Buser Exchange for Newsletter

Email exchange regarding Implant Direct’s SwishPlus Straumann Compatible Implant Dr. Daniel Buser, President of ITI and Dr. Gerald Niznick, President of Implant Direct Subject: So what do you think of this video?

Date: 9/8/2012 3:25:02 P.M. Pacific Daylight Time From: Niznick@aol.com To: daniel.buser@zmk.unibe.ch

http://www.youtube.com/watch?v=-rpGll2-fRs&feature=youtu.be

Jerry Niznick DMD, MSD President and CEO Implant Direct International www.implantdirect.com Subject: Re: So what do you think of this video?

Date: 9/9/2012 2:48:55 A.M. Pacific Daylight Time From: daniel.buser@zmk.unibe.ch Reply To: Niznick@aol.com

Dear Jerry Thanks for the commercial video. As you know, marketing material has never impressed me, since I believe in evidence provided by good research.

On the other hand, I want to give you a fair chance to convince me that you are a serious guy. Thus, could you please provide any meaningful clinical 5-year study in a reputable journal with a review process on your implants to substantiate all the claims. In addition, I would love to see any preclinical research on your implant surface, since I was always engaged in research of surface technology.

Thus, this would be most interesting to me as well.

Best regards Danny Prof. Dr. Daniel Buser Chairman Department of Oral Surgery and Stomatology School of Dental Medicine University of Bern Freiburgstrasse 7, CH-3010 Bern

Subject: Re: So what do you think of this video?

Date: 9/11/2012 8:30:00 A.M. Pacific Daylight Time From: Niznick@aol.com Reply To: daniel.buser@zmk.unibe.ch

Dan, Your response convinces me that you are not "a serious guy" when it comes to evaluating implans from companies that you do not derive income from. Seeing is believing when it comes to better packaging, thread design improvements and self-tapping features. Raising the height of the blasted neck of the SwishPlus (to preserve crestal bone ) is supported by research...yours.

The Effect of a Machined Collar on Bone Loss: A.N. Alomrani, J.S.Hermann, A.A. Jones, D Buser JOMI 2005;20:677-686 RESULTS: Fifty-eight of the implants integrated and were analyzed on each proximal surface. Bone loss occurred around all implants over the 6 months of the study. In general, implants placed with the top of the SLA surface above the bone crest had significantly less bone loss than implants with the top of the SLA surface placed flush with the bone level. Apically placed implants had greater bone loss than coronally placed implants.

The magnitude of bone loss around paired control and test implants was approximately the same.

DISCUSSION AND CONCLUSION: The least bone loss with each implant type was observed when the top of the implant was placed above the alveolar crest. When there was no machined collar, the least distance from the implant top to the bone crest (not, however, the least bone loss) was observed when the top of the implant was level with the bone crest.

As a clinician, you know you would love to have a product with the features of the SwishPlus instead of the straight, non selftapping implant with minimal thread engagement that the ITI group teaches for Straumann. You have a long history promoting whatever surface Straumann is putting on its implants, including TPS that is now off the market, SLA and the more expensive SLActive, which has not demonstrated any clinical advantages for the extra $50 it cost. That is because the issue is not how much torque it takes to remove an implant in the 3rd-4th week (graphs on right), but how much initial stability can be achieved. As you can see from the charts from Zimmer Dental’s Website on the next page, the Tapered ScrewVent, which I developed in 1999 and updated with Implant Direct’s Legacy line, achieved very high clinical success over a 10 year period and twice the initial stability of Straumann’s straight, tissue level implant (119.9Ncm vs 60.5Ncm). Initial stability is critical to allowing immediate load with implants. You certainly would not want to load a Straumann implant with SLActive surface 3-4 weeks after insertion, when stability has decreased, if the implant did not achieve adequate initial stability for immediate load. The graphs from the SLA/SLActive studies demonstrate that by 6 weeks, both surface treatments reach 100% of initial torque values. Straumann’s claims of superior bone response to SLActive or it’s Roxolid titanium alloy, have not been shown to have any clinical significance.

