Using a laser treatment to help improve gum disease management
An Evaluation of the Effect of the Erchonia Corporation FX-405 Laser as an Adjunctive Treatment of Periodontitis
This study is testing if a special laser treatment can help improve the results of regular gum disease care for people receiving standard dental cleaning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Erchonia Corporation Industry-sponsored |
| Locations | 2 sites (Thousand Oaks, California and 1 other locations) |
| Trial ID | NCT06656325 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness of the Erchonia® FX-405 laser as a noninvasive adjunctive treatment for periodontal disease when combined with standard periodontal scaling and root planing. The study employs a double-blind design, ensuring that neither participants nor investigators know who receives the active treatment versus a sham treatment until the study concludes. All participants will receive the standard care of scaling and root planing, alongside either the active laser treatment or a placebo. The goal is to determine if the laser can enhance the outcomes of traditional gum disease treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 to 75 with mild to moderate periodontitis and limited tooth loss.
Not a fit: Patients with localized aggressive periodontitis or significant prior periodontal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for managing periodontal disease, potentially leading to better oral health outcomes.
How similar studies have performed: While the use of lasers in periodontal treatment is gaining interest, this specific approach with the Erchonia FX-405 is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Thousand Oaks, California and 1 other locations
- 805 Dentistry — Thousand Oaks, California, United States (Recruiting)
- Acton Dental Associates — Acton, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.