Beginning in May of 2014, Millennium renewed its previously rejected overtures to communicate and collaborate with the AAP on a scientific statement on the LANAP Protocol. After Millennium submitted in good faith confidential and proprietary materials, the promised collaboration was quashed by the AAP.
Mark Monaghan, CEO of Millennium, stated, “We consider this publication in Periospectives by AAP to be in bad faith after we took great care to emphasize that the sharing of Millennium’s confidential and proprietary materials was conditioned upon a mutually agreeable scientific statement as the basis for a future ADA code. The conversation quickly became a one-way monologue of what AAP intended to do without further discussions with Millennium. No scientific position statement or specific code from AAP has been developed to date.”
The LANAP Protocol is a laser-based, minimally invasive and patient-preferred method of treating mild-to-severe cases of gum disease without the use of scalpels or sutures. The LANAP Protocol is supported by the 4th largest human histology scientific study with a control group – the gold standard of research – published in a prestigious, peer-reviewed periodontal journal and was the basis for the US Food and Drug Administration’s (FDA’s) decision to clear the PerioLase® MVP-7™ laser and “laser assisted new attachment procedure”, aka LANAP Protocol, in 2004 (510(k) K030290).
A second human histology study also published in a prestigious, peer-reviewed periodontal journal led to an even more impressive FDA clearance (510(k) K151763). On March 15, 2016, the FDA granted the PerioLase MVP-7 marketing clearance 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.” http://www.multivu.com/players/English/7795951-millennium-dental-technologies-lanap/
Dawn M. Gregg, DDS, Vice President of Operations for Millennium and Director of Training for the Institute for Advanced Laser Dentistry (IALD), stated, “It is utterly astonishing that the AAP can ignore the unequivocal language of the FDA, the abundance of scientific evidence, and all the confidential materials we shared with the AAP in arriving at their position.” Dr. Gregg continued, “The AAP and the FDA had the same information for the same two-year time frame in arriving at two very different conclusions.”
Additionally, the authors of the AAP Periospectives article knowingly misrepresented a case with the New Jersey State Board of Dentistry in a bad-faith attempt to discredit the LANAP Protocol and intimidate LANAP-trained specialists. They wrote, “The New JerseyBoard of Dentistry found a periodontist guilty of misleading an insurer by submitting code D4260, osseous surgery, for reimbursement of the LANAP procedure. The dentist was subsequently fined $10,000…”i
“This representation by AAP trustees is false and misleading, and its publication appears to be intended as a veiled threat to intimidate LANAP Protocol specialists and to harm Millennium’s business in attracting more LANAP Protocol practitioners,” according to Robert H. Gregg, DDS, President of MDT and co-inventor of the LANAP protocol.
Dr. Robert Gregg continued, “Overall, this publication is inflammatory and defamatory and hearkens back to the the previous century, 20 years ago, when early use of lasers to treat gingivitis and periodontal disease received similar mean-spirited and unprofessional commentary spawned by non-progressive influencers in AAP leadership. This behavior is unworthy of a professional organization.”
Mark Monaghan stated, “While attempts by the AAP to offer guiding information to the public and the profession regarding the use of the LANAP Protocol is a worthy objective, Millennium finds the lack of transparency involved in this process and the publication to be flawed and counterproductive.” Mr. Monaghan continued, “Ironically, approximately one-third of the active AAP members are trained and credentialed LANAP Protocol specialists.”
Furthermore, it is disingenuous at best for the AAP to suggest that “Either Millennium or dentists could develop such a code for consideration by the American Dental Association’s Code Maintenance Committee.” MDT is fully aware of the coding process, and that nothing passes approval on the ADA Code Committee without AAP’s support. The American Dental Association (ADA) owns the Code on Dental Procedures and Nomenclature (CDT) that dentists use to report to insurance companies what clinical procedures were accomplished in their actual treatment of patients.
This is the reason that Millennium reached out to AAP two years ago in an attempt to develop an accurate and up-to-date scientific understanding of the LANAP Protocol, a mutually agreeable scientific position statement, and a mutually agreeable change to the osseous code.
“The AAP has been very adept at obtaining unscientific changes to the ADA Code in recent years, specifically targeting the LANAP Protocol for changes to the code’s meaning. Ironically, the AAP’s rash behavior has now also impacted conventional scalpel surgical approaches that today no longer include the most invasive techniques for treating periodontitis–so-called full thickness flaps,” noted Dr. Robert Gregg. “In targeting the LANAP Protocol for the ADA code changes, the AAP inadvertently implied that the D4999 code is now the ‘new osseous’ code for current methods of osseous surgeries as well.”
“Instead of being a unifying and illuminating influence, the AAP has once again succeeded in casting a shadow over science, confusing the dental profession at large, the clinical practice of periodontics, and the insurance industry,” commented Dr. Dawn Gregg. “One reason might include a conflict of interest regarding the AAP’s own periodontist/insurance consultant who is a customer and user of a rival laser device.”
It is now up to the AAP leadership to correct its mistakes and provide meaningful direction to the ADA Coding Committee. The direction must include evidenced-based, scientifically sound, clinically meaningful coding and nomenclature for either revising the D4260 code or offering a new code for the LANAP Protocol. For over two years and to date, Millennium stands prepared to support this necessary cooperative initiative with the AAP for a collaborative endeavor.
Millennium Dental Technologies, Inc. is the manufacturer of the PerioLase MVP-7, the world’s first digital dental laser, now with a Samsung tablet for operational control and display, and which was specifically designed to support the LANAP Protocol with true regeneration. The company sponsors research to help add to the body of literature and help demonstrate the safety and efficacy of lasers for specific clinical outcomes that benefit patients.
NOTE TO EDITORS: Additional information can be viewed at http://www.lanap.com
SOURCE Millennium Dental Technologies, Inc.