• First FDA clearance for functional periodontal tissue regeneration as a result of a specific protocol and device

• True Regeneration™ of periodontal tissues previously lost to gum disease (new alveolar bone, new cementum, new periodontal ligament)

• True Regeneration is FDA cleared and only proven with the PerioLase® MVP-7™ and the LANAP® protocol

• LANAP protocol = LAR (Laser Assisted Regeneration)

• Full-mouth True Regeneration is now required Informed Patient Consent!

• 85% of U.S. adults have some level of periodontal disease!

• 50% of U.S. adults have moderate to severe gum disease. Of this group, 40% don’t know they have the disease, and only 3% accept traditional treatment.

The LANAP=LAR procedure with the PerioLase MVP-7 achieves True Regeneration:

• No foreign biologics

• No exogenous growth factors

• No bone grafts

• No artificial membranes

• No scaffolding

• No sutures

†Only FDA clearance for True Periodontal Regeneration with independent, peer-reviewed scientific proof on the LANAP protocol. *Full-mouth True Periodontal Regeneration

World’s First & ONLY Scientifically ProvenFDA Clearance for

†

*True Periodontal Regeneration™

Proven with Human Histology

PRE-OP

R. Gregg II, DDS, Cerritos, CA - General Dentist

1 YEAR POST 3 YEARS POST 6 YEARS POST

InitialPocket Depths:10, 13, 15 mm

6 Years Post-OpPocket Depths:

4, 3, 6 mm

The LANAP protocol has been proven with two human histology studies; the presence of new bone can clearly be seen in the histological review.

Predictable Positive ResultsIn this instance, the occlusal adjustment impacted the patient’s amalgam significantly. The choice was the patient‘s — keep the tooth in your mouth but potentially destroy the restoration; or keep the restoration; or keep the restoration intact by extracting the tooth.

LANAP Protocol Treatment ProcedureA key to the consistent positive results obtained with the LANAP protocol is the standardized protocol. Every LANAP specialist must complete 3 days of training before they are shipped a PerioLase MVP-7.

A .

B . PerioLase® MVP-7™ laser energy selectively vaporizes bacteria, endotoxins and diseased epithelial lining of the pocket; denatures pathologic proteins; and alerts the practitioner to the presence of calculus.

C.

D. Bone is modified to reshape, decorticate, and stimulate therelease of fresh blood, stem cells and growth factors. Angiogenesis is initiated.

E . PerioLase MVP-7 is used to form a stable fibrin clot, activate growth factors, and upregulate gene expression.

F. Rete ridges are repositioned to the clean root surface; red blood cells, fibroblasts, stem cells, and growth factors fill entire defect with a stable fibrin clot to the gingival crest to create a ‘closed system.’

G. Occlusal trauma is adjusted to eliminate excessive contacts and allow for passive eruption.

H. True Regeneration of new cementum, new periodontal ligament, and new alveolar bone occurs.

Periodontal probe bone sounding to full depth of bony defects.

Ultrasonic scaler and specialized tips are used to remove root surface calculus.

A B C D E F G H

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Revolutionary Clearance for True RegenerationThis world’s first FDA clearance for full-mouth periodontal tissue regeneration is groundbreaking in that Millennium Dental has demonstrated that tissues lost to disease can be fully regenerated, including return to functional health. www.TrueRegeneration.com

“Our preliminary understanding is that we are able to stimulate and activate stem cells, in particular fibroblasts, to form the necessary cellular components that turn into regenerated tissues. This is the first example of functional regeneration as a result of a full-mouth protocol and device, where full-mouth regeneration would otherwise not occur,” states Robert H. Gregg II, DDS, co-founder of MDT, Inventor of the LANAP® protocol, co-developer of the PerioLase® MVP-7™. “If we can regenerate tissues destroyed by infection and inflammation in a cesspool of saliva and bacteria, without exogenous growth factors, the implications for what else could be regenerated elsewhere in the body are worth investigation.”

The PerioLase® MVP-7™ received regulatory clearance using the LANAP®=LAR™ protocol 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 510(k)-151763).

True Regeneration is RevolutionaryFDA requires submission of new clinical and histological performance data for a new indication for use. Repair is not regeneration. Regeneration is a return to normal architecture and functional health; repair is not. True Regeneration™, following the LANAP protocol, can be obtained despite the presence of periodontal disease – one of the most stubborn, persistent, and widespread infectious diseases according to the Surgeon General and the CDC 2010 NHANES report.*

Over 2,200 LANAP Regenerative SpecialistsMDT has trained over 2,200 credentialed LANAP regenerative specialists, that include general practitioners and periodontists alike. LANAP regenerative specialists are found nationally in every U.S. state, plus Puerto Rico, the U.S. Virgin Islands, and Guam; as well as internationally.

