Forums › Nd:YAG lasers › General Nd:YAG Forum › First Laser Gum Disease Procedure to gain FDA Clearance
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Robert Gregg DDSSpectatorhttp://www.prnewswire.com/mnr/millenium/20513/
First Laser Gum Disease Procedure to gain FDA Clearance – “Laser Assisted New Attachment Procedure or Laser-ANAP®”
CERRITOS, Calif., October 8, 2004 / PRNewswire / – Millennium Dental Technologies, Inc. (MDT) announced today it has received the first FDA clearance ever for a laser-based periodontal (gum) disease treatment protocol while using the first ever digital dental laser–the PerioLase® MVP-7™.
50 people out of 100 have moderate to severe gum disease, 40 out of the 50 don’t know it, and only 3 people out of 100 will ever get treated before it’s too late.
Gum disease is a silent, painless, chronic, communicable, bacterial infection that often goes undetected or ignored until severe gum and bone destruction catch the individual’s attention. Traditional treatments for gum disease have, until Laser-ANAP, been perceived as painful with a long and uncomfortable recovery, scaring patients away and causing the epidemic numbers suffering with this preventable and now attractively treatable disease.
The US Food and Drug Administration cleared Laser-ANAP® (“Laser Assisted New Attachment Procedure” ) with a unique and specific claim for, “cementum-mediated new periodontal ligament attachment to the root surface in the absence of long junctional epithelium.”
FDA clearance for Laser-ANAP® using the PerioLase® MVP-7™ variable pulsed Nd:YAG dental laser follows three years of research at Louisiana State University, School of Dentistry, New Orleans, by principal investigator, Professor Raymond A. Yukna, DMD, MS, and coordinator of post-graduate periodontics at LSU. Professor Yukna led a controlled, blinded, clinical and human histology study that evidenced new root surface coating (cementum) and new connective tissue (periodontal ligament) formation (collagen) on on tooth roots by stimulating existing stem cells to grow following the use of the PerioLase® MVP-7™ & Laser-ANAP® protocol.
“These results are very positive, very consistent, and very encouraging related to the treatment of deep gum pockets,” said Yukna. “Dentists have been looking for ways to regenerate some of the tissues lost to gum infections and Laser-ANAP® is an exciting and revolutionary treatment protocol showing microscopically that we can form a new root coating (cementum) and new connective tissue attachment (collagen). Our consistent results (all LANAP treated teeth showed a positive result) suggest that the best possible type of healing can be obtained using the specific Laser-ANAP® protocol. This presents a wonderful alternative to traditional surgery.”
The preliminary phase of Yukna’s study was published in the International Association of Dental Research, January, 2004. On March 12, 2004, Dr. Yukna and co-workers presented their complete findings at the International Association of Dental Research Meeting in Hawaii in a paper titled, “Human Periodontal Regeneration Following the Laser Assisted New Attachment Procedure.”
http://iadr.confex.com/iadr/2004Hawaii/techprogram/abstract_47642.htm
Contact Info
Paxton Quigley
818-986-4502
paxq@aol.com
MDT Public RelationsDr. Ray Yukna, Professor
LSU Grad Periodontics
(504) 619-8659
PerioRay@aol.comDr. Delwin McCarthy, COO of MDT
562-860-2908
dmccarthy@millenniumdental.comRelated Links
http://www.millenniumdental.com
IADR Abstract – Dr. Yukna’s Human Histology Study
Dentists provide laser treatments and avoid using a scalpel
Human Periodontal Ligament Stem Cells Isolated for the First Time
Laser Your Gum Disease
It’s NOT your dad’s dental laser
Glenn van AsSpectatorCongrats Bob and Del on gaining the new FDA for the laser procedure. I know that you have worked very very hard for this in getting cleared.
I hope that this clearance becomes another avenue for the companies success and look forward to the eventual introduction of the Periolase into Canada.
Glenn
lagunabbSpectatorcongrats
whitertthSpectatorAs they say in the Mother Tongue, Mazel Tov…We are all proud of u guys….
SwpmnSpectatorCongrats to Delwin and Robert on the accomplishment. Rusty Schaeffer alerted me earlier this month that something new was on its way!!!!!
Al
whitertthSpectatorBob,
Once again my sincere congratulations. I have a question, and I man this as question no anything negative. As a lecturer I’m sure u get asked by the position of the AAP….How do u answer that. We all know the AAP does not really recognize the procedure as an accepted modality to treat Perio. What would happen if a patient brought on legal action agaginst a DDS who used the periolase, followed proper protocol and didnt get results as expected? Do u think the AAP will alter their position based on the new FDA approval.?
Many questions but very interested.Warmest regards,
ASISpectatorCongrats, Bob & Del.
Another significant step along the way to broaden the acceptance of the Periolase in the treatment of perio.
Now, they are taking notice after just ignoring and then laughing.
Best wishes,
Andrew
Robert Gregg DDSSpectatorThanks Everyone for the kind words and kudos.
It is much appreciated.
Ron has excellent questions about the AAP. I have a long answer in my training and lecture slides but it goes pretty much like this.
1. The AAP Statement on Laser “ENAP”, made hastily in August of 1999, regarded a procedure with a different name and history. This statement is now 5 years out-of-date. Most of the periodontists I speak with understand this.
2. FDA suggested we change the name to Laser “ANAP” by substituting “assisted” for “excisional”. That way we could create and develop our own data, science and results tied to a brand new procedure with a brand new name. Great suggestion.
3. LSU and Prof Yukna did the 3rd largest human histology study ever when they sectioned 6 LANAP teeth and 6 S/RP teeth en bloc. 6 of 6 LANAP teeth showed NA. None of the S/RP showed any NA–only long JE.
4. Now that FDA has cleared Laser ANAP, there is no longer any concerns over using the procedure–not that there really ever was. That was part of the goal we were going after. It’s why certain people are so frustrated that they say ridiculous things like there are no studies that show NA is any better than JE!
5. State Board recognizes FDA clearance and the procedure has university based science to back it up.
6. There is presently no surgical/scalpel perio procedure like APFs, or modified Widman flap, etc that have gained specific FDA clearance. Certain materials and bone grafts have FDA clearance, but that is not a specific surgical procedure–they are considered “devices” by the FDA, like the PerioLase is a device. So that might help a legal issue if it were to go that far.
7. Our results that will be published this month in General Dentistry, the AGD’s peer reviewed journal compare LANAP to other surgical procedures. The results show that LANAP is predictable and reproducible between doctors practicing LANAP and patients who have received LANAP treatment. All without any recession.
So there is solid university human histological science, very language specific FDA clearance, outstanding clinical results published in a peer reviewed journal that show the excellent results of LANAP. Does conventional perio surgery have all that? No, not at all.
Finally, in 14 years, I have never been threaten with a lawsuit for using a laser for anything, let alone LANAP. And that’s why we have 3 days of Laser BootCamp before we ship the PerioLase. To make sure no one will cause an injury that could lead to a lawsuit.
We are going to see the AAP–as a political organization–change very slowly. But they will eventually. But they will change quietly and w/o fanfare. Some of their previous position papers on, for example, antimicrobial irrigation were silently and uncerimoniously deleted from the AAP website recently.
We have already seen a 180 degree change in the reaction of the “rank and file” AAP members when we were at their meeting last year. I suspect in a few weeks at the AAP meeting in Orlando, we will see further progress and acceptance, as well as a few that just can’t get comfortable with the idea. Oh well, that’s Life.
Change is inevitable. I just can’t believe the technology that we all face every day in the consumer world. My wife just got an iPOD. WOW! What incredible sound and so many recording in a little device.
The more we “push the ball down the field”, the more we continue to conduct research, the more AAP folks will come to realize their previous “positions” need to be re-evaluated.
Thanks again for the kind words and support.
Our best to all,
Bob
BNelsonSpectatorFantastic, Bob and Del. I knew it was coming and it is really exciting it is here. Did my first LANAP interview for TV today. The health reporters were very interested, so I believe things are going to start moving very fast!
Congrats again!
Kenneth LukSpectatorBob,
Excellent news!
Last week, I went to an Advanced Periosurgery course. The speaker ( Dr. Hom Lay Wang from University of Michigan )brush lightly on the use of lasers for perio. Not very encouraging comments obviously. He said he will be working with Ray Yukna on more researh projects. I suppose he would be seeing the Periolase first hand. I’ll be going to his course again in Jan and March next yr. He may change his mind?
Congratulations once again to you and Del.
You know I’m still saving up for your Periolase!
Ken
Robert Gregg DDSSpectatorThanks Ken,
I was with Dr Yukna last weekend in Colorado at the Columbine Perio Study Club for his lecture on regeneration methods and materials.
We discussed upcoming research with LANAP in a multi-centered clinical trial, but Dr. Wang was not mentioned. Maybe they work on other regeneration projects. If Dr. Wang is in contact with Ray, then he needs to ask about LANAP cuz Ray is pretty excited about it.
Thanks,
Bob
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