There are many preclinical studies proving the efficency of Implant Direct’s SBM (Soluble Blast Media - HA blast) and HA coated surfaces. These studies document a higher % of bone contact with SBM & HA surfaces compared to TPS, Acid Etched or Machined surfaces. A torque removal study at LSU University showed similar values for SBM, HA and TPS surfaces at 1 month but HA had almost doubled by 2 months. There are many published studies over the last 20 years documenting high clinical success with implants I developed including.

10 Screw-Vent studies on Zimmer Dental’s website (see next page). Implant Direct’s website library contains links to the VA Study that included1875 HA Implants - 96+% success and 3 recent studies with 98-100% success.

Your own 1991 study* showed a higher percentage Buser et al. of bone contact with HA coated surfaces compared Mean Percentage of Direct Bone Contact of Difference to SLA and TPS, but your conclusions discounted Implant Surfaces at 3 and 6 Weeks HA based on a finding that the HA resorbed with time. The HA tested was on IMZ implants and per your report, exhibited only 20% crystallinity. The HA coatings used by the American companies, CoreVent and Calcitek (now Zimmer Dental), provided 85%+ crystallinity, eliminating the resorption issue.

You never explored the HA advantages further bringing into question how serious you were in finding the best surface once Straumann had its “unique surface” for marketing, falsely claiming that the time to load with SLA was half that of TPS. *Buser et Al.: Influence of surface characteristics on bone integration of titanium implants.A histomorphometric study in miniature pigs. Journal of Biomedical Materials Research, Vol. 25, 889-902 (1991) 0 1991 John Wiley & Sons.

Below are 10 clinical studies documenting very high success rates with SBM and HA coated Screw-Vent Implants now sold

by Zimmer Dental. More are listed on Implant Direct’s web site.

Implant Direct’s Implants evolved from my earlier Screw-Vent designs and use the surfaces, materials and surgical protocols.

By using HA particles as a soluble blast media (SBM) the need for acid etching is eliminated, thus preserving the sharpness of the threads and cutting grooves. In 20 years, I have not seen the need to change. Straumann during that period, has gone from TPS to SLA to SLActive with no clinical studies showing any significant improvements although the costs certainly rose with each surface change. The chart on the lower right documents a high initial stability with the Tapered Screw-Vent and the lowe left picture shows the Legacy3 updated version of my earlier design. The SwishPlant and SwishPlus also incorporate these design improvements in order to achieve higher initial stability essential for success in soft bone and immediate load.

Legacy3 System from Implant Direct Evolution of the Tapered Screw-Vent Implant

May 19, 2012 Translated from Swiss Swiss Business Periodical Finanz & Wirtschaft, responding to Straumann’s entrance into the low priced implant market ... ”there is the question if premium manufacturer Straumann is betraying its own ideals if , as announced this week, it is exploring its luck with lower priced products in emerging markets.?

How will dentists react?

Through the engagement with in Neodent, where Straumann can raise its shares up to 100% in the next six years, the company from Basel, Switzerland steps into the bulk business for the first time.

Straumann acknowledges (Neodent’s) lower standards in product quality (empirically, lower priced implants have to be replaced more often than premium products) during an investor conference in Amsterdam by President Gilbert Ackermann and CEO Beat Spalinger. Despite separate brand management (between Straumann and NeoDent products) dentists and patients could start to think that the products are replaceable which would destroy the reputation as the quality leader in the implant market which Straumann built carefully in the last few years.”

Below are pictures of Straumann's latest product acquisition, NeoDent, in comparison to Implant Direct's and Nobel Biocare’s products. These pictures demonstrate that the price charged by implant companies is not directly related to the quality, precision and value of the implant or the intelligence of the design. Implant Direct competes with Premium Priced companies such as Straumann, Nobel Biocare, Zimmer Dental and Astra by offering quality, innovation, customer service and VALUE. Contrary to claims by Straumann, as demonstrated in this document, company funded research and high prices are no assurance of superior design, quality or clinical success.

NeoDent Internal with Stained Platform $60-$80 with cover screw

Implant Direct Legacy1 Internal Hex $125 with Cover Screw & Healing Collar

Micro-Threads Implant/Abutment Precision Interface

SBM Surface Implant Direct RePlant $150 includes CS, Transfer, Temporary Abutment

NobelActive Implant with Ti. Burrs on Top $399 without cover screw