| SECTION 4 – THE COMPETITION
Friadent User: I would check out the Frialet (Friadent) system. It is fantastic. I have used this for immediate tooth replacement for almost a year. I have not been disappointed. Dr. Niznick:
Paragon recently licensed Friadent to use our internal hex patent. So
I can't say anything negative about the connection. I would suggest
that you look at the abutments, though. They have shoulders on them,
which come in different cuff heights. This adds to the selection process
and prevents attachment of the abutment in place of a healing collar
to hold the tissue back without also making a provisional prosthesis.
Friadent's angled abutment has the shoulder high on the labial and low
on the lingual, the exact opposite of what a natural preparation would
be. This means that excessive grinding is needed on the labial and the
lingual margin is too far below the tissue to allow attachment directly
in the mouth for conventional impressions. All preparation needs to
be on the stone case. Check out the following link showing this abutment:
Q: Thank you for forwarding me the exchange of comments on immediate loading. The following comments from Sargon point out that they are trying to find a mechanical solution to a biological problem. If a "screw" does not work in a wall you use a "molly bolt." How much research do you need to prove that? It is amazing to me how patients quickly understand the mechanics of the Sargon implant and how much difficulty some doctors have seeing it.
A: Getting osseointegration to occur while subjecting the implant to some degree of micro-movement by immediate loading is a complex issue. Several factors contribute to achieving clinical success when subjecting an implant to immediate load. These include: 1. Density of the bone—the denser the bone, the more likely for success. 2. Initial stability of the implant based on design—the result of self-tapping threads and bone compression by placing a tapered implant into a straight hole. The AdVent implant from Paragon offers these features and Paragon has the patent on this method of insertion. 3. Surface roughness of the implant—Paragon's SBM-blasted surface demonstrated 64% bone contact compared to 56% for TPS in an immediate load animal study. HA may even be better because of faster integration. If the implant is overloaded in the first few weeks,however, faster integration with HA (within 6 weeks) may not be a factor. 4. Surface area of the implant—Thread design can be a factor in the implant's ability to distribute load and minimize micromovements that can interfere with achieving osseointegration. Self-tapping threads, preferably with more depth between the inside and outside dimensions than with the standard Branemark V-shaped threads, could also contribute to increased initial stability and load distribution within physiological limits. 5. Splinting of implants - especially across the mid-line of the arch, will reduce the micromovements the implant is subjected to and therefore increase chance to achieve osseointegration following immediate loading. 6. Design of the prosthesis -- splinting the temporary crown on a single tooth implant replacement to adjacent teeth and keeping the crown out of occlusion will contribute to success. How does the Sargon Implant design stand up to these factors? 1. not self-tapping 2. standard V-shaped threads 3. relatively smooth surface 4. can compress bone by expanding the implant's pods, but at the expense of weakening the implant and creating a potential trifurcation or future fracture problem. LETS NOT FORGET THAT SARGON JUST HAS AN EXTERNAL HEX THAT CAN LEAD TO FUTURE PROSTHETIC STABILITY PROBLEMS. Nobel Biocare/Steri-Oss (Replace Select implant) and ITI (synOcta implant) have now introduced internal connections. Nobel Biocare's new marketing ad states that the Replace Select implant gives "what every doctor wants...an internal connection." So, what have they been pushing for the last two decades? What every (discerning) dentist doesn't want...an external hex implant! Paragon has initiated patent infringement proceedings against Nobel Biocare, Straumann and Friadent. All these companies, along with 3i, Calcitek and Lifecore who had to remove their internal connection implants from the market following infringement litigation, can't be all wrong about the advantages of an internal connection. How does the ITI Implant design stand up to these factors? 1. Not self-tapping—compromises initial stability in soft bone. 2. Flat-bottom threads, but only half the number of threads compared to the V-shaped threads of a Branemark implant or clone and with a shallow inside-outside thread dimension that provides very little surface area to dissipate load. 3. SLA surface provides good roughness without soft-tissue complications, if exposed. 4. No ability to compress bone during insertion because of the straight design. One can't readily get the implant started into an undersized hole because of its straight design. 5. The syn-Octa Implant has added an internal octagon for transfers, but is not making preparable abutments to engage the octagon. Paragon is developing an implant called the SwissPlus that duplicates the syn-Octa platform, but with self-tapping threads and a slightly tapered end to start it into a smaller hole. Each implant will be packaged suspended on a fixture mount that is also a transfer and is designed with a taper and full contour to serve as the preparable abutment. AFTER ALL, IF YOU ARE GOING
TO IMMEDIATELY LOAD AN IMPLANT, YOU WILL NEED AN ABUTMENT RIGHT AWAY
THAT CAN RECEIVE A CEMENTED RESTORATION.
Q: I have placed five Sargon Immediate Load Implants, and have been satisfied with the results. I look forward to treating more patients who are suitable candidates, bonewise. Have others had similar success stories? A: The periodontist that told me he had about 25 out of 50 failures with Sargon also told me that after 3-5 years of follow-up, he has developed a new procedure that he calls pod-ectomy. He cuts off one of the pods or spread feet of the Sargon in order to treat the trifurcation involvement that has developed with bone loss. Do you really want to do more than these original five until you have had a chance to observe at least 3 years follow-up on the ones you have placed? Any solid, screw-type, self-tapping implant with a rough or HA coating will work just as well or better for immediate load without the risk of creating a trifurcation involvement. And let’s not forget the instability of the standard external hex connection of the Sargon Implant. Do you really think that is the most stable platform to use for single tooth replacements? Q: I placed and engaged the Sargon implant as high as possible, immediately loaded (completely out of occlusion), and followed the apparent stimulation of new bone by the implant. This is, of course, anecdotal, but apparent on X-ray. Some four months later, the final restoration has been placed following weekly evaluations that indicated no required expansion after the first visit and no mobility (excellent ping) since placement. Can any other implant design match this kind of success? A:
If you think that this success was do to good initial stability or,
perhaps, initial spreading of the pods (although you don't indicate
this), then an implant like the Advent or the MkIV, which are tapered
but placed into a straight hole for bone expansion, would accomplish
the same thing. Secondary spreading of the pods is a fallback position
if the initial loading causes loss of integration. A study in Belgium
tested four different implant materials in immediate loading: HA, TPS,
Paragon's SBM and a resorbable HA. They all worked, and the SBM-blasted
surface achieved 60% bone contact. You won't get that with a smooth
machined surface like the Sargon or Brånemark implant. Logic dictates
that a grit-blasted or coated, tapered, self-tapping implant placed
into a straight hole for bone expansion should give you the best chance
for success without the long-term risks of fractures or trifurcation
evolvement from a molly bolt design that must spread to achieve its
initial stability. Because of this molly bold design, the Sargon implant
can't be coated.
Q: I have started using the Paragon System, but I am still using the Endopore System for situations where there is poor bone quality. What approach does Paragon use for soft bone? A:
I am pleased that you have started to use the Paragon System. The tapered
Screw-Vent and AdVent implants were specifically designed to gain increased
initial stability in soft bone. This is achieved by inserting these
tapered implants into an undersized socket prepared with a straight
drill. For consistent success in soft bone, initial implant stability
is critical. Self-tapping threads and bone expansion are design features
that will better achieve this than inserting a tapered, non-threaded
implant into a tapered hole like with Innova's Endopore implant. It
just makes sense.
Q: Have any of you used, or are at least familiar with, Endopore implants by Innova? If so, I would appreciate your assessments of this system. A: Endopore is a good example of what not to have in an implant system. Let's list the important features to look for in any implant system and see how Endopore stacks up: DESIGN FEATURE OBJECTIVE #1: Achieve initial stability that is critical for osseointegration. The following are the design options in decreasing order of desirability to meet this objective: A. Self-tapping tapered screw implant inserted into straight hole to create bone expansion: AdVent from Paragon offers this for all qualities of bone; Mk IV from Nobel Biocare has it for type 3–4 bone only, because the hex is too weak for dense bone. I patented this method of insertion in 1993 and have put Nobel Biocare on notice of infringement.
B. Self-tapping straight screw: A number are available on the market. Screw-Vent has apical vents to harbor bone chips, rather than deep grooves that reduce thread surface, as found in self-tapping implants from 3i, Lifecore, Spine and Nobel Biocare.
C. Non-self-tapping straight screw: Any fully coated screw implant would not be self-tapping in dense bone, as coatings round cutting threads. Paragon’s patented Selective Surface keeps the apical end sharp by blasting or coating only the midsection of the implant.
D. Straight, Press fit cylinder with parallel walls: A number are available on the market, but only Paragon's Bio-Vent has a patented apical vertical and cross-vent that communicates with vertical grooves so that the hydraulic resistance to full seating from trapped blood can be dissipated.
E. Tapered Press fit with ledges, fins or beads: Innova fits here, as does Bicon. Paragon's patented Micro-Vent2 is tapered and has ledges but it also has apical self-tapping threads. DESIGN FEATURE OBJECTIVE #2: Implant-to-bone surface. The most desirable is one with both macro irregularities for bone ingrowth and micro irregularities for bone attachment. In addition, a bioactive surface (HA) increases bone attachment strength. The optimum surface is one that offers these features, but will not present a soft tissue complication if the rough surfaces become exposed to soft tissue. The following are the design options in decreasing order of desirability to meet this objective: A. A Self-tapping screw starts out with bone between the macro-irregularities of the threads. Beaded surfaces, such as the Endopore, or deep, non-self-tapping threads, such as on the Maestro, require bone to grow into macro-irregularities. If the screw is blasted or TPS coated, this will increase the micro-irregularities and increase both percentage and strength of bone attachment. HA coating also increases micro-irregularities while further enhancing attachment strength and early healing. If the implant has a blasted transition zone between the crest of the ridge and the TPS- or HA-coated surface, the bone recession will stop on the blasted zone and not expose the HA or TPS. Paragon’s patented Dual Transition Selective Surface on the Micro-Vent2 and ADVENT implants meet all of these objectives.
B. HA-coated surface: The trade-off of using this surface without the transition zone or without the self-tapping efficiency of Paragon's Selective Surface is worth its use in order to get increased success in soft bone. It is worth the risk of soft-tissue complications, if exposed, but the dense HA now being used by most manufacturers is actually relatively smooth and should not be a problem, if exposed. The VA study used 1700 HA-coated Paragon implants that only had a 0.5 mm smooth collar, and reported no significantly higher soft tissue complications than acid etched implants at the 3–5 year follow-up.
