Periodontal DiseasesNCT06656325
An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis
A study testing Erchonia® FX405 in people with Periodontal Diseases and Periodontitis, run by Erchonia Corporation at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Gum Disease
- What is being tested?
- Erchonia® FX405
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2025to 1 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Acton Dental Associates
Acton, Massachusetts, 01720
Eric Block, DMD, 978-881-5826, info@actondental.com
- Recruiting
805 Dentistry
Thousand Oaks, California, 91360
Dar Radfar, DDS, 805-273-8857, darradfar@gmail.com
About this study
Official title: An Evaluation of the Effect of the Erchonia Corporation FX-405 Laser as an Adjunctive Treatment of Periodontitis
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.
- Conditions
- Periodontal Diseases, Periodontitis, Gum Disease
- Being tested
- Erchonia® FX405, Placebo Laser
- Medical subject headings
- Periodontal Diseases, Periodontitis, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia® FX405Device
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 LaserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Jan 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656325
- Sponsor's protocol ID
- R-GUM
- Status last verified
- May 2026
- First submitted
- 22 Oct 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes