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September 2016
Volume 37, Issue 8

World’s First–and Only–FDA Clearance for True Regeneration

Robert H. Gregg II, DDS, was looking for a better way to help his periodontal patients who were refusing treatment due to their own fears. In developing the PerioLase® MVP-7™ and the LANAP® protocol, he found something revolutionary.

“During the development of the LANAP protocol (formerly Laser ENAP), we spoke about regeneration based on the radiographic results we were seeing in our patients. I was firmly told that in order to say ‘regeneration’ we needed to conduct human histology studies to confirm no adverse events would occur, such as ankylosis, and that we have restored the entire attachment apparatus,” says Gregg, who is president and Chairman of the board for Millennium Dental Technologies. “We began the steps we needed to prove true periodontal regeneration, not just to others but also to ourselves.”

Just this year, the PerioLase MVP-7 became the only 510(k) Food and Drug Administration-cleared device—in dental and medical fields—that can make the claim of attachment-apparatus regeneration. The FDA 510(k) clearance 151763 reads, “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.”

“The clearance states that we can regrow alveolar bone, not just repair the damage done by gingival disease, but a true regeneration of all three components needed for full function,” Gregg says. “This is the first regenerative clearance not just in dentistry, but in all of medicine, and achieves the gold standard defined by the specialty and science. What this means for ailing and failing implants is that the LAPIP™ protocol is applicable to predictably achieve the elimination of the inflammation around the implant and deliver the optimal conditions for new bone growth around the implant.” LAPIP protocol is used for treating peri-implantitis.

“The FDA clearance reinforces the clinical results we see every single day,” says Gregg, who also has a private practice in Cerritos, California, and uses the laser routinely. “LANAP is hope for hopeless teeth in patients desperate for options other than invasive surgeries and grafts. I see patients in my practice and the patients treated during training. Their amazement at how simple and painless the treatment is combined with the renewed confidence in their own health is what keeps us moving forward. Our philosophy was, is, and continues to be: ‘It’s all about the patient.’”

The wavelength of the PerioLase MVP-7 targets the diseased tissue without harming healthy tissue, and the laser light penetrates 4 mm beyond the tissue surface for effective bacteria kill. Once the site is clean, the laser interacts with the patient’s hemoglobin to create a stable fibrin clot.

“The FDA clearance of True Periodontal regeneration means every dentist has the ability to take control of the most infectious disease in their practice and generate new bone without bone grafts or growth factors despite the cesspool of bacteria associated with periodontitis and peri-implantitis,” Gregg says. “The No Cut, No Sew, No Fear approach minimizes recession, giving patients the best possible esthetic results with less pain and morbidity.”

The PerioLase MVP-7 is capable of a range of procedures, Gregg explains.

“The 7 variable pulse durations allow for a variety of optimized treatment solutions: LARIP, a laser-assisted alveolar ridge preservation technique; dentin etch to improve bond strength by 70%; locating and opening calcified canals; removal of enamel caries and organic debris prior to bonding; extraction site hemostasis for eliminating dry sockets; and many more value-added procedures.”

There are many reasons for clinicians to invest in this technology. Gregg points first to providing the best care to a clinician’s patients. Today’s economy combines low interest rates for financing and IRS Section 179 benefits for a large practice write-off. “No longer do patients settle for invasive surgery or aggressive treatment. Instead, you can reverse bone destruction and offer salvation to an otherwise condemned implant. LAPIP is the only patient-friendly, minimally invasive solution for ailing and failing implants. You’re building a solid foundation back for the implant and saving your patient’s implant investment without invasive surgeries,” Gregg says.

“The journey, with over 27 years of clinical experience, research, and novel FDA clearances, has given us the high confidence to say the protocol works and removes the risk, fear, and doubt of incorporating the LANAP protocol,” Gregg says. “It works for dentists who follow the protocol, and it works for patients. It also gives us further appreciation that dentists have an opportunity—indeed, an obligation—to help their patients to understand, to diagnose, and to treat periodontal and peri-implant disease, while increasing their own professional success and personal satisfaction.”

Millennium Dental Technologies, Inc.
10945 South St, Suite 104-A
Cerritos, CA 90703

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