Millennium Dental Technologies (MDT) is pleased to announce a first-of-its-kind 510(k) clearance from the Food and Drug Administration (FDA) for periodontal regeneration – true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® protocol.
FDA clearance for tissue regeneration by Millennium Dental Technologies demonstrates for the first time ever that tissues lost to disease can be fully regenerated and return to functional health.
Regeneration is the process of returning full function to diseased areas via the regrowth of tissue and bone that has been damaged or lost. Although the terms are often used interchangeably, "repair" and "regeneration" are different health care results.
The LANAP procedure creates true regeneration of tissues of the mouth that were damaged previously by disease using no biologics, growth factors, exogenous bone grafts, foreign membranes, scaffolding, scalpel, or stitches.
"Dentistry has become a driver of innovation in the field of regeneration and this is apparent with the FDA’s first-of-its kind clearance of the LANAP protocol and device," said Robert H. Gregg II, DDS, co-founder of MDT, inventor of the LANAP protocol and co-developer of the PerioLase® MVP-7™ variable pulsed Nd:YAG laser.
"The mouth is an unforgiving environment and the fact that we can stimulate regeneration with the full functionality will advance a broader scientific understanding of the body’s regenerative capability."
The LANAP protocol is the result of three decades of research, development and clinical testing, including human histology.
"Periodontal educators in academic institutions across the county now include the protocol in post-graduate periodontal residency training programs, as it is the only scientifically proven methodology that results in true periodontal regeneration including new gum tissue and bone growth and the regeneration of tissue and bone to save otherwise hopeless teeth," noted Dawn M. Gregg, DDS, MDT Director of Training.
Using the PerioLase MVP-7, the only free-running, variable pulsed laser specifically designed to perform the LANAP protocol, doctors stimulate and activate oral stem cells, in particular fibroblasts, to form the necessary cellular components that turn into regenerated tissue. This 1064nm laser wavelength passes through healthy tissue and is selectively absorbed in bacteria and diseased tissues without harming other tissues.
The energy from the PerioLase MVP-7 laser, operating at near-infrared beyond the light spectrum visible to humans, penetrates 4-6mm beyond the tissue surface to kill bacteria thereby eliminating infection and inflammation.
Once the mouth has been cleared of infectious agents, the laser interacts with hemoglobin to seal the gums with stable fibrin clotting, to achieve a clean, closed environment to create true regeneration. Multiple peer-reviewed, post procedure studies tracking results over time, show increased regeneration and continued improvement of oral health.
"The use of this highly calibrated laser to activate stem cells and growth factors validates years of testing and represents a significant improvement over traditional osseous surgery and conventional deep cleaning," noted Dr. Robert Gregg.
"This new FDA indication for use changes the meaning of ‘return to periodontal health’ and reinforces our significant advances in dental care and beyond. Indeed, there are implications into medical regenerative treatments."
The LANAP, laser assisted regeneration (LAR) protocol, is currently used by more than 2,000 credentialed LANAP specialists across the United States to treat infectious, epidemic periodontal disease.
Compared to classic osseous surgery or versions of scalpel-flap surgery for gum disease, patients treated with the LANAP protocol experience less pain, bleeding, swelling, sensitivity, gum loss, tooth loss and post-operative infections.
Andrew Sullivan, DDS, Chair of Periodontics at Rutgers, said, "As Chair of the Periodontics Department of Rutgers School of Dental Medicine, I was delighted to learn Millennium has received acknowledgement from the FDA that LANAP can achieve the "Gold Standard" in periodontal therapy – true periodontal regeneration. Rutgers periodontal residents are trained in the most advanced techniques, including the LANAP protocol."
The LANAP protocol, cleared by the FDA for periodontal regeneration is an important inclusion in patients’ informed consent as a recommended treatment option for periodontitis.