Forums › Nd:YAG lasers › General Nd:YAG Forum › First Laser Gum Disease Procedure to gain FDA Clearance
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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 This statement is now 5 years out-of-date.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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