C. Surface roughened from blasting: This next-best choice can be accomplished with a soluble material (SBM from Paragon, RBM from Lifecore, Maestro), or by blasting with Al2O3 followed by acid etching to remove the contamination (SLA from Straumann). These surfaces are not so rough that they will cause soft-tissue complications if exposed, but do add to the attachment strength of the bone.
D. TPS coated surface: This treatment increases surface area, but its rough, interconnecting pores can lead to soft-tissue complications, if exposed. This is why ITI changed from TPS to SLA.
E. Machined surface with 10u grooves: Although this smooth surface is not really desirable, at least bone loss does not expose a very rough surface that can cause soft tissue complications. Core-Vent's implants acid-etched with HF/NO3 used in the VA study produced pits about 10u in size and demonstrated significantly higher failure rates in Type 1 bone (7% difference), and even a greater difference in Type 4 bone (20%). The difference in success was less dramatic in the hands of experienced and skilled surgeons, but was still significant. After 1997, Paragon replaced this surface with the blasted SBM surface, which is created by blasting with soluble tricalcium phosphate.
F. Acid etched with 1-2u pits: This surface created by acid etching with HCl/H2SO4 (Osseotite) is even smoother than a machined surface. It should prove to be even less successful long-term in porous bone than the standard machined surface. Sullivan (JPD 1997;78:379–386) reported 36% failure in type 4 bone with this implant (4 out of 11 implants). Lazarra's early loading studies excluded implants placed in Type 4 bone, although the article failed to mention it (J Esthetic Dent 1998;10(6):280–289). This was later acknowledged by 3i.
G. Beads that create large interconnecting pores below a smooth neck: When bone recedes down the smooth neck (Endopore), as it will inevitably do, the beads are exposed to the gingival sulcus and can lead to soft-tissue complications. With rough surfaces like HA or TPS, the surface can be exposed and smoothed to treat such complications. Beads offer no such opportunity. In the late 1980s, the University of Toronto group that developed the Endopore surface reported about 50% failures in dogs due to infections from the exposed beads. When this implant first came to market, it had a 2 mm long neck to compensate for the risk of exposure, but this only encouraged bone recession and exposed the beads anyway. Innova eventually shortened the neck of the Endopore implant to 1 mm and accepts the fact that the top of the beaded surface may become exposed. There are no comparative clinical studies showing that Endopore works any better in a short length than short HA- or TPS-coated implants. Duke Heller of the Midwest Implant Institute did the clinical studies to meet anticipated FDA requirements, and informed me that he had good success with the very short Endopore, but eventually had failures or complications with about 20%–25% of the ones that were 12 mm long. I cannot explain why this would be the case, other than to speculate that the shorter ones were in denser bone not as susceptible to bone recession that would expose the beads. DESIGN FEATURE OBJECTIVE #3: Implant-abutment connection designed to prevent loose screws by eliminating tipping and rotational wobble. The following are the design options in decreasing order of desirability to meet this objective:
1. This should be no surprise! The only connection in the industry that eliminates both tipping and rotational movements, while still providing indexing for transfers, is Paragon's patented internal and tapered external hex implants with friction-fit abutments. Of the two, the internal hex with a lead-in bevel provides twice the interdigitation surface and better tactile sense than the standard external hex. This eliminates the need for X-rays to verify seating. The internal hex, with its lead-in bevel, does not have the limitations of the external hex with a shoulder that, if placed subcrestal, can contribute to soft tissue entrapment when seating the abutment.
2. Internal hex connections like Friatec (now Friadent), without friction-fit connections and without a lead-in bevel for added resistance to tipping forces and prevention of soft tissue entrapment on abutment seating. Friatec is being sued by Paragon for patent infringement.
3. Conical connections: This design (Astra and ITI) eliminate tipping movements. However, both of these companies recognize the need to have an internal hex or octagon for transfer capabilities and have recently added this feature. ITI is being sued by Paragon for patent infringement and Astra has been put on notice of infringement.
4. External hexes: These connections have a well-documented history of screw loosening. The lack of tactile sense has resulted in documented incidences of incomplete seating of transfers and abutments that lead to inaccuracies and costly remakes. Longer hexes improve tactile sense but increase interference with esthetics when using angled abutments. Innova has both the 0.7mm standard and 1mm long external hex connection.
5. Spline: This connection is no better than a 1 mm external hex, but is so weak in the 3.3mmD implant that Calcitek can't use this connection in their small diameter screw implant. This necessitates use of different Calcitek implant connections (3.3mmD external hex and 4.0mmD spline) screw implants in the same jaw, adding to prosthetic confusion. Because the tapered abutments for the Spline implant must be made in two pieces, you can not do much preparation on the bottom 2mm of the abutment. This necessitates countersinking the implant so that the splines are level with the bone. This, in turn, necessitates cutting away bone at the time of abutment attachment, as the wider contour abutments do not match the profile of the cover screw. Spline, in effect, turns a 2-stage procedure into a 3-stage procedure.
6. Morse Taper: This design (Bicon) eliminates tipping and there can be no loose screw problem, because there are no screws. It is, nevertheless, in my opinion, the worse connection, because it can and does loosen in some instances. Furthermore, it does not allow for transfers to indirectly prepare the abutments. Another shortcoming of the Bicon connection is that it creates an undercut between the abutment and the implant that requires countersinking the implant 3–5mm below the crest of the ridge. This is done in order to get the height of contour of the abutment lower to fabricate a restoration with a subgingival margin. In addition, this requires countersinking the crest at the time of implant placement to fully seat the abutment. It turns a two-stage procedure into a 3-stage procedure. I have covered the three most important factors in implant design: the body, the surface and the connection. Innova brings nothing to the party other than an unsubstantiated theory/marketing story that the relatively smooth beads, with large pores in between, will somehow enable it to be used in a shorter length than competing implants. Keller from Mayo published on Brånemark implants used in the resorbed edentulous symphysis with only 4–5mm engaging bone, and had very high long-term success. I hope this method of categorizing the implant features will provide you with a method of self-evaluating the systems you are using. Don't get hung up on one feature (e.g. beads on the implant surface) to the distraction of all the other important elements of an implant system, including the ones mentioned above: strength of material, abutment design, packaging, drill efficiency, customer support and price. JUST THINK ABOUT IT!
Q:
I looked at the links that
you provided on your website pertaining to 3i's false extrapolation
of published research. Am I correct in assuming that your message implies
that Paragon is the ONLY implant that is any good and that it is the
ONLY implant that should be used in dentistry? For your information,
Dennis Tarnow has some pretty good research with the Osseotite implant.
Is he wrong, too?
Q: The 3i representative in Singapore has been coming round quite frequently to promote the Osseotite implants. As what was written in your "Controversies" book, he was trying to impress us with the "ZR" abutment features and early loading and low dimensional variation. Please elaborate on the following:
Binon study in 1995 reported dimensional variation of only 1 micron. You said, "this is beyond the capabilities of CNC machines to maintain, other than for consecutively produced implants." Please explain what is "CNC" and what do you mean by "consecutively produced implants." A: CNC stands for computer numerical control. It’s just the machines that implants are made on. 3i's dishonesty was proven in a subsequent article by Binon where he acquired implants in the open market and found 13u variation—no better or worse than competitors. I think this article is also referenced in my controversies book. You’ll notice that 3i says "zero degrees rotation," but puts an asterisk to qualify this to be 1 degree. It does nothing to eliminate tipping, which stretches the screw and is the main cause of loosening. Paragon’s friction-fit abutments now come with a worldwide guarantee of no loose screws for five years.
Q: The "micro-stops" in the 3i abutments. Are these just the metal flashings that are deliberately manufactured or are they a byproduct of the manufacturing process? Kindly enlighten me so that I can rebut them when they come round again. A: What they do is broach (force) a hex to be formed of a smaller size and then go in with the right size broach that leaves some metal fragments up inside the abutment. These fragments hit the top of the implant’s hex when the screw is tightened and gives the temporary appearance of tightness. Since it does not stop tipping, these metal fragments eventually flatten out and the parts can rotate and tip.
Q: While Paragon is an excellent internal hex system, many of the participants in this group seem to use the external hex. I understand all that Dr. Niznick is saying about 3i surface and, at present, can't find fault. But if you like the external hex and like the advantages of the Paragon surface, why not look at Lifecore's RBM implant? Paragon and Lifecore, if I am not misguided, are both surfaced at the same location with the same technique. A: You are right that they are both similar surfaces. While Paragon started having its surfaces blasted by the same company as Lifecore and BioHorizons still use, we have switched vendors for better quality control. Dr. Gordon Christenssen comments on the economic advantages of Paragon implants and Binon studies show it to be superior in hex fit. Lifecore started out being a low priced implant, but now has a list price of $220 for its RBM surface implant (5mmD). They will sell at a different price to everyone (I've seen invoices as low as $100), depending on your negotiating skills. Paragon's external hex Taper-Lock implant that Binon also studied and referred to as the ultimate connection because of its tapered design and friction-fit connection, has a published price of $143. Since July 1, 1999, the Taper-Lock can be ordered over the Internet for as low as $132 for individual implant orders and $121 for orders of 20 or more. It will be economical for everyone. This price includes Fixture Mount/Transfer packaging, which saves the cost of a transfer, and is provided in 3 diameters, all with the same platform for prosthetic simplicity. It has Paragon's patented Selective Surface for efficient, self-tapping insertion, and is made of work-hardened, Grade 4 commercially pure titanium (cpTi) with a tensile strength of 112 ksi vs. Lifecore's Grade 3 cpTi at 65 ksi. Paragon manufactures all its own implants, thereby assuring quality control. In contrast, Lifecore utilizes machine shops. Another text to look at is the FDA report on fractured implants that was reported on the IHS Medical Devices Database 6/97. This lists the number of fractured implants the manufacturers are required to report: Noblepharma 483, Dentsply 374 and Lifecore-0 (zero). Paragon has never had a report of a fractured Taper-Lock external hex implant and the fractures you refer to were mostly small-diameter Screw-Vents when we were making them out of CP Ti instead of titanium alloy. I am just responding to your commercial comments about the Lifecore system. The best way to solve problems is to avoid them and the selection of a system is the best place to start.
