Study of the Erchonia FX-405 Laser Used Alongside Standard Gum Disease Treatment to Improve Periodontitis in Adults Aged 22 to 75

What this Trial Is About

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.

An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis