nm red laser diode and one 405 nm violet laser diode. During treatment, the diodes are positioned approximately 3 to 4 inches from the skin over the temporomandibular joint area. Treatment is administered for a total of 16 minutes, with 8 minutes applied to each side.
- Placebo Device — DEVICEThe Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light. During treatment, the diodes are positioned approximately 3 to 4 inches from the skin over the temporomandibular joint area. Treatment is administered for a total of 16 minutes, with 8 minutes applied to each side.
Study Details
The purpose of this clinical study is to determine the effectiveness of the Erchonia EVRL, manufactured by Erchonia Corporation (the Company), in providing temporary relief of nociceptive musculoskeletal chronic jaw pain arising from temporomandibular joint (TMJ).
Key Dates
- Start date
- May 14, 2026
- Status verified
- May 2026
- Primary completion
- Dec 21, 2027
- Completion
- Dec 22, 2027
Study Design
- Enrollment
- 64 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Erchonia® EVRL™The Erchonia® EVRL™ is made up of (1) 635 nanometers red laser diode and (1) 405 nanometers violet laser diode mounted in a portable handheld device.
- Placebo Comparator: Placebo LaserThe Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.
Primary Outcome Measure
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) [ Time Frame: Baseline and immediately after treatment ]
Central Contacts
- Travis Sammons888-242-0571
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Acton Dental Associates | Acton | Massachusetts | 01720-5774 | Eric Block, DMD 978-263-3526 |
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