Nobel Responds to Dental Implant Critics
Posted in Dental Implant News Nobel Biocare
« One-Piece Dental Implant – Abutment Units | Filling the Screw Channel »
Subscribe to this PostDo you think there will be any major repercussions from the recent Nobel Direct dental implant saga, which heated up this past week?
As you may already know, two professors, Tomas Albrektsson and Lars Sennerby, had issued allegations concerning Nobel Biocare’s dental implant NobelDirect back in May 2005. This seemed somewhat innocuous. However, last Tuesday, Par-Olov Ostman, a Swedish dentist, said his clinic would withdraw from Nobel study, which the company is conducting to monitor the Nobel Direct dental implant.
The reason for Ostman´s withdrawal? Ostman’s clinic had reported that over 30 percent of the dental implants were
accompanied by more than 2 millimeters of bone loss during the first
year. Ostman said six implants had had to be removed due to bone loss. “Nobel keeps telling television and newspapers that there’s nothing unusual about this implant, and I cannot agree with that,” Ostman told Reuters.
Nobel was quick to fight back against this recent accusation. According to the company, “The information is anecdotic; there are no indications of this material being part of a systematic review and by no means as complete as requested. They contain no scientifically or statistically relevant evidence supporting the allegations.” With regards to Ostman´s dental implant findings, Nobel was quick to point out that Ostman has a strong professional relationship with Tomas Albrektsson and Lars Sennerby and more importantly, “the performance of Dr. Oestman’s implants is significantly below the average performance of the other participants of the studies.” Finally, Nobel reiterated that based on clinical studies the NobelDirect dental implant, ” is a safe and reliable product.” “Since the Swedish Medical Products Agency is investigating these allegations upon Nobel Biocare’s request and since Nobel Biocare fully supports and trusts the Agency’s procedures, the Company expects the opinion by the Agency.”
Interestingly, the Nobel Direct dental implant accounted for only 2 percent of Nobel´s sales, so the economic impact to Nobel should be limited. However, the key question is whether there will be any impact from this on the marketability of other Nobel dental implant product lines. What are your thoughts?
Seems many are bashing Nobel but as a young practitioner I respect those who have the experience. I recently spoke to a prosthodontist from South Jersey who has placed AND restored over 10,000 implants. He switched from Zimmer to Nobel and is quite happy with his results. I plan on buying Nobel’s system because I also believe it to be a quality product.
I think that a Nobel Direct implant is just a Replace implant whith an attached abutment. I cannot understand how could develop more problems that a implant and a healing abutment. Perhaps oclussion factors?. Perhaps excessive heat meanwhile preparation?
RESPONSE TO:
Dr. Niznick you are the Implant Direct rep so why should we rely on what you tell us about research?
ANSWER:
I am not generating studies or articles to support the sale of my products… I only pointed out that the articles you cited are anecdotal, written by company funded lecturers and published in non-peer reviewed journals.
RESPONSE TO:
You are arguing from a commodity based marketing viewpoint while others disagree and argue from a value added stand point. Is it of value to decrease healing times for restorative options when one can not do immediate load? You argue no. But then your not selling the solution to the patient who doesn’t want to wear a flipper for an extra two months or a Referring Doctor who wants to place the crown as soon as possible.
ANSWER: Companies like 3i argue that their value added feature is platform switching reducing bone loss, but there is no credible research to back that up, so what value are they adding for their $300+ implant. I offer platform switching options as well but I don’t tell you that it will provide any benefits. Companies like Straumann claim that using their new surface SLActive will shorten healing time but again they can not prove this to justify the extra $50 they charge. As for my not offering the solution to shortenning healing time, the fact is that in type 1 and 2 bone quality, where initial torque of 35Ncm can routinely be achieved with any screw implant, a dentist can do immediate provisional load and eliminate the flipper right away. In type 4 bone it can not be achieved with any implant design and full healing period should be observed. Where my products offer an advantage in shortening the time to loading, over companies like Straumann, is in type 3 bone where the soft bone surgical protocol of inserting a tapered implant into an undersized socket prepared with a straight drill, may allow achievement of the required initial stability (35Ncm)for immediate load, whereas a Straumann implant will be hoping that with its SLA surface it can be loaded in 4-6 weeks – So I offer a solution that beats that time and it is available for 74% less than Straumann.
