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

Part of paid clinical trials in Thousand Oaks, California.

Sponsor
Erchonia Corporation
Study ID
NCT06656325
Status
Recruiting
Apply to this trial

Conditions

  • Gum Disease
  • Periodontal Diseases
  • Periodontitis

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Erchonia® FX405 — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Erchonia® FX405
    The Erchonia® FX405 is made up of (3) 6405 nanometers red laser diodes and (1) 405 nanometers violet laser diode mounted in a robotic scanner device.
  • Placebo Comparator: Placebo Laser
    The Placebo Laser has the same appearance as the Erchonia® FX405 but does not emit any therapeutic light.

Primary Outcome Measure

Number of participants with a change in Clinical Attachment Loss of ≥-2mm at the primary tooth assessment site [ Time Frame: Baseline and 8 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
805 DentistryThousand OaksCalifornia91360
Dar Radfar, DDS
[email protected]
805-273-8857
Acton Dental AssociatesActonMassachusetts01720
Eric Block, DMD
[email protected]
978-881-5826

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