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

NCT06656325 | Recruiting FDA Device

• 1 other identifier: R-GUM
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with a change in Clinical Attachment Loss of ≥-2mm at the primary tooth assessment site

  The Clinical Attachment Loss (CAL) from baseline to endpoint (8 months) measurement is calculated for each subject. Individual subject success is defined as a 2mm or greater change in CAL at the primary tooth assessment site across the evaluation period. A negative (-) change indicates a reduction in periodontitis and is positive for individual subject success. A lower CAL score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome.

  Baseline and 8 months

Study Arms (2)

Erchonia® FX405

ACTIVE COMPARATOR

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.

Device: Erchonia® FX405

Placebo Laser

PLACEBO COMPARATOR

The Placebo Laser has the same appearance as the Erchonia® FX405 but does not emit any therapeutic light.

Device: Placebo Laser

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.

Erchonia® FX405

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.

Placebo Laser

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (2)

805 Dentistry

Thousand Oaks, California, 91360, United States

RECRUITING

Acton Dental Associates

Acton, Massachusetts, 01720, United States

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Gingival Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (2)