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New treatment option for Periodontal Diseases
Official title An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis
ClinicalTrials.gov ID: NCT06656325
What this study is testing
- What it's testing
- 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 is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- 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...
You likely can't join if
- Gingival recession which may be genetic, induced secondary to orthodontic treatment, induced secondary to frenulum attachments, or present as a...
- 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.
See the full 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Thousand Oaks, California, United States
- Acton, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thousand Oaks, California, United States; Acton, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.