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

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.

Conditions

Periodontal Diseases, Periodontitis, Gum Disease

Study Overview

Study Details

Study overview

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.

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

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

Condition
Periodontal Diseases
Intervention / Treatment

-

Contacts and Locations

Thousand Oaks

805 Dentistry, Thousand Oaks, California, United States, 91360

Acton

Acton Dental Associates, Acton, Massachusetts, United States, 01720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

22 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Erchonia Corporation,

Study Record Dates

2027-02-01