Q: I became a user of the Core-Vent Implant System back in the mid 1980s and I thank God that I didn't place more than a couple hundred of those bendable cemented abutment heads that ultimately fractured! After using Core-Vent, Screw-Vent, Sterri-Oss, Calcitek and ITI/Straumann implant systems, I can honestly say that the Straumann implant is the way to go, period! A: I was recently sent a panoramic radiograph of a 17-year follow-up of a fixed bridge on the narrow bendable heads done by a prosthodontist. While we had a higher than expected incidence of breakage, a lot had to do with how many implants were used, how long the span was, the angle of implant placement and how passive the framework fit. The bendable head abutment was used with blade implants for decades. Core-vent also offered the first castable abutment heads in 1982. Both were crude methods of dealing with angulation problems that were not even being addressed by the Brånemark System. I made the bendable heads out of commercially pure titanium. This material was weaker, but more ductile than the titanium alloy used for the implant to ensure that the abutment could be more easily ground out, if fractured. By 1986, the bendable heads were replaced by cementable, titanium alloy non-bendable heads that fit flush with the top of the implant. During the same year, the internal hex connection was invented for the Screw-Vent and ultimately replaced cemented heads. So much for ancient history. As for the Straumann system, it certainly had its evolutionary problems as well. In the 1980s, they sold a basket implant with a neck that was narrower than the body, creating a defect at the crest of the ridge. Consequently, they redesigned their implant and, in 1991, came back into the American market with the Bonefit basket implant with external threads. This implant infringed the Core-Vent patent and ultimately, after a week trial, Straumann was found liable for a considerable amount and enjoined from selling the implant that all their research was based on. After 6 months, they decided to take out a license, paid me even more money and sold this implant until the license ran out last year. To avoid paying any more royalties or to solve their implant breakage problems with this thin-walled basket design, Straumann's implants have evolved into a non-self-tapping, solid screw implant with a round bottom. This implant, called the ITI System, had a conical connection without an internal indexing means (hex or octagon) until this year. As a result, they could not do transfers, nor could they make the abutment hit on the internal taper and on the periphery at the same time. Therefore the top of the implant become the margin of the restoration. This presented numerous prosthetic and esthetic limitations that most dentists are aware of. Several years ago, ITI experienced a rash of breakages with their conical abutments, which necessitated an FDA recall. Straumann finally acknowledged the need for internal indexing by incorporating an internal octagon on all the implants they are now manufacturing (still selling some odd sizes in the old design). Straumann's internal octagon violates Paragon's internal wrench engaging patent and we have filed a lawsuit in Los Angeles Federal Court. Apparently the Swiss need another lesson in violating my patents. Eight other companies have already learned this lesson including 3i, Lifecore, Steri-Oss and Calcitek. You should get a copy of my CD-ROM to better understand the prosthetic limitations of using a system where the margins of the restoration are established at the time of surgical placement or where there is no transfer capability. If this doesn’t persuade you to take a second look at Core-Vent/Paragon, then you should be happy to learn that Paragon is now making an ITI clone and selling it for the same price it sells the Taper-Lock external hex implant; $121 each. I feel compelled to do this because Straumann has chosen to violate my patent rather than negotiate a license. Since the patent also includes abutments that fit into the internal hexagon/octagon of an implant, Straumann may soon find themselves with thousands of internal octagon implants inserted, but without the ability to sell the abutments or transfers to go with these implants. Paragon will be able to meet these needs and transition their customers into a better-packaged and more reasonably priced implants. Since Paragon’s SwissPlus clone has an internal octagon, we provide it suspended on a fixture mount that simplifies insertion. It has one flat side so it can serve as a transfer, and is tapered so it can also serve as a preparable abutment (saving $105). Unlike Straumann's implant, it will come packaged with a cover screw (saving $20–$40). The fact that our ITI clone will be priced at $121 for a 20-implant order over the Internet represents about 70% savings compared to ITI's price for all the components. You will also be able to prepare the margins and take conventional impressions for further savings by not having to buy impression transfers and abutment analogs. The improved design, packaging and cost savings should get the attention of even the most devoted ITI advocate. How many do you want? Q: Thanks for that very enlightening response. I in fact did have six ITI abutments fracture and, although it was not a big deal to retrieve the broken piece from the implants involved, it was a nuisance nonetheless. Yes, those bendable necks from your original implant system were "a bummer" for me, but if it hadn't been for one of your lectures in the mid-1980s, I probably wouldn't have ever gotten involved in implants as a general dentist (placing as well as restoring them), period. I now place implants for over 65 referring general dentists and I honestly love the ITI system. Admittedly, it has a few shortcomings, which you have cited in your response, but I haven't truly found these limitations to be too restricting in clinical practice. Single-stage implants offer numerous advantages to the patient, as well as to the dentists, as I am sure you are aware. I'm certain that will be the future of implant dentistry as more and more dentists switch from two-stage to single stage implants. I am most happy to hear of your plans with the ITI clone! When will it become commercially available? Also, what type of surface will it have? TPS or SLA? Also, what is your take on the SLA surface that ITI has recently introduced with reduced healing time prior to loading? A: Thank you for confirming my comments about the breakage and for acknowledging my contribution to your implant career. Paragon's SwissPlus is now available and has an SBM surface that is created by blasting with a soluble tricalcium phosphate. This process uses a rather soft material to create a medium-rough surface without overly rounding the threads. You can check out the difference on our web site at ../ research/controversy/contro1_pt07-5.html. Both SLA and SBM have large (25u) craters and small (1-2u) pits compared to TPS with 40u interconnecting pores that can be a problem if it becomes exposed to the soft tissue. This is why Straumann changed to SLA, not because it can be loaded earlier. In 1986, the Core-Vent implant was blasted with large particles of aluminum oxide followed by acid etching to remove the blast contaminants. The initials, "SLA," stand for "Sandblasted with Large particles followed by Acid etching" (HF/NO3 in the case of Core-Vent, HC/Sulfuric in the case of Straumann). SLA is not a new process nor does it have any unique advantages. In fact, this two-step, aggressive process has the significant disadvantage of rounding any threads or self-tapping cutting edges on the implant. Straumann does not design their implant to be self-tapping, as it has no grooves or vents at the apex, or any vertical cutting grooves. It only has a few rounded threads, widely spaced. You don't have to wait for the ITI clone or to find out if the ITI implant, with the internal octagon, will be taken off the market because of the patent violations. The Advent has many advantages over the ITI implant or even the Paragon’s clone implant, such as: 1. Triple lead threads for faster insertion and more threaded surface area; 2. SBM surface preserves the sharpness of the threads compared to SLA; 3. Advent is also available with HA coating below a 2 mm SBM zone; 4. Tapered design for bone expansion or compression or anatomical limitations; 5. The ability to be used 1- or 2-stage with a prepackaged Implant Extender and low-profile cover screw that allow positioning 1 mm to 5 mm above the crest of the ridge. ITI requires purchase of a 1 mm healing cap at $20 or 2 mm to 5 mm healing caps for $40. ITI also offers two implant versions with 1.8 mm and 2.8 mm necks. The Advent’s variable height design eliminates the need for this type of duplicate inventory; 6. Friction-fit abutments with a 5-year guarantee of no loose screws under cemented restorations; 7. Tapered straight and angled abutments with preparable margins. They fit flush with the outside diameter of the implant, which allows preparation of margins that follow the contour of the soft tissue instead of having to use the top of the implant as a shoulder margin, as with the ITI implant. This improves esthetics and allows use of conventional impressions, which saves the cost of transfers and abutment analogs. Paragon's ITI clone, the SwissPlus, also offers a flush-fitting fixture mount that can be used as a straight preparable abutment. It accepts all of ITI's conical abutments and, depending on demand, Paragon may also make two-piece angled abutments and clones of Straumann's other abutments for both the SwissPlus and ITI implants. 8. Flush-fitting abutments also allow the dentist to vary the emergence profile for esthetics. The straight tapered abutments come in 4.5 mmD and 6.5 mmD (the wider one is packaged with a matching profile healing cap). 9. The Advent's internal hex allows transfers for indirect preparation of the abutments, or for custom-cast abutments. The transfers are also friction-fit for accuracy. Straumann’s new internal octagon, which is the subject of the patent infringement lawsuit, is designed to also allow transfers, but they will not be friction fit. 10. The Advent's internal hex also provides a very strong wrench-engaging surface for implant insertion. Straumann's new internal octagon can also be used for implant insertion if its fixture mount is removed. Straumann's implant is package with a fixture mount that relies on thread engagement for insertion This requires an awkward method of using two tools to detach the fixture mount: one to stabilize the mount while the other loosens the center screw. Paragon's SwissPlus clone improves this. 11. Less expensive components:. Instead of having to add an Octabutment from Straumann for $105, the top of the Advent converts to a screw-retaining abutment by adding a $40 Tapered Screw. 12. For tissue-supported overdentures, a Ball Screw or Zest anchor (ZAAG attachment) screw is attached to the implant, which offers further prosthetic versatility. Advent has the same amount of threaded surface as a Branemark or Screw-Vent, but goes in 3 times faster, because it has three independent threads starting 120 degrees apart and intertwining with each other. The space between the individual threads is 1.8 mm but together, adjacent threads are only 0.6 mm apart, like a standard Brånemark thread. Paragon's Screw-Vent has Selective Surface with the apical 3 mm uncoated or unblasted to keep the cutting edge sharp for self-tapping. The Advent, on the other hand, has an SBM roughened surface to the apex where it also has an apical vent and vertical cutting grooves for self-tapping. As this tapered design is inserted into a straight hole, the lower half of the implant partially cuts threads in the bone while mainly expanding or compressing the bone with the upper half of the implant. The surgeon varies the amount of bone expansion/compression desired by the size of the hole that is cut before inserting the implant. For example, to insert a 3.7 mmD implant in soft bone, the final drill is 2.8 mm D. To insert the same implant in dense bone, the final drill is 3.2 mmD. As when Core-Vent introduced the first Branemark clone, called the Swede-Vent implant, in 1987, the purpose of the ITI clone (i.e. SwissPlus) is not to endorse this design, but due to the fact that we can retain the original design of the implant while making prosthetic and packaging improvements and offering it for a lower cost. As demonstrated above, if you are looking for a design that is significantly better than the ITI implant, while still keeping true to the one-stage protocol with the fluted neck emergence profile, the Advent is the obvious choice.
However, if you still want the SwissPlus, you can order through our web site at www.paragon-implant.com, or by contacting your Paragon Territory Account Manager at (800) 877-9991.