RESPONSE TO:
I think most people understand that you want to provide a commodity option from a price point view and that you have bias along with your knowledge, creativity and experience in the dental implant world.
ANSWER: Good – then I am getting my message through, but I am offering, along with low prices, the highest quality, most innovative implants in the industry, with alll-in-on packaging for ease of ordering and convenience of use. I am betting on the intelligence of dental professionals to see through the BS of the high priced implant companies, their paid opinion leaders and sales people who just repeat what the company line is to sell their products at a high price.
FROM A NEW IMPLANT DENTIST
Response to:
I recently spoke to a prosthodontist from South Jersey who has placed AND restored over 10,000 implants. He switched from Zimmer to Nobel and is quite happy with his results.
I know who you are talking about and he switched because Nobel gave him hundreds of thousands of dollars to build his implant training center and Zimmer refused to give him that money. He gets about a 40% discount which you will not get as a new user. High Prices and endorsements from paid opinion leaders are not good reasons to chose a system. Implant Direct makes an implant called the RePlant, a surgically and prosthetically compatible implant to Nobel Replace Implant and sells it for 1/3rd the price. We make it out of alloy rather than CP titanium that Nobel has to use because TiUnite does not bond to alloy (their HA coated implant uses alloy.) Even using the stronger material, this design is subject to breakage because the cross-section of the tri-lobe is greater than an internal hex, leaving the walls of the 3.5mmD and 4.3mmD implants very thin. I have made another implant with the Tri-Lobe connection called the RePlus, using the 3.7mmD and 4.7mmD body design of the other Spectra-System implants I make, thus increasing the wall thickness by 44% and 66% respectively.
As for Nobel Bashing, the Swedish Medical Products Agency just came out with its final report on the bone loss associated with the NobelDirect and NobelPerfect implants. It will be posted on Monday under the Controversies section of my web site http://www.implantdirect.com While they did not ask for a recall of the product, they were very critical of Nobel’s marketing claims and required that Nobel provide adequate warnings on the labeling of these products. No need to do Nobel Bashing when the Swedish Medical Products Agency is doing for the industry.
Jerry Niznick would make a good car salesman.
Comment from some no-name posting: Jerry Niznick would make a good car salesman.
Response: It is always interesting to post a blog and then try to figure out which implant company’s salesman got his feathers ruffled and responds with a cheap shot. Nothing wrong with a car salesman, especially if he is good. The same goes for an implant manufacturer, as long as he makes a high quality product that meets the needs of dental profiessionals at a price that leave the competitors only throwing spitballs like this Nobel salesperson.
hi jerry, can i ask roughly when your implants will receive ce approval and you will sell to the uk.thanks.
Dr. Niznick,
1. I did not list any articles, and you may be projecting your own bias on to the research of others. Not all researchers sell an answer to the highest bidder. Most report exactly what they find, and most people can determine if a study was designed well to provide useful information.
2. You then declare that your tapered implant is better than a Straumann implant in class 3 bone. Where is the proof? Are we to take your word for it? Will your next response have clear research comparing your tapered implant to the Straumann TE or will it be more of the same. My understanding of SLA is 6-8 weeks healing in good bone without a torque requirement of 35newtons at placement. No backing the implant up to get the tri-lob in the right place or going deeper than intended to reach the 35newton requirement. But again, where is the evidence, and it must include the hybrid design from Straumann and not just tapered vs. conical? Otherwise you are just delivering a marketing message. You always fall back to an immediate load conversation as if 95% of cases are candidates for immediates. But given that you do not intend to spend money educating the marketplace how will you change the reality where a vast majority of cases are delayed.
3. In your final post you again make points about another companies design weakness stating what appear to be facts. Where is the research? And even if you did the research haven’t you allready stated that all company research is bought and paid for to come to the desired conclusion. So even if you did research with claims of failure due to wall thickness how do you differentiate yourself from the New York dentist who you hammered.
You constantly deliver your opinions as if they are undisputed facts. In most instances they are just your opinions. When you try to quote a fact you undermine your own arguement by calling all company sponsored research garbage. Which is it? Good factual research on immediates or company marketing information dressed up as research? You can’t have it both ways.
