Erchonia FX-405 Laser for Gum Disease
(R-GUM Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Erchonia Corporation
Disqualifiers: Gingival recession, Oral cancer, HIV, others
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Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you must not engage in any other treatments for periodontitis outside the study during your participation.
What data supports the effectiveness of the Erchonia FX-405 Laser treatment for gum disease?
Research on similar lasers, like the Er:YAG laser, shows they can effectively treat gum disease by removing bacteria and calculus (hardened plaque) and improving gum health. This suggests that the Erchonia FX-405 Laser might also be effective for gum disease.
12345Is the Erchonia FX-405 Laser safe for use in humans?
Research on similar lasers, like the Er:YAG laser, shows that when used with the right settings, they generally do not cause harmful effects on tissues, suggesting they can be safe for human use.
678910How does the Erchonia FX-405 Laser treatment for gum disease differ from other treatments?
The Erchonia FX-405 Laser treatment for gum disease is unique because it uses a specific type of laser technology, likely similar to the Er:YAG laser, which has been shown to effectively treat both hard and soft tissues in the mouth. This laser treatment can precisely target and treat affected areas, potentially offering a less invasive and more precise alternative to traditional surgical methods.
1231112Eligibility Criteria
This trial is for individuals with periodontitis, including those with diabetes-related gum issues. Participants should need treatment for their gum disease and be able to undergo procedures like scaling and root planing.Inclusion Criteria
Subject has voluntarily signed a written informed consent form
I do not have aggressive gum disease.
Subject agrees to refrain from engaging in any other treatments for periodontitis outside the scope of this study during participation
+6 more
Exclusion Criteria
Pregnant or intending to become pregnant in the next 8 months
Currently enrolled in a clinical study of an investigational drug or device
My gum recession is not caused by gum disease.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the active Erchonia FX-405 laser treatment or a placebo laser, in combination with periodontal scaling and root planing
8 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the Erchonia FX-405 laser's effectiveness as an additional treatment alongside standard care (scaling and root planing) in improving periodontal disease outcomes compared to a placebo laser.
2Treatment groups
Active Control
Placebo Group
Group I: Erchonia® FX405Active Control1 Intervention
The Erchonia® FX405 is made up of (3) 6405 nanometers red laser diodes and (1) 405 nanometers violet laser diode mounted in a robotic scanner device.
Group II: Placebo LaserPlacebo Group1 Intervention
The Placebo Laser has the same appearance as the Erchonia® FX405 but does not emit any therapeutic light.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
805 DentistryThousand Oaks, CA
Acton Dental AssociatesActon, MA
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Who Is Running the Clinical Trial?
Erchonia CorporationLead Sponsor
References
[Clinical evaluation of Er:YAG laser in the treatment of grade Ⅱ periodontitis with bifurcation lesions]. [2022]To evaluate the clinical efficacy of erbium-doped yttrium aluminium garnet (Er: YAG) laser in the treatment of degree II bifurcation periodontitis.
Effect of laser-induced dentin modifications on periodontal fibroblasts and osteoblasts: a new in vitro model. [2016]The erbium-doped:yttrium, aluminum, and garnet (Er:YAG) laser has been shown to be a promising tool for root treatment in periodontitis, but little information is available regarding the surface characteristics after this treatment, mainly because it is difficult to obtain standardized dentin samples for in vitro studies.
Potential applications of Erbium:YAG laser in periodontics. [2022]Since lasers were introduced for the treatment of oral diseases, there has been considerable advancement in technology. As a result, numerous laser systems are currently available for oral use. Neodymium:Yttrium-Aluminum:Garnet (Nd:YAG), carbon dioxide (CO(2)) laser and the semiconductor Diode lasers have already been approved by the US Food and Drug Administration for soft tissue treatment in oral cavity. The Erbium:YAG (Er:YAG) laser was approved in 1997 for hard tissue treatment in dentistry and recent studies have reported positive results. This suggests that the Er:YAG laser system is a promising apparatus, which will be able to revolutionize and improve dental practice, in particular periodontal treatment. In this mini-review, we would like to describe the positive characteristics of the Er:YAG laser which indicate its potential as a new treatment modality in periodontics.
Root Surface Bio-modification with Erbium Lasers- A Myth or a Reality?? [2022]The objective of this literature review was to critically review the evidence available in the literature regarding the expediency of erbium family of lasers for root bio modification as a part of periodontal therapy. The literature search was performed on the Pubmed using MeSH words such as "lasers/therapeutic use, scaling, dental calculus, tooth root/anatomy and histology, ultrasonic therapy". The studies were screened and were grouped as follows: those evaluating a) efficacy for calculus removal with the Erbium family of laser b) root surface changes following Er YAG and Er Cr YSGG application c) comparative studies of the Er YAG, Er Cr YSGG lasers versus conventional methods of root surface modification d) Bio compatibility of root surface following Erbium laser treatment e) Studies on the combined efficacy of laser root modification with conventional methods towards root surface bio-modification f) Studies on effectiveness of root surface bio-modification prior to root coverage procedures. In conclusion, the erbium family has a proven anti-bacterial action, predictable calculus removal, minimal root substance removal, and appears to favor cell attachment. The Erbium family of lasers appears to be a useful adjunct for the management of periodontal disease.