Dr. Niznick’s Response: What buried microgap? The top of the implant will still be 1.8 mm above the crest of the ridge if you dropped 1 mm of the machined neck below the crest. I don't know any literature related to biological width and implants. This is just a theory extrapolated from teeth to implants. If it were true, then there should be no bone loss around an ITI implant because the microgap is well above the bone. In a study by Hammerle, however, ITI implants lost 1 mm of bone and exposed the TPS. Hammerle showed that when he pushed the TPS 1 mm subcrestal, bone ran down the smooth machined surface and still exposed the TPS. This study resulted in two things with the ITI system. One was the introduction of implants with just 1.8 mm of a machined neck for subgingival margin case. The other is that Straumann eventually changed to an SLA surface. It was apparent that the rough TPS would eventually become exposed, anyway. A recent article compared the Astra implant, which features a surface blasted all the way to the top, side-by-side with the Branemark implant, which has a plain machined surface. The study showed no significant difference in bone loss between the two implants. What these two studies together show is that you are going to get bone loss and that what becomes exposed should not be so rough as to collect plaque. The VA study showed that bone loss was related to bone thickness surrounding the implant at time of placement.
When a subgingival margin is desired and the tissue is thin, the idea behind dropping 1 mm of the 2.8 mmL machined surface into the bone is to create a subgingival margin when the tissue is thin. This eliminates the need to maintain an inventory of two implant types that differ only in the lengths of their machined necks, such as Straumann requires (2.8mm neck and 1.8mm neck). I decided not to make the short neck implant because the chance of loosing 1 mm of crestal bone is of no clinical significance. Doubling one’s inventory of implants just to avoid 1mm of machined neck subcrestal, on the other hand, is a real practical concern. ITI User: 1 mm of machined collar would be exposed. No big deal. But, if you use the implant with the shorter machined collar, there would be no machined surface exposed. Dr. Niznick’s Response: As you said, no big deal...and its better to have 1 mm of a machined neck exposed than 1 mm of TPS that you were willing to accept for years. ITI User: According to Cochran, approximately 2 mm is necessary below the microgap. Who knows? Dr. Niznick’s Response: I know! If you read Cochran's study, you will see that he used test specimens with 50 micron gaps when even the Branemark implant only has about a 5 mm gap (and ours is about 3 microns). So, what Cochran did to ingratiate himself to Straumann is create a phony study to support the ITI design theory that you needed to keep the implant/junction at least 2 mm away from the crest or you would get bone loss. ITI User: I'm also not crazy about your cementable abutment. I prefer to have the finish line on the implant shoulder. Dr. Niznick’s Response: You want so badly to justify that the ITI system is better than others that you are fooling yourself. Do you create a shoulder around every tooth preparation? I doubt it. Even for porcelain jacket crowns where you would require a shoulder preparation, you do not prepare it at the same height around the entire tooth. You follow the tissue contours. So, why in the world would you want to be forced to restore to a shoulder around the implant at the same height above the bone, and ignore differences in tissue contours? I can’t imagine any periodontist that would recommend a 3-4mm subgingival cemented margin, which often occurs on the lingual, just so you can get the labial margin 1 mm below the tissue. ITI User: The SwissPlus fixture mount/abutment requires a lot of prepping to achieve a finish line. The ITI abutment needs no prepping. Dr. Niznick’s Response: Nothing says you have to prepare a shoulder after you shorten the SwissPlus fixture mount to make them usable as an abutment. You can create a chamfer margin on the lingual and interproximal surfaces and only create a shoulder on the labial IF you need room for porcelain. Subgingival margins with porcelain shoulders are not really needed for lower posterior restorations. In the esthetic zone, a two-piece implant, such as the Tapered Screw-Vent, gives you the freedom to create the ideal emergence profile and lower the margin to the crest of the ridge, if necessary. Straumman's website makes the following claim: "The innovative octagon opens the door for the synOcta® system to provide additional prosthetic flexibility. Abutment selection can take place, as is presently the case, in the patient's mouth or on the master model. This enables extensive restorations to be planned in teamwork between the dentist and technician...Experience has shown that this method of selection -- especially for more complicated restorations -- is more cost effective and efficient, with the added advantage of reducing the actual treatment time for the patient." FACT: The advantages of increased "prosthetic flexibility" with an implant system featuring an internal, anti-rotational connection have been available from Core-Vent Corporation since the internal hex was first introduced in 1986. If one wanted to make a custom-cast abutment for the old ITI, one had to attach the OctabutmentÒ , make a transfer impression, wax up and cast to a gold coping that extends over the shoulder of the ITI implant, attach the gold coping to the Octabutment in the mouth, and then make a conventional impression to fabricate a fixed prosthesis. The average cost would be in excess of $400 per abutment unit, plus a lot of wasted chair time. Straumann now offers a castable plastic pattern in lieu of the gold coping. However, it is designed to snap over the undercut of the implant, and then requires dressing down the overlap once it has been cast. This adds to the inaccuracy of the margin. Such inaccuracy is eliminated by SwissPlus, which allows dentists to attach a full-contour abutment directly to the implant in the mouth, prepare the margins intraorally, make a conventional impression and pour up a stone die. Alternatively, a transfer can be made since there is an internal octagon in the SwissPlus and synOctaÒ implants. The titanium abutment can then be prepared on the working cast. Paragon offers a combination abutment/transfer for use with the synOcta implant. This component is not required with the SwissPlus implant, since the fixture mount also serves as a transfer and preparable abutment. This fixture mount is indexed for accurate orientation of our SwissPlus 20-degree Angled Abutment. If the flat is placed to the labial, the Angled Abutment will be directed to the lingual. ITI User: I understand that the cost savings are significant for SwissPlus in comparison to ITI. However, I'll see how Paragon's new stuff holds up over the next couple of years before I make any changes in what I'm doing. Dr. Niznick’s Response: You don't seem to have to wait to see how Straumann's new stuff holds up for a few years before you use it. How do you know the internal octagon, which reduces the surface area of their conical connection, will "hold up" and not cause more implant breakage or loose abutments? Our implant uses work-hardened Grade 4 Ti. Its surface treatment is very similar to SLA, but does not round the threads. The self-tapping feature and sharp threads will ensure a tighter initial fit with the SwissPlus, which should enhance success in poor quality bone. Unlike the synOcta or regular ITI implant, the apical end of the SwissPlus is tapered. This facilitates initiation into an undersized socket prepared in soft bone to provide better initial stability. Our implant comes with a healing collar and fixture mount/transfer/abutment that would have to be bought separately from Straumann.. Our transfers and abutments, as demonstrated in our SwissPlus website, fit our implants with a smoother margin than any custom cast abutment you could fit onto the shoulder of an ITI. SwissPlus’ product versatility and compatibility with the ITI implant is demonstrated on the attached slide. Surgeons will appreciate the use of a fixture mount that engages the internal octagon, because it simplifies insertion and can be easily removed without the need for counter-torque, as with the ITI system. Lifecore's ITI clone engaged the internal 8-degree taper, which results in it locking on the implant after insertion into dense bone. The only "hold up" that is going on is the one Straumann is doing to our professional colleagues with their outdated, overpriced products ... and they couldn't do it without the unquestioning acceptance of their "opinion leaders," whose loyalty they buy with a few paid lectures and a trip to Switzerland. Remember all the Branemark loyalists who blindly used smooth machined titanium implants in the maxilla with poor results, or had screw loosening from the unstable external hex implants, or had breakage from the Grade 1 CP Ti. Their patients paid a significant price for their unwillingness to think for themselves. When you see the advantages of the SwissPlus sSystem and still insist on using the ITI system, you are treating implant dentistry as a team sport, not a professional, scientific endeavor. ITI User: I read through most of the link. I have to say it is very impressive that you are still as excited about this stuff as ever. From what I could tell, your system is good. Dr. Niznick’s Response: I am very excited about being able to offer dental professionals better products at better prices. You should be equally as excited to have the opportunity to try these innovations and enjoy the cost savings and clinical benefits.
Q: After viewing www.straumann-clone.com, I must admit that Paragon’s SwissPlus System looks absolutely irresistible. However, why no small diameter implant? I find that I often need a 3.3mm diameter implant, especially in the maxillary lateral incisor area. A: When placing an implant in the upper lateral area of the jaw, where mesial-distal space is limited, you most likely need an implant with a small diameter platform. That is why I think that Straumann's 3.3mmD implant with a 4.8mmD ITI platform makes no sense. Straumann does make an implant with a small diameter platform and a tall external hex. However, due to the stacking height of its abutment components, especially if an angled abutment is required, this design has its esthetic limitations. Paragon’s narrow Screw-Vent implant with a 3.3mmD body and a 3.5mmD platform is a more practical design for accommodating narrow ridges and limited mesial-distal space. In addition to its smaller diameter platform, the narrow Screw-Vent implant features Paragon’s patented internal hex. When used in conjunction with Paragon’s friction-fit abutments, a much stronger and lower profile abutment connection can be achieved. One can then select either straight or angled abutments and prepare the margin as far sub-gingival as necessary for esthetics. Available in January 2000, the new tapered Screw-Vent implant provides the same standard 3.5mmD platform as the narrow 3.3mmD Screw-Vent. Its reengineered tapered body, with a slightly wider 3.7mmD neck and a body that tapers down to 2.5mm at its apical end, eliminates the need for a 3.3mmD implant. During placement in soft bone, the tapered Screw-Vent will gradually expand the ridge of an osteotomy prepared with a straight 2.8mmD drill, thus providing increased initial stability. This special feature also offers the benefits of greater implant body strength and greater surface area than the current 3.3mmD narrow Screw-Vent implant without increasing the diameter of the implant’s platform. Its innovative design makes it an ideal choice for replacing upper and lower lateral incisors (especially lower central incisors). The ITI concept of using the top of the implant as the shoulder of the restoration is also poorly conceived. For a ceramo-metal crown, one would never prepare a shoulder on an anterior tooth all around the circumference of a tooth at the same height because it complicates impressions. Straumann's design requires transfer jigs, centering sleeves and analogs to capture the impression of this shoulder. Even if one were preparing a tooth for a porcelain jacket, it is not advisable to create the shoulder at the same height above the crest of the ridge all the way around the tooth. Instead, the preparation would follow the contour of the soft tissue so that the margin would be the same depth sub-gingival. Full contour emergence profile abutments that cover the shoulder of the SwissPlus (or for use with ITI's synOcta implant) allow such latitude in establishing the margins with a minimum of sub-gingival depth. Straumann's own realization of the limitations of its design has lead it to venture into violating my patent by incorporating an internal octagon for transfer capabilities. They fail to take full advantage of this internal anti-rotational feature by still advocating their solid abutments, leaving the shoulder exposed. Alternately, Straumann recommends attaching the Octabutment® , directly or indirectly following making a transfer impression, and using a gold coping that covers the shoulder to fabricate a custom cast abutment. This does allow positioning of the margins at varying heights and fabrication of angled abutments. It may require a second impression and is unnecessarily complicated and expensive. Paragon's SwissPlus provides a 2-piece fixture-mount that covers the shoulder of the implant and can be used as the transfer for indirect preparation, or shortened chairside and then prepared in the mouth. Paragon will not be making clones of Straumann's ITI's Esthetic Plus series of implants with the blasting or coating running 1 mm higher than the standard implant. This design is recommended by Straumann for placement when only 2mm of the neck is desired to be projecting above the crest of bone for esthetic sub-gingival margins. It is another example of Straumann's lack of appreciation of the cost to dentists of holding large implant inventories. One can easily drop 1mm of the 2.8mm machined neck of the SwissPlus or ITI implant sub-crestal and achieve the same esthetic results. It is not worth stockpiling a different implant inventory just to keep the machined neck from being 1mm sub-crestal. A recent study comparing the machined surface Brånemark Implant to the Astra Implant, blasted to the top, showed no difference in bone loss after a year. The price of the new implant is $180 including a 2mm cover screw and the fixture-mount/transfer/abutment, but the price drops to $165 with orders of 25 implants (buy 23 @ $180 and get 2 free). You will also find the insertion of the self-tapping SwissPlus and the ease of detaching the two-piece fixture-mount a real (OCTA) plus.