As for something being cheaper, that is not the first thought that comes to my mind when I think of implantable devices.
I’m amazed Nobel have got off with barely a slap on the wrist. I remember when NobelDirect was launched it was billed as the answer for new GP surgeons – flapless surgery, single stage, so easy even a four year old could do it.
Now they’re being told they have to change this to recommend its use only in experienced hands.
Now they’re telling us that “groovy” implants are better based on one rabbit study. When will that shoe drop?
I refuse to to any further business with Nobel until the science backs the claims.
QUESTION FROM mpWILLIAMS: jerry, can i ask roughly when your implants will receive ce approval and you will sell to the uk.thanks.
ANSWER: We passed our iso audit and should have ce approval by January.
NIZNICK’S RESPONSE TO ANOTHER NO NAME POSTING
STATEMENT: Not all researchers sell an answer to the highest bidder. Most report exactly what they find, and most people can determine if a study was designed well to provide useful information.
NIZNICK RESPONSE: I GUESS THAT IS YOUR OPPINION OR DO YOU HAVE RESEARCH TO BACK UP YOUR CLAIMS ABOUT RESEARCH?
STATEMENT: You then declare that your tapered implant is better than a Straumann implant in class 3 bone. Where is the proof? Are we to take your word for it?
NIZNICK RESPONSE: YOU DO NOT HAVE TO TAKE MY WORD. THE RESEARCH SHOWS THAT INSERTING A TAPERED IMPLANT INTO AN UNDERSIZED SOCKET IN SOFT BONE RESULTS IN INCREASED INITIAL TORQUE, INCREASED REMOVAL TORQUE AND INCREASED % OF BONE CONTACT. THIS WAS PROVEN IN AN ARTICLE BY SHALABI COIR MAY 2006. If an implant can gain increased initial stability in soft bone, to achieve 35Ncm then it can be loaded immediately. Even if it is not loaded because it falls short of this target, the increased initial stability and bone attachment translates into
the same type of claims Straumann is making with its SLActive surface. (this article has been reprinted in on http://www.implantdirect.com > about us > libary.
STATEMENT: My understanding of SLA is 6-8 weeks healing in good bone without a torque requirement of 35newtons at placement.
NIZNNICK RESPONSE: NOTHING UNUSUAL HERE…YOU CAN DO THAT WITH ANY ROUGH SURFACE…EVEN A SMOOTH ONE LIKE OSSEOTITE HAS DEMONSTRATED SUCCESS AT 6 WEEKS LOADING.
STATEMENT: You always fall back to an immediate load conversation as if 95% of cases are candidates for immediates.
NIZNICK RESPONSE: :YOU MISS THE POINT… IF AN IMPLANT CAN BE IMMEDIATELY LOADED AND BE SUCCESSFUL, THEN IT CAN LOADED IN 6 WEEKS AND ALSO BE SUCCESSFUL. THE CONVERSE IS NOT ALWAYS TRUE.
QUESTION: But given that you do not intend to spend money educating the marketplace how will you change the reality where a vast majority of cases are delayed?
NIZNICK ANSWER: AGAIN YOU MISS THE POINT. I DON’T CARE IF THE IMPLANT IS LOADED IMMEDIATELY OR IN 4 MONTHS…BUT IF THE ARGUMENT IS ABOUT WHAT SURFACE OR BODY DESIGN OR SURGICAL PROTOCOL CAN BE LOAD EARLIEST, THEN THE IMPLANT THAT CAN BE LOADED IMMEDIATELY IN SOFT BONE MUST WIN, AND NEITHER NOBEL OR STRAUMANN ARE MAKING THAT CLAIM.
QUESTION: In your final post you again make points about another companies design weakness stating what appear to be facts. Where is the research?
ANSWER: ALL I DID WAS SIGHT THE SWEDISH PRODUCT AGENCY’S REPORT WHICH REPROTED ON STUDIES BRINGING INTO QUESTION NOBEL’S STUDIES AND CERTAINLY THEIR CLAIMS. WHERE INDEED IS THE RESEARCH TO SUPPORT NOBEL’S CLAIMS ABOUT ITS NOBEL DIRECT AND NOBEL PERFECT IMPLANTS.
