Actively Recruiting
An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis
Led by Erchonia Corporation · Updated on 2025-01-31
70
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has voluntarily signed a written informed consent form.
- Male or female 22 to 75 years of age, inclusive.
- No evidence of Localized Aggressive Periodontitis.
- Tooth loss due to periodontitis of 4 teeth or fewer.
- Two or more non-3rd molar teeth with Stage III periodontitis as classified by the American Academy of Periodontology, with no caries, abscess infection, or previous periodontal surgery within the prior 12 months.
- Agreement to adhere to study-provided home care instructions to maintain adequate oral hygiene.
- Agreement to refrain from using smokeless chewing tobacco during the study.
- Agreement to refrain from exceeding 40 milligrams per day of inhaled nicotine, including cigarettes, e-cigarettes, and cigars.
- Agreement to avoid any other periodontitis treatments outside the study during participation.
You will not qualify if you...
- Gingival recession caused by genetics, orthodontic treatment, frenulum attachments, or dental malocclusion.
- History of oral cancer or HIV within the last 6 months.
- Pregnant or intending to become pregnant within the next 8 months.
- Sensitivity to or contraindication for light therapy.
- Currently enrolled in another clinical study involving an investigational drug or device.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
805 Dentistry
Thousand Oaks, California, United States, 91360
Actively Recruiting
2
Acton Dental Associates
Acton, Massachusetts, United States, 01720
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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