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An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis
Sponsor: Erchonia Corporation
Summary
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.
Official title: An Evaluation of the Effect of the Erchonia Corporation FX-405 Laser as an Adjunctive Treatment of Periodontitis
Key Details
Gender
All
Age Range
22 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2025-01-01
Completion Date
2027-02-01
Last Updated
2025-01-31
Healthy Volunteers
No
Interventions
Erchonia® FX405
Procedure administrations with the Erchonia® FX-405 will be applied eight times during the 5-month procedure administration phase. Phase One involves one procedure administration each week for 4 consecutive weeks. Phase 2 commences for one month following the completion of Phase One and involves one procedure administration each month for the next four consecutive months. Each procedure administration with the Erchonia FX405 takes 10 minutes and will be administered by the test site. Additionally, subjects will receive Scaling and Root Planing prior to the administration of the first procedure with the Erchonia FX405, and a second time at the 3-month study midpoint assessment visit.
Placebo Laser
Procedure administration with the Placebo Laser (emitting non therapeutic light) will be applied eight times during the 5-month procedure administration phase. Phase One involves one procedure administration each week for 4 consecutive weeks. Phase 2 commences for one month following the completion of Phase One and involves one procedure administration each month for the next four consecutive months. Each procedure administration with the Placebo Laser takes 10 minutes and will be administered by the test site. Additionally, subjects will receive Scaling and Root Planing prior to the administration of the first procedure with the Placebo Laser, and a second time at the 3-month study midpoint assessment visit.
Locations (2)
805 Dentistry
Thousand Oaks, California, United States
Acton Dental Associates
Acton, Massachusetts, United States