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

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

January 1, 2027

Study Completion Date

February 1, 2027

Conditions
Periodontal DiseasesPeriodontitisGum Disease
Interventions
DEVICE

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."

DEVICE

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."

Trial Locations (2)

91360

RECRUITING

805 Dentistry, Thousand Oaks

01720

RECRUITING

Acton Dental Associates, Acton

Sponsors
All Listed Sponsors
lead

Erchonia Corporation

INDUSTRY