Q: Steri-Oss has introduced three internal half-circles for anti-rotation in the Replace Select™ implant. How does the Replace Select implant with its new connection compare with Paragon's implants? A: The Replace Select™ implant violates Paragon's internal connection patent. We are proceeding with arbitration, as required by a 1991 agreement between Core-Vent and Steri-Oss, wherein Steri-Oss acknowledged the validity of Core-Vent's patent and agreed not to make infringing products. Contrary to claims made by some Nobel/Steri-Oss sales people, Core-Vent/Paragon has never given Steri-Oss a license to make the internal anti-rotational connection of the Replace Select Implant. Nobel/Steri-Oss' ads now proclaim that the Replace Select implant provides "What every dentist wants ... an internal connection." With Nobel's acknowledgment that, prior to the introduction of the Steri-Oss Replace Select Implant, they have been successful in persuading there customers to buy what they don't want -- external hex implants. It should prove most interesting, if Paragon is successful in enjoining the sale of Nobel's internal connection implants, what they tell their customers in order to persuade them to again buy what they admittedly don't want -- external hex implants! ADVANTAGES OF PARAGON'S TAPERED SCREW-VENT & ADVENT IMPLANTS 1. Paragon's abutments provide a friciton-fit connection with the industry's only Guarantee against screw loosening (pays lab bill and $100 per abutment chair-time). Replace Select's connection allows rotational and tipping micro-movements that cause screw loosening. 2. Paragon's internal hex design features an inward bevel in the coronal aspect of the implant, which further enhances abutment stability and allows for a lower profile cover screw than the flat shoulder and butt-joint connection of the Steri-Oss design. 3. Paragon's implants are self-tapping - Replace Select lacks apical cutting grooves and apical threads. 4. Paragon's implants provide the standard "V" shaped Branemark type threads that have been shown in a comparison animal study to provide greater bone contact surface than Steri-Oss's upside down Christmas tree threads designed to resist implant removal, not implant load. 5. Paragon's implants (Tapered Screw-Vent, Advent and Taper-Lock External Hex) provide the industry's only triple-lead threads providing 3 times faster insertion than standard threads with a 0.6 mm pitch. The steeper angle of these threads also reduce insertion torque by 12% on the straight Taper-Lock implants compared to the single thread Taper-Lock. 6. Paragon's Tapered Advent and Screw-Vent Implants are designed to be inserted into sockets prepared with straight drills. This patented surgical protocol, when used in soft bone with an undersized drill, results in compression for greater initial stability. It also facilitates bone expansion in narrow ridges, replacing the need for osteotomes. By contrast, the tapered Replace implants are inserted into sockets prepared with tapered drills. 7. Paragon's Tapered Screw-Vent implants require only 3 final sizing, step-drills to insert any of the 3 diameters and 4 lengths (3.7mmD, 4.7mmD and 6.0mmD) and the same drills work for the Advent 3.7mmD and 4.7mmD implants. Steri-Oss Replace® external hex and Replace Select® internal cloverleaf Implants require a different tapered drill for each length and diameter of implant, as well as a different bone tap for each diameter. This means that 16 instruments are needed to prepare the bone for the 12 Replace Select implants, 9 more than for the 12 (3 diameters X 4 lengths) Tapered Screw-Vent implants from Paragon. 8. Paragon's Tapered Screw-Vent implant is provided on a color coded fixture mount designed for use as a transfer and as a preparable or screw-retained temporary abutment. The fixture mount of Steri-Oss' Replace Select implant is not designed for use as a transfer or a preparable temporary abutment. Paragon's ITI® clone, the SwissPlus™ implant, has a fixture mount that is not only the transfer, but also is designed for use as a preparable abutment for cemented restorations. Another advantage of Paragon's fixture mount is that the center shaft has a hex at its opening, which accepts a hex tool connected to either a ratchet or screwdriver handle. This provides added length when placing the implant adjacent to natural teeth. In contrast, both the internal and external connection Steri-Oss Replace implants require their fixture mounts to be removed and longer fixture mounts to be attached before the implants can be fully seated in the same situation. 9. Paragon's Advent Implant is designed for a one-stage surgical protocol and is packaged with a 2 mm implant extender that provides additional height to accommodate variations in soft tissue thickness. The 3 mm long machined neck of the implant can be placed 1 mm or 2 mm sub-crestal for a two-stage procedure. Therefore, Paragon's implants are true one-stage designs with the implant-abutment junction well above the crest of the ridge. Nobel/Steri-Oss claims that its Replace Select Implant can be used as a one-stage implant by using a protocol that requires leaving the 2 mm smooth neck of the implant above the crest of the ridge. This places the TPS or HA coated surfaces at the crest of the ridge where they will become readily exposed to the soft tissue when bone loss occurs. Since 2 mm is usually not enough to protrude through the soft tissue, Replace Select require buying and attaching a healing collar to use the implant one-stage. 10. Paragon's AdVent™ and Tapered Screw-Vent Implants are available with a SBM medium rough, blasted surface that has been shown in animal studies to provide increased bone contact compared to TPS, and even equally HA in one study. These implants are also available with HA Dual Transition surface that protects the HA from becoming exposed to the oral environment by a 2 mm zone of SBM. Steri-Oss Replace implants are provided with an acid etched surface that is smoother than a machined surface, with TPS surface which is very rough with interconnecting pores that will be a plaque collector if exposed above the bone and with a HA coated surface. As of January 2000, the Steri-Oss Replace Select ($268) is priced higher than Paragon's AdVent ($245), Tapered Screw-Vent ($235-$240) and SwissPlus ($180) implants. In addition, the top of the one- or two-stage Advent is designed for use as an abutment for screw-retained restorations, which provides additional savings. Paragon's prosthetic components also provide significant cost savings compared to Nobel/Steri-Oss implant products, as shown in the comparison chart below:
*Prices as of January, 2000 **TorqTite is a registered trademark of Nobel Biocare AB
Q: I seem to have more than the expected number of acid-etched Replace® implants rotating out at the "second-stage" counter-torque test (i.e. hand pressure). However, I also experienced several larger diameter Replace implants which passed the hand torque test, but which slightly rotated when torqued to 35 Ncm. In these latter cases, I advised the restorative dentists to temporize and retest after 3 to 6 months, and they seem to have successfully reintegrated. I was concerned with these experiences and I sent my statistical results on about 200 Replace implants to Mr. Don Kennard at Nobel Biocare in California. I was unaware of anyone else having a similar experience with the acid-etched Replace. This may be due to the fact that the surface is too smooth. All the Replace implants are titanium alloy, which is harder than commercially pure titanium . Consequently, the harder alloyed metal will not have as much roughness after machining in comparison to the softer commercially pure metal! As a result, I recently returned all of my acid-etched Replace implants and have substituted them with TPS and HA Replace implants. Regarding the Replace Select (internal tripod connection), so far all the restorative dentists have been very pleased. The response has been similar to the excellent tactile sense with the internal hex of the Paragon system. I guess the competition is agreeing with Gerry Niznick that an internal connection is better than an external connection. Can anyone comment on how the Select connection compares to the "friction fit" Paragon internal hex connection? A: Thank you for the invitation to compare the Steri-Oss Replace Select vs. Paragon's internal hex implants, which I first introduced in 1986. In recent journals, Nobel Biocare has run two-page ads with the Branemark external hex implant on the left and the Replace Select implant on the right. The Branemark implant has now incorporated what they call "Stargrip" for easier insertion. It is nothing more than an internal hex with flats instead of points. In 1982, the Core-Vent® internal hex implant first simplified delivery and placement of an implant into a surgical site by allowing a hex tool to be inserted into the implant . I never thought I would see an external hex implant with an internal hex for insertion. Why retain the external hex at all? On the right side of Nobel Biocare's two-page spread, the Replace Select ad states "what every dentist wants...an internal connection." I guess this means that Nobel Biocare built the world's largest implant business by selling dentists WHAT THEY DON'T WANT...external hex Branemark® and Steri-Oss implants. This is a testament to those dentists who are willing to be manipulated by marketing rhetoric and purchased opinion leaders. It is now happening again with the Steri-Oss Replace implant. Beyond the smooth surface, there are also significant design shortcomings to the Steri-Oss Replace tapered implant that I believe contribute to the higher failure rate that you have observed. SURFACE: Steri-Oss uses the same hydrofluoric/nitric acid etching technique that Core-Vent used prior to 1997. The results of the VA study (J Oral Maxillofac Surg 1997; 55 (12) Suppl 5) convinced me that a rougher surface was needed, especially in soft bone. As for Steri-Oss' other two surface options, TPS and HA, the TPS does not provide as much bone attachment as a medium-rough blasted surface, as documented in studies by both Paragon and Straumann. As bone recedes down the smooth neck of the Replace implant, the porous TPS becomes exposed to the soft tissue, which can cause a problem. This was most likely why Straumann changed the surface of the ITI implant from the porous, rough, TPS surface to its current, medium-rough, non-porous, SLA-blasted surface. Paragon's straight Screw-Vent® implant offers TPS (rough & porous), HA-coated (rough) and SBM™ (Soluble Blasting Medium) -blasted (medium-rough) surfaces. Our new Tapered Screw-Vent, which will eventually replace the straight Screw-Vent, only features uncoated SBM surface and HA-coated surface options. Replace Select also offers HA coating, which can also become rapidly exposed as bone recedes down the smooth neck. The Tapered Screw-Vent includes Paragon's patented HA Dual Transition™ Selective Surface™ that provides 1mm of a machined neck and 2mm of medium rough, SBM-blasted surface interposed between the smooth neck and the HA coating. This safety zone is designed to impede bone recession and exposure of the HA coating. If one follows Steri-Oss' instructions to use the Replace Select implant in a one-stage surgical procedure by leaving its 2mm long smooth neck exposed above the crest of the ridge, the HA or TPS rough surfaces will be positioned at the crest, assuring early exposure to the soft tissue. Paragon offers the AdVent implant, which is designed specifically for one-stage surgery. It has the body of the Tapered Screw-Vent with a 3mm smooth neck designed to project through the soft tissue and also serve as an abutment for screw-retained restorations. This implant is packaged with a 2mm implant extender to facilitate one-stage placement, whether the soft tissue is 2mm thick or 5mm thick! THREAD DESIGN: Steri-Oss implants provide the industry's only upside down threads, which feature less thread surface than the conventional threads of the Branemark or Screw-Vent implants. Almost every screw implant design today, including the Branemark, 3i, Calcitek