An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorErchonia Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Erchonia® FX405
DeviceProcedure administrations with the Erchonia® FX-405 will be applied eight times during the 5-month procedure administration phase. Phase One involves one procedure administration each week for 4 consecutive weeks. Phase 2 commences for one month following the completion of Phase One and involves one procedure administration each month for the next four consecutive months. Each procedure administration with the Erchonia FX405 takes 10 minutes and will be administered by the test site. Additionally, subjects will receive Scaling and Root Planing prior to the administration of the first procedure with the Erchonia FX405, and a second time at the 3-month study midpoint assessment visit.
Placebo Laser
DeviceProcedure administration with the Placebo Laser (emitting non therapeutic light) will be applied eight times during the 5-month procedure administration phase. Phase One involves one procedure administration each week for 4 consecutive weeks. Phase 2 commences for one month following the completion of Phase One and involves one procedure administration each month for the next four consecutive months. Each procedure administration with the Placebo Laser takes 10 minutes and will be administered by the test site. Additionally, subjects will receive Scaling and Root Planing prior to the administration of the first procedure with the Placebo Laser, and a second time at the 3-month study midpoint assessment visit.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Erchonia® FX405Active comparator 1 intervention
Group B: Placebo LaserPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with a change in Clinical Attachment Loss of ≥-2mm at the primary tooth assessment site
The Clinical Attachment Loss (CAL) from baseline to endpoint (8 months) measurement is calculated for each subject. Individual subject success is defined as a 2mm or greater change in CAL at the primary tooth assessment site across the evaluation period. A negative (-) change indicates a reduction in periodontitis and is positive for individual subject success. A lower CAL score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome.
Time frame
Baseline and 8 monthsSponsors and contacts
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Source ClinicalTrials.gov