Actively Recruiting
An Evaluation of the Effect of the Erchonia Corporation FX-405 Laser as an Adjunctive Treatment of Periodontitis
Led by Erchonia Corporation · Updated on 2026-05-18
70
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of the Erchonia FX-405 laser device as a noninvasive additional treatment combined with standard periodontal scaling and root planing to improve care for people with periodontal disease. This clinical study uses a double-blind design, meaning neither the participants nor the investigators know who receives the actual laser treatment or a placebo until the study ends. Both groups receive active scaling and root planing along with either the active or sham laser therapy. Participants will receive eight procedure administrations of either the active Erchonia FX-405 laser or the placebo laser over a five-month period. The treatment phase is divided into two parts: one procedure weekly for four weeks, followed by one procedure each month for the next four months. Each laser session lasts 10 minutes and is given at the test site. Additionally, all subjects receive scaling and root planing before the first laser procedure and again at the three-month midpoint visit. During the study, participants will be evaluated at baseline and at eight months to measure changes in clinical attachment loss at the primary tooth assessment site. Researchers will monitor oral health and periodontal status through clinical assessments. Participants are asked to follow study home care instructions and avoid certain tobacco and nicotine products throughout the study. The total study duration includes the initial screening and the treatment and follow-up phases up to eight months.
CONDITIONS
Brief 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 teeth or fewer.
- Two or more non-third molar teeth with Stage III periodontitis (severity) as classified by the American Academy of Periodontology.
- No evidence of caries, abscess infection, or previous periodontal surgery within the prior 12 months at affected teeth.
- Agreement to follow study-provided home care instructions to maintain oral hygiene.
- Agreement to refrain from using smokeless chewing tobacco during the study.
- Agreement to limit inhaled nicotine use to 40 milligrams per day or less.
- Agreement to avoid any other periodontitis treatments outside the study during participation.
You will not qualify if you...
- Gingival recession due to genetic reasons, orthodontic treatment, frenulum attachments, or 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 another clinical study involving an investigational drug or device.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 months
Participants receive periodontal scaling and root planing before beginning the laser procedure. They then undergo eight laser procedure administrations over five months, including weekly sessions for the first four weeks and monthly sessions for the following four months. A second scaling and root planing treatment occurs at the three-month study midpoint.
8 visits (in-person)
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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