This new FDA indication for use changes the meaning of ‘return to periodontal health.’ No longer is return to periodontal health defined by filling holes or cutting away tissue. The FDA clearance reflects what we understood from two human histological studies – the LANAP protocol produces both periodontal regeneration and functionality to previously diseased tissues.

As Chair of the Periodontics Department of Rutgers School of Dental Medicine, I was delighted to learn Millennium has received acknowledgment 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.

THIS IS THE FIRSTEXAMPLE OF FUNCTIONAL

FULL-MOUTH REGENERATION AS A RESULT OF A PROTOCOL

AND DEVICE, WHERE REGENERATION WOULD OTHERWISE NOT OCCUR.

Andrew Sullivan, DDS Chair of Periodontics at Rutgers

Dawn M. Gregg, DDSDirector of Training for the Institute for Advanced Laser Dentistry

* Journal of Dental Research on the prevalence of periodontal disease. (J Dent Res 89(11): 1208-1213, 2010).

Prof. Ray Yukna onTrue Regeneration

LANAP Protocol - lasergum disease treatment

Louis Rose, DDS, MD, onthe LANAP protocol

PerioLase I (Analog, Dual-Pulse)1999

PerioLase® MVP-7™ IntroducedFDA Clearance K010771

2001

Lloyd Tilt, DDS, MS 6-Year Retrospective Tooth Survival Study, Peer-Reviewed Published in General Dentistry [4]

2012

Marc Nevins Peer-Reviewed LANAP Human Histology Published in IJPRD [5]2012

LANAP Case Studies Published by I. Stephen Brown, Others [6]2013

Five-Site Multi-Centered Clinical Study Peer-Reviewed Published Manuscript [7];Marc Nevins 2nd Peer-Reviewed Published Manuscript in IJPRD [8]

2014

2016

Ongoing Research & Development2002

Raymond Yukna, DMD, MS, IADR LANAP Human Histology Abstract [1]

2003

IADR Yukna LANAP Human Histology Abstract II [2] ; FDA Clearance K030290

2004

Yukna LANAP Human Histology Manuscript Published in IJPRD [3]

2007

FDA Clearance for True Regeneration™510(k) 151763

LANAP Protocol TimelineQR Codes to Online Videos

The PerioLase MVP-7 is the only dental laser specifically designed for the LANAP protocol, optimized to target and destroy the bacteria causing gum disease for minimally-invasive, highly effective treatment.

21-06-011 Rev E

youtube.com/PerioLase4LANAP

Periodontal Regeneration in Humans Following the Laser Assisted New Attachment Procedure (LANAP). Proceedings of the 81st General Session of the International Association of Dental Research. (IADR) June 2003Human Periodontal Regeneration Following the Laser Assisted New Attachment Procedure. R.A. Yukna, G. Evans, S. Vastardis and R.L.Carr Louisiana State University, New Orleans, The IADR / AADR / CADR 82nd General Session March 10 -13, 2004, Honolulu, HIHistologic Evaluation of an Nd:YAG Laser Assisted New Attachment Procedure in Humans. IJPRD Peer-Reviewed Study. R.A. Yukna, R. L. Carr, G. EvansEffectiveness of LANAP over time as measured by tooth loss. Lloyd Tilt, DMD, MS. General Dentistry – Peer-reviewed article. March/April 2012. Human Clinical and Histologic Evaluation of Laser-assisted New Attachment Procedure. IJPRD Peer-Reviewed Study. Marc Nevins, DMD, MMSc, Marcelo Camelo, DDS, Peter Schupbach, PhD, Soo-Woo Kim, DMD, MS, et alCurrent Advances in the Use of Lasers in Periodontal Therapy: A Laser-Assisted New Attachment Procedure Case Series. I. Stephen Brown, DMD, MSD LANAP case study AbstractChange in clinical indices following laser or scalpel treatment for periodontitis: A split-mouth, randomized, multi-center trial. SPIE Vol. 8929 89290G-9. David M. Harris, PhD, Dawn M. Nicholson, DDS, et al. March 2014 A Prospective 9-Month Human Clinical Evaluation of Laser-Assisted New Attachment Procedure (LANAP) Therapy. January 2014. IJPRD Peer-Reviewed Study. Marc Nevins, DMD, MMSc, Marcelo Camelo, DDS, et al

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