Acton

Researchers are evaluating the Erchonia4 EVRL device to determine its effectiveness in providing temporary relief for chronic jaw pain caused by temporomandibular joint TMJ disorders. This clinical study focuses on nociceptive musculoskeletal pain arising from TMJ and aims to measure changes in pain levels and jaw function. The study compares the Erchonia4 EVRL, a handheld device with red and violet laser diodes, to a placebo device that looks identical but emits no therapeutic light. Treatments involve positioning the device 3 to 4 inches from the skin over the TMJ area, applying laser therapy for 16 minutes total, with 8 minutes on each side. Participants are randomly assigned to receive either the active device or placebo in a triple-blind design. Participants will undergo assessments of pain using a visual analog scale VAS and mouth opening measurements before and immediately after treatment. The primary outcome is the number of participants achieving a 30% or greater reduction in pain rating. The study includes adults aged 22 to 75 with ongoing jaw pain lasting at least three months. Safety and effectiveness will be monitored throughout the trial, which runs until December 2027.

Researchers are studying the effectiveness of the Erchonia FX-405 laser device as a noninvasive additional treatment combined with standard periodontal scaling and root planing to improve care for people with periodontal disease. This clinical study uses a double-blind design, meaning neither the participants nor the investigators know who receives the actual laser treatment or a placebo until the study ends. Both groups receive active scaling and root planing along with either the active or sham laser therapy. Participants will receive eight procedure administrations of either the active Erchonia FX-405 laser or the placebo laser over a five-month period. The treatment phase is divided into two parts one procedure weekly for four weeks, followed by one procedure each month for the next four months. Each laser session lasts 10 minutes and is given at the test site. Additionally, all subjects receive scaling and root planing before the first laser procedure and again at the three-month midpoint visit. During the study, participants will be evaluated at baseline and at eight months to measure changes in clinical attachment loss at the primary tooth assessment site. Researchers will monitor oral health and periodontal status through clinical assessments. Participants are asked to follow study home care instructions and avoid certain tobacco and nicotine products throughout the study. The total study duration includes the initial screening and the treatment and follow-up phases up to eight months.