Using a laser treatment to help improve gum disease management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 805 Dentistry
  Thousand Oaks, California, United States Recruiting
• Acton Dental Associates
  Acton, Massachusetts, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.