ClinicalTrials.gg
RecruitingNCT06656325Updated May 18, 2026

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

An interventional study of Erchonia® FX405 and Placebo Laser in Periodontal Diseases, Periodontitis and Gum Disease, sponsored by Erchonia Corporation. Recruiting at 2 sites in United States. Open to participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-18.

Primary conditionPeriodontitisRegistry: Periodontal DiseasesReclassifiedWhy we changed it
Registry
Periodontal Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Periodontitis
Why
  1. The study's listed conditions name Periodontitis, a narrower term within Periodontal Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Erchonia Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
22 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 75 studies in Periodontitis with a site in United States — 13 open to participants now, 16 under way, none of them phase 3. Periodontitis · United States.

Planned enrollment
25th of 56
70 · median 58
Started
2025
with 3 others
No phase
34 of 75
5 open now
Primary completion
2027-06
later than 11 of 14 live
Registered
66th of 75
by date

Among the 75 studies in Periodontitis with a site in United States, this one is the 25th largest by planned enrollment of the 56 interventional ones that give a count, is one of 4 that started in 2025, is one of 34 with no phase, reaches primary completion later than 11 of the 14 other live ones, and was the 66th registered.

Periodontitis

1,235 studies on the registry are indexed under Periodontitis; 298 are open to participants now.

Browse Periodontitis studies →

Open to participants now

13 of the 75 studies in Periodontitis with a site in United States are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 160 Periodontitis studies recruiting now, 79 (49%) set no upper age limit and 60 (38%) stop at 75 or younger; 12 take children under 18; 77 take healthy volunteers.

This study: 22 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 75 studies in Periodontitis with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed description

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. This clinical study is a double-blind design, such that neither the subject, nor the investigators - the investigator administering the treatment with the Erchonia® FX-405™ device (administration investigator) or the investigator recording the outcome measures (assessment investigator) - will be aware of whether the subject has been assigned to the active treatment test group or to the sham treatment control group until after the study is complete. All study subjects, regardless of treatment group assignment will receive active scaling and root planing standard of care therapy in addition to the active or sham therapy with the Erchonia® FX-405™ device.

03

Conditions studied

  • Periodontal Diseases
  • Periodontitis
  • Gum Disease

Browse trials for

04

In context

Periodontitis Reclassified

1,235 studies on the registry are indexed under Periodontitis; 298 are open to participants now.

This study's planned enrollment of 70 is above the median of 44 across 848 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Erchonia Corporation is the lead sponsor of 48 studies on the registry; 2 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.

Compared within Periodontitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
22 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject has voluntarily signed a written 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

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 in the last 6 months
  • Pregnant or intending to become pregnant in the next 8 months.
  • Sensitivity to, or for, light therapy.
  • Currently enrolled in a clinical study of an drug or device.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study 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.

    Device: Erchonia® FX405

  • Placebo comparator
    Placebo Laser

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

    Device: Placebo Laser

Interventions

  • DeviceErchonia® 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.

  • DevicePlacebo 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.

07

What researchers measure

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.

    Time frame: Baseline and 8 months

08

Study locations

2 of 2 sites recruiting
  • 805 Dentistry
    Thousand Oaks, California 91360, United States
    Recruiting
  • Acton Dental Associates
    Acton, Massachusetts 01720, United States
    Recruiting
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Jun 2027, 29 months after the start.

Of 496 interventional studies with no phase under Periodontitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 29 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2024
First posted
Oct 24, 2024
StartActual
Jan 1, 2025
Primary completionEst.
Jun 1, 2027
CompletionEst.
Aug 1, 2027
Last update
May 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06656325
Responsible party
Sponsor
First posted
Oct 24, 2024
Start date
Jan 1, 2025
Primary completion
Jun 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
May 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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