Hi Mickey,

Kenneth Luk will be the first to test it at the end of October !

Olaf

(Edited by spider24 at 2:05 pm on Oct. 8, 2004)

Mickey,

I’d like to see a defined protocol and some safety studies before putting a 20,000 Hz diode into a pocket blind to treat perio.

I’m very concerned about any company that allows any doctor to “test” their laser w/o any training, or protocols or clinical science. Who has done research on this device and what are the parameters of operation? Who did the research and who has validated it?

Who is going to “test” the laser on? Patients? What happens if the “testing” goes wrong?

Ask the company for the science it has used to arrive at safe and effective parameters of care. Clinicians should not be put in the positiion of doing the company’s clinical research. That attitude has hurt–severely–a lot of pateints over the years. This is the company’s responsibility, not the willing dentists in the marketplace.

Your patients deserve it.

We are 15-20 years beyond the start of lasers in dentistry. There’ no excuse to skip clinical R&D.

Bob

Olaf,

No need to be defensive. I made no judgements. Nor am I am not trying to chase you off this board.

But you must understand that this board has some pretty sophisticated laser users who want more than just marketing claims from any company, or “drive by” drop offs of lasers for patient “testing”, or the testing of a device thought up in an engineer’s lab w/o proper clinical research.

I only asked questions regarding the understanding of the clinicians who would use any product w/o specific training and/or science.

That´s the reason why me made and make studies at the Universities of Freiburg, Mailand and Vienna. The oldest studies are now running for 6 years. The oldest with 20 W / 10.000 Hz are from 1999. The new 30 W / 20.000 Hz unit is used for nearly one year at the RWTH Aachen, Univeritiy of Freiburg, Milano and Vienna.

I think we would all like to see the results of your studies. 6 years is a long time to run a study, by the way. What parameters of clinical or research outcomes were you looking at? You are welcome to post any and all, as this group would like to see it.

If we offer “tests” with our devices the testing includes everytime a peronal laser safety instruction, technical and clinical instruction which takes about 4-8 hours depending on the skill of the operator. Not in a course with 10 other dentists.

OK, who does the training, a dentist or a sales rep?

Additionally, i have to say that we have the highest level of certification at elexxion (ISO 9001, EN 13485) and the highest level of technical and clinical certification to the laser unit which includes medical compliance testing.

You are talking about device manufacturing and Good Manufacturing Practices (“GMP” ) compliance. That’s great you have those certifications, but what does that have to do with the safety of patients when doctors are using your lasers w/o known clinical parameters?

You can´t work with wrong power settings because every possible application is named and has fixed power parameters which only can be changed +/- 30 %.

A clincian cannot apply the “right” clinical parameters if:

1. They don’t know what energy parameters they are using such that they can make intra-operative adjustments.
2. They do not know the energy at the fiber tip–unless it’s a “hot glass” effect.
3. The laser they are using has a variance of +/- 30% which is HUGE unless there are compensating conditions–like fiber “conditioning”.

So what´s the problem ?

Nothing as long as you:

1. Present your science to back up your marketing claims.
2. Show data on safety and efficacy using your new parameters for the procedures you want dentists to test.
3. Train dentist thoroughly in the use of this new device parameters, before letting them experiment on live patients.

Ok, i stop offering tests of elexxion products in this forum because i don´t want to make marketing for our products.

Perhaps a good idea in the absence of addressing the concerns I listed above.

Bob

All studies which are made until now are published in German language. But i post everything we get in english in the future.

One thing is very important: With the elexxion claros we are not talking about a protoype or something which has just left the lab !

There are ~ 400 units with 20W / 10.000 Hz and ~ 150 units with 30 W / 20.000 Hz which are succsessfull used in dental offices all over euope and asia for several years now.

“Testing” does NOT mean that any dentist should test if clinical parameters or treatment protocols are working. That was done at Universities years before. Due to the European law you have to show the evidence that our treatment protocols are right. But that documentation is not public.

“Testing” means to work a while with a well known unit to get an impression of the handling and the features.

We do not make any experiments with dentists or patients !

All energy parameters are clearly shown on the display. And an internal calibration system measures the output power continueisly. When there are differences more than 10 % between the real output power and the displayed power the laser will switch off with an error message. Intra-operative adjustment is possible with +/- 30 % from the original value to compensate power changes due to fiber conditions.

Olaf

6 months or so have passed since the last post – Has Elexxion yet provided copies of their published studies?

Sorry, the results are not published until now – but it will be very intersesting. I´ll keep you informed.

olaf