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Erchonia FX-405 Laser for Gum Disease (R-GUM Trial)

N/A
Waitlist Available
Research Sponsored by Erchonia Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has no evidence of Localized Aggressive Periodontitis
Tooth loss due to periodontitis of ≤ 4 teeth
Must not have
History of oral cancer or HIV in the last 6 months
Gingival recession not due to periodontitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 months

Summary

"This trial aims to see if using the Erchonia® FX-405 device along with standard periodontal treatment can help improve the outcomes for patients with periodontal disease."

Who is the study for?
This trial is for individuals with periodontitis, including those with diabetes-related gum issues. Participants should need treatment for their gum disease and be able to undergo procedures like scaling and root planing.
What is being tested?
The study tests the Erchonia FX-405 laser's effectiveness as an additional treatment alongside standard care (scaling and root planing) in improving periodontal disease outcomes compared to a placebo laser.
What are the potential side effects?
Since this trial involves a noninvasive laser, side effects may include temporary discomfort at the site of application or mild irritation but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have aggressive gum disease.
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I have lost up to 4 teeth due to gum disease.
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I am between 22 and 75 years old.
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I have at least two teeth with gum disease as defined by dental standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had oral cancer or HIV in the last 6 months.
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My gum recession is not caused by gum disease.
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I am sensitive to or cannot have light therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with a change in Clinical Attachment Loss of ≥-2mm at the primary tooth assessment site

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Erchonia® FX405Active Control1 Intervention
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.
Group II: Placebo LaserPlacebo Group1 Intervention
The Placebo Laser has the same appearance as the Erchonia® FX405 but does not emit any therapeutic light.

Find a Location

Who is running the clinical trial?

Erchonia CorporationLead Sponsor
44 Previous Clinical Trials
1,999 Total Patients Enrolled
~47 spots leftby Jan 2027
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