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

Last updated: January 29, 2025
Sponsor: Erchonia Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Erchonia® FX405

Placebo Laser

Clinical Study ID

NCT06656325
R-GUM
  • Ages 22-75
  • All Genders

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.

Eligibility Criteria

Inclusion

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) andRBL, as classified by the American Academy of Periodontology (AAP), No evidence ofcaries, No abscess infection, No previous periodontal surgery within the prior 12months

  • Subject agrees to adhere to study provided home care instructions to maintainadequate oral hygiene during the study duration.

  • Subject agrees to refrain from the use of smokeless chewing tobacco for the studyduration.

  • 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 herperiodontitis that is outside the scope of this study during his or herparticipation in this study

Exclusion

Exclusion Criteria:

  • Gingival recession which may be genetic, induced secondary to orthodontic treatment,induced secondary to frenulum attachments, or present as a result of dentalmalocclusion.

  • 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.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Erchonia® FX405
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
February 01, 2027

Study 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.

Connect with a study center

  • 805 Dentistry

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • Acton Dental Associates

    Acton, Massachusetts 01720
    United States

    Active - Recruiting

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