Comparative evaluation of photoablative efficacy of erbium: yttrium-aluminium-garnet and diode laser for the treatment of gingival hyperpigmentation. A randomized split-mouth clinical trial. [2014]The use of lasers in periodontology is a matter of debate, mainly because of the lack of consensual therapeutic protocols. In this randomized, split-mouth trial, the clinical efficacy of two different photoablative dental lasers, erbium:yttrium-aluminum-garnet (Er:YAG) and diode, for the treatment of gingival hyperpigmentation is compared.
Effectiveness of diode laser and fluoride on dentin hypersensitivity treatment: A randomized single-blinded clinical trial. [2022]This randomized single-blinded clinical trial aimed to evaluate the effectiveness of diode laser and fluoride in the treatment of dentin hypersensitivity (DH) due to gingival recession.
Clinical evaluation of a resin-modified glass-ionomer liner for cervical dentin hypersensitivity treatment. [2015]To evaluate the effectiveness of two agents for treating cervical dentin sensitivity associated with gingival recession or noncarious cervical lesions.
In vivo and in vitro effects of an Er:YAG laser, a GaAlAs diode laser, and scaling and root planing on periodontally diseased root surfaces: a comparative histologic study. [2022]The aim of the present histologic study was to compare the in vivo and in vitro effects of an erbium: yttrium, aluminum, and garnet (Er:YAG) laser (ERL), combined with a fluorescent calculus detection system, a diode laser (DL) and scaling and root planing (SRP) on periodontally diseased root surfaces.
Histological examination of experimentally infected root canals after preparation by Er:YAG laser irradiation. [2021]The influence of Er:YAG laser irradiation on periodontal tissues along the root surface and apical region during root canal preparation was histologically evaluated using experimentally infected root canals of rats. Eighty experimentally mesial infected root canals of mandibular first molars in rats were divided into four groups. In three groups, root canals were irradiated using an Er:YAG laser at 2 Hz with 34, 68, or 102 mJ/pulse for 30 s. Non-irradiated canals served as controls. The influence of laser irradiation on periodontal tissues along the root surface and apical area was evaluated histologically under light microscopy at 0 (immediately after), 1, 2, 4, and 8 weeks after irradiation. At all periods, no inflammation or resorption on the root surfaces caused by laser irradiation was observed in any cases in the control or 34 mJ/pulse-irradiated groups. However, mild to severe inflammation with resorption of root surfaces was observed in some cases in the 68- and 102-mJ/pulse-irradiated groups. No significant difference was apparent between control and laser-irradiated groups at the apical area for all experimental periods (p > 0.05). These results suggest that thermal influences on periodontal tissues of experimentally infected root canals during root canal preparation by Er:YAG laser irradiation are minimal if appropriate parameters are selected. Er:YAG laser irradiation is thus a potential therapy for human infected root canals.
Effects on periradicular periodontal tissues of root canal irradiation with Er:YAG laser in rats. [2015]The effects of Er:YAG laser irradiation on the periodontal region during root canal preparation were evaluated using rats histopathologically.
Esthetic treatment of gingival melanin hyperpigmentation with Er:YAG laser: short-term clinical observations and patient follow-up. [2019]Recently, the erbium-doped:yttrium, aluminum, and garnet (Er:YAG) laser has been applied effectively for periodontal soft tissue management. The purpose of this study was to report removal of gingival melanin pigmentation using an Er:YAG laser in a short-term clinical observation.
Simultaneous Perio-endo Surgery with ER:YAG Laser and Bone Xenograft. A Case Report. [2021]Periodontally affected teeth with periapical lesion indicated for periapical surgery have a poor prognosis. Using Er:YAG lasers to perform simultaneous surgery on both defects may increase their survival rate. Preparing a retrograde cavity on affected teeth and obturating it is still a matter of debate among clinicians. The purpose of this case report was to describe the simultaneous use of Erbium-doped Yttrium Aluminium Garnet Er:YAG (2,940 nm) laser in the treatment of periapical granuloma and infraossal defect and the achieved results. The Er:YAG laser was used to perform flap dissection, granulation tissue removal, osteotomy and root-end resection except for initial flap incision and reflection. The cystic cavity was filled with Bio-Oss Collagen® xenograft. Results were followed up for 18 months with the help of radiographic orthopantomographic images. The outcome of this clinical case indicates that the use of Er:YAG laser could be considered a suitable method to perform simultaneous periodontal and endodontic surgery.