and Lifecore, have followed Screw-Vent's 1986 lead of incorporating self-tapping apical features. The Steri-Oss Replace and Replace Select implants, on the other hand, lack any self-tapping vertical grooves or slots. They even lack any apical threads for bicortical stabilization. The threads of Steri-Oss Replace implants actually fade away to nothing several millimeters from the apex. Initial stability is critical for achieving osseointegration. This is enhanced by self-tapping insertion, increased thread surface and rougher surfaces. In addition, the Tapered Screw-Vent, with its unique, patented, triple lead threads for 3 times faster insertion, offers a soft bone surgical protocol of inserting the tapered implant into an undersized socket. The resulting bone expansion provides even greater initial stability. AND LETS NOT FORGET COST AND VALUE: Tapered Screw-Vents sell for considerably less than the Replace Select Implant ($235-240 vs. $268), and offer either a blasted surface or an HA-coated, Dual Transition Selective Surface that's blasted between the smooth 1mm neck and the HA coating. Tapered Screw-Vents offer added value because they are mounted on fixture mounts that can be used as transfers and as a temporary abutments. FOR ADDITIONAL INFORMATION AND A FULL COMPARISON OF COMPONENT COSTS, LINK TO: ../company/DrNiznickOnsec4.htm#sterioss Q: Are there any dentists who have been experiencing "more than the expected" number of "early failures" with TPS Replace implants? Some of you may recall previous discussions over concerns that acid-etched titanium Replace implants may lack adequate mechanical retention. In my experience, this problem with the titanium Replace implants typically manifested itself at the time of "osseointegration verification." Some Replace implants would unscrew out of the bone when removing the healing abutments, while others would turn slightly when torquing the final abutments. I theorized that this is due to the relatively smooth titanium alloy surface combined with the lack of aggressive apical threads. The result was an implant design with insufficient mechanical retention. The pattern of the TPS failures I have recently experienced is different from the titanium implants. With the TPS, there has been an acute reaction within days after initial placement. Typically, there is a loss of the facial bone and a deep pocket. The implants are not mobile, but can be easily counter-torqued out of the bone. My hypothesis to explain this phenomenon with the TPS Replace is different, however, from that of the titanium Replace. Perhaps the thicker TPS coating on this particular design results in too much compaction of the hard tissue, and thus leads to a higher risk of pressure necrosis in the bone. I am not condemning TPS on other designs, as I have had excellent success using the TPS ITI system, with up to 6 years of follow-up.
A: In addition to avoiding the overheating of bone during surgery, initial stability is the main factor in achieving osseointegration. The threads of the Replace implant are upside down, with too shallow a depth and too much flat space between the threads. As you pointed out, there are no apical threads. Replace is a tapered implant that is inserted into a tapered hole. Therefore, the threads do not start to engage the receptor site until the implant is inserted approximately half way. The implant is not self-tapping in dense bone (i.e. a bone tap is required), which reduces initial stability. In soft bone, the round apex hits the bottom of the osteotomy and any further turning will strip the threads in the bone. Without apical threads, there is no chance for bicortical stabilization, which is so critical in soft bone. HA may overcome these design limitations but, as you pointed out in a previous report, the smooth acid-etched surface has not consistently achieved osseointegration. Now you are reporting that TPS on the Replace has a problem. Perhaps it is the fact that applying TPS coating rounds off the sharp cutting edges of the threads. This further reduces initial stability and more easily allows for stripping of the threads once the implant has bottomed out. Because the Replace implants are tapered and inserted with a tapered drill, they require a different drill for each implant length. This means that, to place three lengths and four diameters (12 implants), a dentist must buy 12 drills and four bone taps. The self-tapping Tapered Screw-Vent and AdVent one-stage implants are inserted into a socket prepared with straight drills. Therefore the three diameters in four lengths (12 implants) only require three final sizing drills. The Tapered Screw-Vent offers the industry's only soft-bone/hard-bone protocol. In soft bone, the intermediate drill is used as the final drill (a tapered implant design is essential for this procedure). The final drills are step-drills, which allow the narrow apex to engage the dense bone and easily self-tap during placement. Using a bone expansion/compression procedure in soft bone increases initial stability and enhances the ability to load implants early in soft bone.
Q: I have launched a new Implant Device Module on my website that discusses the differences in implant systems. Would anyone like to offer comments and feedback on it? A: In response to your invitation for "comments and feedback" on your "new module that discusses the differences in implant systems," I would like to like to share my opinion of your analysis with you. Hopefully it will influence you to make changes based on clinical realities and published research, which seem to take a back seat to your opinions and personal preferences. Your Implant Device Module starts out with the statement: "At the present time with regard to endosseous root-form implants, there is no indication whatsoever that any given implant surface, treatment, prosthetic attachment, placement technique or brand of implant offers any perceptible advantage to the patient....At the present, all of these root-form implants are created equal in terms of their effectiveness for patient treatment." This is like saying that, just because all computers can run Windows, they all are equal in their effectiveness. I have a great laptop, which is a Dell Inspiron 7500® with a Pentium II® 366mhz processor. I just ordered the new Inspiron 5000® with a Pentium III® 500mhz processor that steps up to 650mhz when operating on AC current. Only Sony and Dell currently offer this new step-up technology, which initiates a fan to cool it when operating off of AC current. The Paragon Implant System is to implants as the Inspiron 5000 is to laptops today—cutting-edge technology. The Branemark® System and its clones are stuck somewhere between the 286 and 486 chip technology. Branemark has the best research to prove the limitations of its relatively smooth surface in poor quality bone and Grade 1 commercially pure titanium, with regard to implant weakness, hex distortion and screw loosening. If I were to tell you that there is no indication whatsoever that any given computer offers any perceptible advantage to the user, you would think that I don't know enough about what is important in evaluating computers, if I could make such a ridiculous statement. Do you get my meaning? Your introduction further states: "Someday we might have an implant or a surface or a technique that really proves superior in terms of patient treatment. When that happens, I will be the first to jump on the bandwagon." The fact is that the wagon has already left the station without you! I spend over $3,000,000 in co-funding a government study conducted by the Department of Veterans Affairs at 32 Study Centers. In fact, the U.S. government contributed triple that amount in treatment time alone! If nothing else, the study proved that HA surfaces worked significantly better than acid-etched surfaces in soft bone. These results held true regardless of whether the implants were placed by inexperienced operators, implanted in smokers, failed to achieve initial stability, or were inserted into patients without preoperative antibiotics! This was a double-blind, double peer-reviewed study that compared 2 to 3 different implant designs and/or surfaces side-by-side in the same patient under the same loading conditions. Given my investment in good research that benefited the entire dental profession, it pains me to see you totally ignore published research in favor of your own opinion. It wouldn't be so bad if you kept your opinions to yourself, but you publish them as if they were facts ("no indication whatsoever") on your website where unsuspecting dentists can be influenced. Do them and yourself a favor by doing your homework before you post your unsubstantiated and, for the most part, misguided opinions about the relative merits of implant systems. You can start with the following items available free of charge on Paragon's website:
IMPLANT HISTORY ON YOUR MODULE: You credit Branemark with discovering osseointegrated implants dating back to 1952. This is just part of the marketing myth created by Nobelpharma (now called Nobel Biocare). In 1969, Branemark tried to get a patent on a two-stage implant, but was turned down because several French two-stage implants had already been patented. In Branemark's 1977 textbook, he credits [Gottlieb and] Leventhal (1951) for being the first to report bone attachment to titanium. After that, however, Nobelpharma/Nobel Biocare claimed that he discovered this process and never referenced Leventhal again. When, in litigation, Core-Vent claimed this was false advertising, Nobelpharma/Nobel Biocare acknowledged this by changing "Branemark discovered osseointegration" to "Branemark observed osseointegration." You list the Branemark® implant as "tried and true." If the Branemark implant were so reliable, Nobel Biocare wouldn't have had to introduce four variations to this design and then buy Steri-Oss to be competitive. In the late 1980s, Nobelpharma/Nobel Biocare introduced the conical neck Branemark self-tapping implant, which was very quickly pulled off the market in Canada for excessive bone loss. This design quietly disappeared in the U.S. Nobel Biocare recently reintroduced the implant with the recommendation that the long, unthreaded neck be used for one-stage procedures. Their second attempt at a self-tapping implant was the Mk II®, which had very deep apical grooves that eliminated most of the thread surface in the apical 4 mm of the implant body. This, like its replacement, the Mk III® and Mk IV® implants, cannot be used self-tapping in dense bone because the hex strips at about 9 in/lbs. In contrast, Paragon's internal hex strips at 18 in-lbs and our Advent at 32 in-lbs. The Branemark Mk II has now been replaced with the Mk III (without apical grooves) and the Mk IV (slightly tapered for soft bone expansion). The Mk IV is an attempt to overcome the well published higher failure rates in soft bone with the Branemark implant, while keeping their machined-only surface (a cause of the higher failures) for marketing purposes. Nobel Biocare has a long history of being unwilling to change materials, connections or surfaces, even in the face of mounting published evidence that changes were needed. Is this what you mean by "tried and true?" You also fail to list the three decades of implant fractures and the stripping of the hex with the weak, Grade 1 commercially pure titanium used in the Branemark implant as a possible disadvantage. Lekholm reported in his 20-year study (JOMI 1989) that, of the the Branemark implants followed for 15 years, 16% of the maxillary implants fractured. Dr. Stephen C.Eckert of Mayo Clinic reported 8% of the Branemark implants used in the posterior mandible fractured. Mel Schwartz said that 50% of his Branemark implants fractured when used in the lower posterior mandible (USC 1996 Symposium). On the other hand, you do say that fractures of internal hex implants is a possible disadvantage. This is an unfair generalization since there are many diameter options available with internal connections. When the proper number and diameter of implants are used with a properly designed prosthesis, internal hex Screw-Vent® implants are less likely to fracture than the Grade 1 and 3 commercially pure titanium external hex implants. This is well documented with comparisons of 30-degree compression tests that are published on our website along with excerpts of a Binon article showing the stability of both our internal and external friction-fit connections: ../Brochures/Inside_Story/Page2.htm
