Recruiting

Erchonia FX-405

Sponsor:

Erchonia Corporation

Code:

NCT06656325

Conditions

Periodontal Diseases

Periodontitis

Gum Disease

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Erchonia® FX405

Placebo Laser

Study Details

Brief 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.

Conditions

Periodontal Diseases

Periodontitis

Gum Disease

Study ID

NCT06656325

Start date

Jan 1, 2025

Status verified date

May, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject has voluntarily signed a written informed consent form.
  • Male or female 22 to 75 years of age, inclusive.
  • Subject has no evidence of Localized Aggressive Periodontitis.
  • Tooth loss due to periodontitis of ≤ 4 teeth.
  • Two or more teeth with the following characteristics: Non 3rd molar, Periodontitis: Stage III (Severity) according to the Interdental CAL (at site of greatest loss) and RBL, as classified by the American Academy of Periodontology (AAP), No evidence of caries, No abscess infection, No previous periodontal surgery within the prior 12 months
  • Subject agrees to adhere to study provided home care instructions to maintain adequate oral hygiene during the study duration.
  • Subject agrees to refrain from the use of smokeless chewing tobacco for the study duration.
  • Subject agrees to refrain from exceeding 40 milligrams per day of inhaled nicotine, encompassing cigarettes, electronic cigarettes, and cigars.
  • Subject agrees to refrain from engaging in any other treatments for his or her periodontitis that is outside the scope of this study during his or her participation in this study

Exclusion Criteria:

  • Gingival recession which may be genetic, induced secondary to orthodontic treatment, induced secondary to frenulum attachments, or present as a result of dental malocclusion.
  • History of oral cancer or HIV in the last 6 months
  • Pregnant or intending to become pregnant in the next 8 months.
  • Sensitivity to, or contraindication for, light therapy.
  • Currently enrolled in a clinical study of an investigational drug or device.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

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 ]

Central Contacts and Locations

Locations

805 Dentistry

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Dar Radfar, DDS

805-273-8857darradfar@gmail.com

Acton Dental Associates

Recruiting

Acton, Massachusetts, United States, 01720

Contacts

Eric Block, DMD

978-881-5826info@actondental.com

More Information

Sponsor

Erchonia Corporation

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Erchonia Corporation on 2026-05-18.