RECRUITING

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

Talk to us

Conditions

Periodontal DiseasesPeriodontitisGum Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-01
Study Completion:2027-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06656325

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.

Ages Eligible for Study:22 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject has voluntarily signed a written informed consent form.
  2. * Male or female 22 to 75 years of age, inclusive.
  3. * Subject has no evidence of Localized Aggressive Periodontitis.
  4. * Tooth loss due to periodontitis of ≤ 4 teeth.
  5. * 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
  6. * Subject agrees to adhere to study provided home care instructions to maintain adequate oral hygiene during the study duration.
  7. * Subject agrees to refrain from the use of smokeless chewing tobacco for the study duration.
  8. * Subject agrees to refrain from exceeding 40 milligrams per day of inhaled nicotine, encompassing cigarettes, electronic cigarettes, and cigars.
  9. * 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
  1. * Gingival recession which may be genetic, induced secondary to orthodontic treatment, induced secondary to frenulum attachments, or present as a result of dental malocclusion.
  2. * History of oral cancer or HIV in the last 6 months
  3. * Pregnant or intending to become pregnant in the next 8 months.
  4. * Sensitivity to, or contraindication for, light therapy.
  5. * Currently enrolled in a clinical study of an investigational drug or device.

Contacts and Locations

Study Locations (Sites)

805 Dentistry
Thousand Oaks, California, 91360
United States
Acton Dental Associates
Acton, Massachusetts, 01720
United States

Collaborators and Investigators

Sponsor: Erchonia Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01
Study Completion Date2027-02-01

Study Record Updates

Study Start Date2025-01-01
Study Completion Date2027-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Periodontal Diseases
  • Periodontitis
  • Gum Disease