You list Paragon's many options as both an advantage and disadvantage. One-dimensional implant lines, such as Innova's Endopore®, which offers only one surface (beaded), one shape (tapered), one platform (external hex), one design (non-threaded) and one surgical protocol (two-stage), you list as having no disadvantages. Similarly, you list Steri-Oss advantage as having "lots of choices," but do not list this as also being a disadvantage, as you do with Paragon. In fact, the Steri-Oss System® includes 6-7 different external hex platforms. It is no wonder their restorative catalog includes 149 abutment options for cemented restorations. Now that they are owned by Nobel Biocare, the combined product lines offer approximately 10 different platforms, none of which have cross compatibility. However, you do not see this as a disadvantage for either company! More recently, Nobel Biocare's introduction of the Steri-Oss Replace Select implant with an internal connection sparked patent litigation with Paragon. Nobel Biocare's ads say "What every dentist wants... an internal connection." I guess this means that they have been selling what every dentist doesn't want, an external hex implant! Apparently, even Nobel Biocare/Steri-Oss disagrees with you about the desirability of an external hex implant. Steri-Oss had to copy my patented design in order to meet the demands of discerning dentists. Even Nobel Biocare's Branemark line (Mk III and Mk IV) feature the Stargrip™ internal wrench-engaging design that infringe my patents. These implants no longer need to attach a fixture mount, because they have an internal, six-sided surface within the external hex extension. Core-Vent offered this feature dating back to 1982. Fixture mounts that can be used as transfers, temporary abutments and even final abutments, as offered in Paragon products, certainly offer advantages in time and cost savings that you apparently do not recognize. Paragon does offer many design options, but they target different markets, which eliminates potential confusion in implant selection. For example: 1. Paragon makes an external hex implant, the Taper-Lock™, which features a patented tapered external hex. To reduce product confusion, this implant is available in three diameters, but all share the same platform. Consequently, only one set of abutments, analogs, healing collars and transfers are needed. This implant system is targeted to the low-priced market ($124 with orders of 15 implants), and to those dentists still unwilling to change to better connections. Paragon's external hex is tapered to provide a friction-fit with the abutments, which is why Paragon can offer a 5-year guarantee against screw loosening. 2. Paragon offers the one- or two-stage Advent implant, which features a 3 mm-long neck extension that can be used as the abutment for screw-retained restorations. 3i and Steri-Oss advocate one-stage procedures, but then must sell you a healing collar to convert their two-stage implants. 3. Paragon offers several designs of two-stage implants with internal hexes that target specific preferences in surgical protocols. If one prefers a push-in implant, the Bio-Vent® cylinder and the Micro-Vent2™ ledge implant are available. The most popular design in our internal hex implant line is the Screw-Vent®, with a 14-year history on the market. A new version is just now becoming available that has the same tapered body and triple lead threads as the AdVent™ implant. This tapered design is inserted into a straight hole, which expands and compresses the bone for greater initial stability. 4. Paragon now offers a clone of the Straumann synOcta® implant with fixture mounts that are used both as transfers and as final abutments (see http://www.straumann-clone.com). To simplify the selection process, Paragon offers a free, interactive click-to-chart order program that allows the dentist to get right to the system he or she wants and select the surface, diameter and length options available for that system. The program then prompts the user through the selection of abutments, healing collars, transfers, analogs, drills, etc., specific for the selected implant design and platform. If you think options are a disadvantage, you certainly must not like Dell, Sony, Toshiba or any of the computer companies that allow customers to custom design their computers through an on-line ordering. They literally provide thousands of configurations to suit each customer's needs. Paragon is the only implant company that also has shopping cart online ordering. You list no disadvantages to Straumann's internal conical connection under your review of their system. You do acknowledge the inability to make a transfer impression as a disadvantage with conical connections -- and yet you claim "all of the root-form implants are created equal." Straumann certainly recognized this disadvantage and recently introduced its new internal octagon synOcta® implant and abutment system in Europe. Although they now sell some sizes of this implant in the U.S., they have no abutments or transfers available. They have delayed the launch of this new prosthetic system in the U.S. due to current litigation for infringing my internal wrench-engaging patent. Paragon sells a full line of SwissPlus™ abutments and transfers that fit ITI® synOcta implants. These abutments eliminate the esthetic limitations and complicated impression procedures caused by having the top of the ITI implant be the margin of the restoration. You list In nova and Lifecore as having the "Greatest Surface Area of the Group." Although Innova advertises that its beads offer increased surface area, I doubt that this is true when compared to threaded implants with blasted surfaces. More importantly, very little of the surface of the beads make initial contact with bone to provide the optimum interface for osseointegration. When bone recedes, exposed beads may become a soft-tissue problem. This was documented in their early animal studies in which approximately 50% of these implants failed in dogs due to infection. An unthreaded, tapered implant offers the least opportunity for the initial stability that is so important for osseointegration. This initial stability is absolutely vital for one-stage implants. Lifecore offers implants coated with TPS and blasted with tricalcium phosphate (RBM™ ;). Paragon offers these surfaces as well, but we have eliminated TPS on our newer implants because the blasted surface has been demonstrated in histological studies to provide an increased percentage of bone contact compared to TPS. Studies clearly show that blasted surfaces and HA-coated surfaces have a significantly higher percentage of bone contact than machined surfaces. You do not state your basis for claiming that there is no difference in clinical results with different implant surfaces. Straumann is switching from TPS to SLA (blasted and etched) due to soft tissue complications from TPS exposure. Finally, under 3i, you list them as an "excellent company to deal with." You make no mention of the limitations of using their Osseotite® surface implants that are even smoother than the Branemark machined surface. 3i did offer an internal hex, small-diameter implant, which Lazzara, the president, described in a published article as being the best connection for small diameter implants. Following patent litigation, 3i developed a small diameter external hex implant to replace their internal hex implant. If you think 3i is an "excellent company to deal with," you must like false and misleading marketing tactics. I have addressed this issue both in my Controversies literature review, available in hard copy and downloadable from Paragon's website: An editorial appeared in JOMI criticizing 3i for misleading extrapolations. Considering the difference in clinical success in the VA study between smooth (acid etched) and rough (HA) surfaces, I predict that the Osseotite surface will prove to be even less successful in soft bone than the rougher Branemark surface. To become better informed about 3i's misleading advertisements and to see SEMs of their Osseotite surface in comparison to the machined neck of the same implant, review: ../research/controversy/contro1_pt07-3.html ../research/controversy/contro1_pt08-1.html ../research/controversy/contro1_pt04-1.html
I hope this has been helpful in educating you to the fact that not all implants are created equal. I understand that it is difficult for old dogs to learn new tricks, but given the presence your website has as a reference source, you owe it to your professional colleagues to get more information before you voice your opinions. I will be happy to work with you to point out the features and benefits of each system without listing the negatives of any, and leave the consumer to make up his or her own mind as to what is important.
Q: The closest clone to Straumann's ITI implant that I have seen is the one-stage implant from Lifecore Biomedical. It allows the ITI and Lifecore prosthetic components to be interchanged. Surgeons tell me that they also interchange the surgical components. Are the ITI clones on the market are really clones, or merely copying the idea of a solid fixture that has no abutment connection until it reaches the superior portion of the biological width of the gingival tissue?
A: Lifecore's implant is a clone of Straumann's outdated ITI implant without the internal octagon. 3i's TG Osseotite® also clones this old platform. Straumann has switched the design of its platform to a new design they call the synOcta® implant. It takes the same Solid Abutments, but also has an internal octagon for transfers and some abutments. Since the internal octagon design infringes Core-Vent/Paragon's patent, and both 3i and Lifecore have agreed in lawsuit settlements not to infringe. Today, only Paragon is making the clone of the new ITI platform. Straumann is selling some sizes with the synOcta platform in the US, because that is what their production has switched to, but is not selling any transfers or abutments for this new platform, due to ongoing patent litigation with Paragon Implant Company. Paragon's SwissPlus™ ; implant is completely compatible with Straumann's Solid Abutments and Octabutments, as well as the abutments sold in Europe for the synOcta implants. Furthermore, Paragon's SwissPlus abutments and transfers fit Straumann's synOcta implants, which provide the prosthetic flexibility that Straumann promises in its website, but fails to deliver in the U.S. The SwissPlus is packaged with a fixture mount that engages the octagon and covers the external shoulder of the implant platform. This component is designed to be used as a transfer, and can be shortened for use as an abutment. In addition, the SwissPlus is packaged with a 2 mm Surgical Cover Screw. The SwissPlus implant, combination Fixture Mount/Transfer/ Abutment and 2mm Surgical Cover Screw together represent a 60% savings compared to Straumann's implants abutments, cover screws and transfers. Unlike the synOcta, Paragon's SwissPlus implant is a also features a tapered apex with vertical cutting grooves for self-tapping insertion. For more information on the SwissPlus implant, visit: http://www.straumann-clone.com
Q: Why do you state that Bicon does not have an indexing device? They do. I've used it many times and it allows for the indirect preparation of the abutment. A: As you know, the Bicon implant does not have a hex, octagon or slots that can be used for indexing. The manufacturer may advocate the use of an acrylic occlusal index as a makeshift method of transferring, but this requires extra time and is less accurate than traditional transfer techniques. It is necessitated by the design of the implant-abutment connection, which is a round, tapered hole that accommodates a round, tapered post.
