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.
Sponsored by Erchonia Corporation · Not applicable, Interventional, and Treatment
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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.
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.
1,235 studies on the registry are indexed under Periodontitis; 298 are open to participants now.
Browse Periodontitis studies →13 of the 75 studies in Periodontitis with a site in United States are open now. Recruiting first, the newest first:
McGuire Institute · Sites in United States
Ages 30–75
Case Western Reserve University · Sites in United States
Ages 18+
University of Minnesota · Sites in United States
Ages 18+ · Healthy volunteers
Missouri Department of Health and Senior Services · Sites in United States
Ages 60–100 · Healthy volunteers
Texas A&M University · Sites in United States
Ages 30–75 · Healthy volunteers
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 →
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.
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75 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 9 · Phase 3 7 · Phase 4 2
First in 1999; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is above the median of 44 across 848 interventional studies indexed under Periodontitis.
Median enrollment 58 across the 56 interventional studies, 105 across the 18 observational. Of the 56 that completed or were terminated, 14 (25%) have results posted.
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16 of 75 have an industry lead sponsor. The 10 most frequent:
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.
Erchonia Corporation has 1 study filed under Periodontitis — fewer than ten, so there is no comparison to draw.
6 of the studies in Periodontitis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07610902Louisiana State University Health Sciences Center in New OrleansPeriodontal Inflammation and Epigenetics in Obese Individuals | 2026-12-30 |
| NCT06914596McGuire InstituteA Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Control Group Post-SRP. | 2026-12-30 |
| NCT04805320University of NebraskaAssociation of Periodontal Inflammation on Immune Response in Wound Healing | 2027-01 |
| NCT06948162University of MinnesotaExploration of the Utility of Dental-dedicated MRI for Dentistry | 2027-03-31 |
| NCT07298057Case Western Reserve UniversityEffect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics | 2027-06 |
Add all 6 to your calendar (.ics) → With an account.
Among the 75 studies in Periodontitis with a site in United States, from their registry updates:
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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.
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.
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 →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 →
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Exclusion Criteria:
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The Placebo Laser has the same appearance as the Erchonia® FX405 but does not emit any therapeutic light.
Device: Placebo Laser
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.
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.
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
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.
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No contact was published for this record. The registry link below has the sponsor’s details.
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