NCT06656325 An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis
| NCT ID | NCT06656325 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erchonia Corporation |
| Condition | Periodontal Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-01-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 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 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.
Frequently Asked Questions
Who can join the NCT06656325 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 75 Years, studying Periodontal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06656325 currently recruiting?
Yes, NCT06656325 is actively recruiting participants. Visit ClinicalTrials.gov or contact Erchonia Corporation to inquire about joining.
Where is the NCT06656325 trial being conducted?
This trial is being conducted at Thousand Oaks, United States, Acton, United States.
Who is sponsoring the NCT06656325 clinical trial?
NCT06656325 is sponsored by Erchonia Corporation. The trial plans to enroll 70 participants.