Q: The Bicon implant is placed below the crestal bone. This seems to have no affect on the success of the implant. What possible objection can there be to this technique? A: While it may not affect success, subcrestal placement of the Bicon implant is an aberration of accepted implant placement protocol. It is necessitated by a need to address the esthetic limitations of Bicon's post-hole connection. Subcrestal placement is required in order to drop the abutment's height of contour as close to the crest of the ridge as possible. Implant-abutment connections that seal the outer periphery of the implant will allow the abutment's emergence profile to come directly off the implant, just as crowns of natural teeth come off of the roots. This implant design allows preparation of the margin down to the top of the implant for esthetics. There is no need to drop the implant below the crest, because the abutment's height of contour can be simply be lowered.
Q: Some people claim that you have to cut away crestal bone at the second-stage surgery with the Bicon implant. Why would you have to do that if you placed the implant correctly? A: There is a reason why Bicon makes ridge-contouring surgical instruments for use at the time of abutment placement. If you follow the manufacturer's directions, you will sink the implant 3-5mm below the crest of the ridge, then use the ridge-contouring tools to remove crestal bone at the second-stage surgery. This is done in order to allow seating of the abutment with its height of contour as close to the crest of the ridge as possible. If the abutment hits the crest of the ridge before it fully seats into the tapered hole of the implant, the necessary frictional connection between the components will not be achieved. By lowering the abutment's height of contour, the margins of the restoration can be placed subgingival with an allowance for subsequent soft tissue recession. This is a further attempt to overcome the hourglass emergence profile of the Bicon system.
Q: There is a single-stage technique with the Bicon implant. I use this approachin at least 60% of my cases. What drawbacks do you see with this technique? A: Of course, adding a healing cap to project through the tissue will maintain the opening during the healing period. However, communication from the top of the healing cap to 3-5mm below the crest of the ridge could contribute to bacterial infection, and an undercut could become a plaque trap. A true one-stage implant seals the crest of the ridge and has a neck extension on the implant that protrudes through the tissue. The implant-abutment junction is also above the crest, which is certainly better than below the crest of the ridge, as with Bicon.
Q. Most modern implants will integrate, so I don't have a problem with other systems. It's just that I prefer the Bicon implant because it is easy to restore. Why shouldn't I favor the Bicon implant since it works well for me? A: There are many systems that are much easier to restore than Bicon. Do not confuse simplicity with simplistic. The Bicon System has been around since the late 1970s and there is a good reason it has never really been very popular. Give yourself a break and try a system that more closely replicates a missing tooth. That will allow direct or indirect preparation of the abutments with placement of subgingival margins, regardless of subsequent gingival recession. Also, try a true one-stage system, such as Paragon's Swiss-Plus™ ; that comes with a fixture mount that also serves as the transfer and as a preparable abutment. Implant dentistry doesn't get much simpler or economical than that, either from a surgical or prosthetic standpoint.
Q: I see from your web page that you voice your criticisms to a wider audience than Bicon users. Don't you think this is unwise? A: I don't know if it is wise or not to widely voice my criticisms of systems like the Bicon. I can tell you that for 18 years I have been the implant industry's loudest voice in pointing out the limitations of various designs. The industry seems to now be following my lead with internal connections, use of stronger metals, rougher surfaces and stable connections. Undoubtedly I have met some resistance from dentists who were slow to change. My professional and commercial responsibility is to point out the advantages of the systems I have developed. To do that, I must openly evaluate them against the competition. It is up to you to decide if you agree with my logic and want to make a change, or if you want to stick with the system you bought and know how to use. THE QUESTION IS: HOW MANY COMPROMISES ARE YOU WILLING TO ACCEPT IN ORDER TO STILL CALL THE SYSTEM "SIMPLE AND VERSATILE"? By way of example, there are golfers who first learn to play with stainless steel clubs and wood drivers, and they will not change. Today, they cannot compete in distance with golfers using graphite shafts and metal-headed drivers. While their accuracy may be as good, they are hitting 5-irons into the same greens where the others are hitting 8-irons. The shorter the approach shot, the more accurate the shot will generally be. By the same token, the more surgically and prosthetically friendly a system is, the greater your clinical success will be.
Dear Doctor:
I understand the resistance to change that comes after working with a system for a long period of time. There are some very compelling financial reasons why you should keep an open mind about switching from 3i to Paragon's external hex Taper-Lock implant or from Straumann's ITI® implant to Paragon's SwissPlus™ ITI clone. Both of these Paragon implants also offer significant cost savings and clinical advantages.
I recently compared the price for a single tooth replacement with 3i implants and abutments and was surprised to see it could be as much as $436 higher than with Paragon’s Taper-Lock external hex implant or SwissPlus ITI clone.
3i
SURGICAL COSTS
RESTORATIVE COSTS WITH 3I SYSTEM
You can use 3i’s titanium screw for $36, but they recommend the gold screw to hold parts together. Clamping forces are critical with an external hex connection because the screw takes the lateral load (except with Paragon's external hex implants that feature friction-fit connections -- guaranteed for 5 years against screw loosening).
This is needed because the abutment’s pre-machined margin cannot hold back the tissue without it. Cost of 3i's STA single tooth abutment is $188 plus $70 for gold cylinder = $258 vs. $144 for the Prep-Tite 3i abutment for an additional cost of $114. TOTAL COST FOR SINGLE TOOTH REPLACEMENT WTTH 3I OSSEOTITE: With a preparable Prep-Tite abutment: 255 + 49 + 98 + 42 + 46 + 12 = $502 With an STA abutment: 255 + 49 + 188 + 42 + 70 + 12 = $616
IMPLANT AND RESTORATIVE COSTS WITH PARAGON’S SYSTEMS External Hex Taper-Lock Implant: Total cost using Paragon's Taper-Lock external hex 4.7mmD implant, made of work-hardened Grade IV titanium (2X stronger than 3i), with SBM-blasted surface, triple lead threads, friction-fit tapered external hex and fixture mount/transfer/temporary abutment packaging = $125
Preparable Straight Abutment in 3 Emergence Profiles = $55. Using abutments without shoulders not only eliminates the need to select the appropriate gingival cuff height for an abutment, but allows surgeons to attach the abutment at second-stage to maintain the tissue opening. TOTAL COST FOR SINGLE TOOTH REPLACEMENT WTTH PARAGON: Taper-Lock
cost for single tooth replacement = $125 + 55 = $180 PARADIGM SHIFT IN THE TEAM APPROACH Surgical specialists who want to build their implant practices are now attaching the abutments for their restorative dentists. Others are providing the GPs with the restorative components. This saves the GP from having to read a 100-page catalog to find the correct emergence profile transfer and abutment. Even if the restorative dentist is knowledgeable in implant reconstruction, the cost of the components impacts the GP’s profitability and ultimately effects the number of cases the dentist will send you. For these reasons, the cost and complexity of the restorative components should be considered by the surgical specialist when selecting an implant system. Attaching the abutment by the surgeon at the second-stage surgery eliminates the cost of buying a healing collar and saves the restorative dentist both chair time and abutment expense. The restorative dentist will now only need to complete the preparation intra-orally and make a conventional impression. The Taper-Lock’s fixture mount is designed for use as a transfer, which facilitates stage-one transfer impressions by the surgeon in the esthetic zone. This will allow the indirect preparation of an abutment and fabrication of the temporary restoration for attachment at second-stage surgery. This saves the cost of transfer transfer components and healing collars while establishing the ideal emergence profile healing of the soft tissue. The fixture mount of the Taper-Lock implant is slightly tapered so that it can be shortened for use as a temporary abutment. The fixture mount on the SwissPlus is designed not only for use as a transfer, but also as the final preparable abutment. Cost savings with Paragon products comes from fair and multifunctional packaging components.
WHY PAY MORE AND GET LESS WITH 3i OR STRAUMANN PRODUCTS. While I know that price alone is not a deciding factor in selecting an implant system, when one is paying so much more and getting so much less for 3i, then it is time to reconsider the choice of implant systems. Similarly, Paragon’s SwissPlus ITI clone represents a 60% cost savings compared to buying the components separately from Straumann. It also offers additional benefits, such as full-contour, preparable abutments, self-tapping insertion and simplified restorative procedures. FOR MORE INFORMATION ON TAPER-LOCK AND SWISSPLUS VISIT www.branemark-clone.com for the Taper-Lock advantages www.straumann-clone.com for the SwissPlus advantages Visit www.paragon-implant.com to see the many advantages of the Tapered Screw-Vent and Advent implants and to see how easy and inexpensive it is to set up a website for your office and your referring dentists (select Web Site Design Center on our homepage). Imagine the referrals you would get if you bought a website for all of your restorative dentists. The cost is only $200 for each website, less than the savings you will realize every time you use a Taper-Lock or SwissPlus implant compared to 3i, Straumann or Nobel Biocare costs OSSEOTITE SURFACE IS SMOOTHER THAN A MACHINED SURFACE 3i made a number of false claims about its Osseotite surface being rougher than a machined surface. In fact, SEMs and 3-D surface topographic analyses of the Osseotite surface published by Calcitek, Steri-Oss and others clearly show that it relatively smooth. Paragon’s website posts side-by-side SEMs of the machined neck of the Osseotite and its acid-etched body, which demonstrates that the acid-etched Osseotite surface is smoother. A study by Buser compared the Osseotite etched surface to the SLA blasted-and-etched surface and documented about half the torque removal strength for the smoother Osseotite.
SURGICAL PREDICTABILITY AND EARLY LOADING CLAIMS Both 3i and Straumann make marketing claims that their surfaces allow earlier loading, but they have no documented comparison studies of implants with and without their surfaces. Straumann’s claims are supported by animal studies that either make the comparison to a machined surfaces, or show no statistical difference with TPS surfaces. 3i supports its claims by citing animal studies, most of which were not even conducted on the Osseotite surface. The published research from many sources confirms that HA coatings offer stronger and faster bone attachment. Two recent studies, however, showed that Paragon’s SBM-blasted surface produced the same, if not a slightly higher, percentage of bone contact compared to HA coatings. RESTORATIVE PREDICTABILITY AND SIMPLICITY The stability of the implant abutment- interface should be a serious consideration in selecting your implant system. Paragon stopped selling acid-etched implants because its V.A. multicenter study, which compared 1100 acid-etched implants with 1700 HA-coated implants, showed a significant advantage for HA, especially in soft bone and in the hands of less experienced clinicians. DISCERNING DENTISTS CHOOSE PARAGON FOR VALUE AND FEATURES.
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