QUESTION: You constantly deliver your opinions as if they are undisputed facts. In most instances they are just your opinions. When you try to quote a fact you undermine your own argument by calling all company sponsored research garbage. Which is it? Good factual research on immediates or company marketing information dressed up as research? You can’t have it both ways.
ANSWER: YOUR LOGIC ESCAPES ME. YES I AM EXPRESSING MY OPPINION FOR WHATEVER WEIGHT THAT CARRIES. NO I AM NOT SAYING THAT ALL RESEARCH IS GARBAGE BUT AS FAR AS I CAN SEE, THE RESEARCH SPONSORED BY THE IMPLANT COMPANIES SERVES PRIMARILY TO CREATE MARKETING MATERIALS AND PROVE VERY LITTLE WITH REGARD TO REAL CLINICAL ADVANTAGES.
QUESTION: As for something being cheaper, that is not the first thought that comes to my mind when I think of implantable devices.
ANSWER: NOR SHOULD IT BE. I ASKED A DOCTOR WHY HE SWITCHED TO MY NEW SYSTEM AND HE LISTED 5 REASONS IN DECENDING ORDER OF IMPORTANCE.
I am currently using both Astra and Nobel Biocare Replace Select. The majority of implants I have placed in the last two years have been Astra. The decision factors I used in my decision to make the switch are (in order of importance):
1) Quality of manufacturing (based upon your historical record),
2) Internal hex connection (I have not really liked the tri-lobe connection of Replace Select nor the butt joint type of connection fit of the analog),
3) Cost of implants and abutments,
4) Simplicity of design in the abutment/impression post (simplicity tends to be overlooked – thanks for the innovation),
5) Ease of ordering (i.e., online ordering with live support if needed).
You’re right that your new system will be difficult for major companies to deal with, not only with price but also with the simplicity of abutment design. Included a fixture mount that can be the impression post and direct abutment is outstanding. If you were a public company, I’d certainly buy stock.
what kind of abutment to implant connection is there on your implant, is it a conus type like astra?
The RePlant and RePlus implants from Implant Direct have a flat top with a tri-lobe connection that is compatible with Nobel’s abutments. The ScrewPlant and ScrewPlus have an external bevel and the Legacy has an internal bevel. We are achieving precision fits with less than 1/2 degree of rotation which means that you can not even fell rotational movement between the parts. I think the connection with the external bevel offers the greatest strength, stability and prosthetic versitility.
thanks dr niznick, i am concerned about screw lossening and bacteria leakage at the ia interface. also astra has a long cone type connector to move loads down the implant. thanks for any information.
Two peices of metal can only make contact at 3 points at a time. There is no magic to a conical connection vs a beveled connection vs a butt joint connection with regard to achieving a sealed margin. Microleakage comes from an unstable connection and the connical conection of Astra or Straumann are no different than an internal hex or tri-lobe connection in that they all are capable of achieving good stability, depending on how close the machining tollerances are. I make a tri-lobe butt joint, an internal and an external bevels with hex connecitions and all of them are machined to tollerances that achieve less than 1/2 degree of rotational wobble. This is in contrast to the external hex Branemark Implant which was documented in a Binon article to have 6.7 degrees of wobble. With an external hex, the fixation screw takes the stress and when you couple that with a sloppy fit, you get micro-leakage. Any of the common internal connections on the market can eliminate any clinical significant problem if their tollerances are good. Companies like Astra were more stable than Nobel and therefore used this as a marketing claim but this advantage it does not apply to other internal connections which are just as stable. The problem with Astra’s connection is that you can not use the internal double hex for screwing the implant into the bone because it is too close to being a circle. Don’t fall into a company’s marketing claims.
The last posting was mine although my name did not register
I stumbled across this site while trying to do some research. My wife went yesterday to have her permenant crown installed on her implant (no we don’t know the brand, as lowly laypersons we were never made aware of the fact that there are different brands). During the procedure, she was told “the screw broke and they can’t get it out, so it looks like she may have to start all over again” Wow, I wonder who gets to pay for that? I felt that I needed to respond to this site since I have learned a great deal about the dental implant business. Thanks to the couple of posters that actually sounded like there may still be some concern for the patient and not just the bottom line.