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

Description

The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-405 (manufactured by Erchonia Corporation (the Company) in providing a noninvasive adjunctive treatment in combination with periodontal scaling and root planing for improving the treatment of periodontal disease. This clinical study is a double-blind design, such that neither the subject, nor the investigators – the investigator administering the treatment with the Erchonia® FX-405™ device (administration investigator) or the investigator recording the outcome measures (assessment investigator) – will be aware of whether the subject has been assigned to the active treatment test group or to the sham treatment control group until after the study is complete. All study subjects, regardless of treatment group assignment will receive active scaling and root planing standard of care therapy in addition to the active or sham therapy with the Erchonia® FX-405™ device.