Report on Failures of Immediate Loading of None-Expandable Implants (Nobel Biocare)
This report demonstrates the results of trying to immediate load Screw implants that have no ability to expand to achieve initial stability. The traditional implant manufacturers after trying to copy the Sargon implant and failing due to its patented design, resorted to a mass marketing campaign to show that traditional screw implants can be immediate loaded. This report demonstrates their failures.

WATCHFUL WAITING: One-Piece Dental Implant Inertia 

As greater public attention is paid to oral aesthetics, patients are increasingly demanding procedures to improve their smiles. Reality TV shows such as Extreme Makeover are spreading the popularity of these "quick fix" procedures. One industry source states that "the single biggest factor [for industry growth] has been the TV shows and increased cosmetic awareness. The restoration can't just be good enough, it has to be beautiful." In order to satiate the public desire for immediate and effective procedures, dental implant manufacturers developed several techniques and products to accelerate the implantation process. Promoted as a fast option for functional teeth, one-piece dental implants are one of these solutions. One-piece manufacturers are swaying aesthetically conscious clients with promises of new, beautiful, serviceable teeth. By combining the titanium implant and abutment, one-piece implants enable both components to be implanted simultaneously. As such, patients can have fully functional teeth within a matter of days, not months.

In a country where convenience and beauty are prized qualities, one-piece implants appeared destined to succeed. The US one-piece implant market has, however, encountered significant obstacles. Current allegations of bone loss, regardless of their veracity, have stunted the US market. Growth will occur over the next five years, but at an annual rate below that of the overall dental implant market.

Watchful Waiting

Counter claims

The US dental implant market underwent significant fluctuations after the initial release of one-piece dental implants in 2004. Possessing a design and functionality consistent with the American demand for immediate and aesthetically pleasing dental solutions, the new technology seemed a perfect fit for the US market. The excitement that followed the release of these devices led many to conclude that one-piece implants represented the future of implantology. The one-piece dental implant is not, however, a novel concept, having existed in various forms since the 1950s. The early one-piece implants were both controversial and ultimately unsuccessful. Some industry sources suggest that marketing campaigns have blinded people to these past failures. Indeed, complications and unfavorable results from recent studies have dampened interest in the latest devices, causing the market for one-piece dental implants to come to a virtual standstill. Several class-action lawsuits have been launched against Nobel Biocare (Goteborg, Sweden), the maker of the NobelDirect one-piece implant and leader in the dental implant market. Additionally, professors at Goteborg University in Sweden have alleged that patients who receive one-piece implants experience increased bone loss. Nobel Biocare has roundly denied these allegations.

In May of 2005, the Goteborg professors demanded that the NobelDirect be withdrawn from the market. Because Nobel Biocare refused to comply, citing its own clinical studies which revealed no evidence of bone loss, the professors went public with their claims on Swedish national TV. The case has garnered a great deal of attention from the medical and financial fields, ensuring that the implications of the dispute play out in the US market. In 2005, one-piece dental implants generated approximately $19 million in US revenues. Thanks to the controversy, the market is growing at a much slower rate than originally anticipated following device release in 2004. Unless concrete clinical results confirming the benefits and efficacy of one-piece implants are published, growth will remain conservative, allowing the market to reach just over $50 million by 2010.

In response to the allegations, Nobel Biocare released a substantial body of clinical data, demonstrating a 98.3% success rate for its one-piece implant. After examining the claims of the rival parties, the Swedish Medical Products Agency decided not to take action against Nobel Biocare, citing a lack of conclusive evidence. The Swedish authorities have, however, noted the considerable difference in the data presented by the two parties. The Goteborg professors claim their results show bone resorption in excess of 3 mm in 20-30% of cases, but have yet to release this data despite repeated requests from Nobel. Inevitably some physicians are now questioning the need for a one-piece dental implant; many doctors familiar with two-piece delivery feel that expediting the procedure is unnecessary and potentially damaging to the patient. While the controversy surrounding the NobelDirect a device that accounts for only 2% of Nobel Biocare's total sales—is unlikely to have a significant impact on corporate revenues, it remains to be seen whether this situation will adversely affect the marketability of the company's other dental implants.

Profit Potential

Although the one-piece dental implant segment appears to have reached an impasse, the overall US market for dental implants will continue to grow at a rapid rate thanks to consumer demand for immediate and aesthetically pleasing dental solutions. Dental implants are associated with

everything from improved comfort and value to appearance and self-esteem, prompting widespread consumer demand and overall market growth approaching 30% over the past two years. Driven by the the trend towards more immediate and aesthetically appealing solutions, the US dental implant market will exceed $400 million in 2006.

As aging baby boomers become more susceptible to tooth loss, the dental implant market will continue to expand. Seniors are particularly intent on procedures that are convenient, swift, and provide aesthetically pleasing results. Manufacturers will benefit from the fact that many baby boomers also possess the financial resources to make such purchases. Last year, the average selling price (ASP) for units in the overall dental implant market, was approximately $200. By contrast, one-piece dental implants commanded an ASP of approximately $300. Because patients pay upwards of $1,000 per implant placement, only those willing to incur this cost will receive one-piece implants. The elevated cost of one-piece implants is chiefly due to Nobel Biocare, which prices its implants at a premium. If physicians accept the clinical data published by Nobel Biocare and adopt the NobelDirect, the company stands to profit.

The effect of the Nobel Biocare's efforts to exonerate its product has yet to be seen. Although the company has been diligent in its attempts to address any lingering concerns over the NobelDirect, some doctors who perform implantations are voicing frustration with the company, suggesting that the quest for profits has blinded Nobel to patient needs. Others suggest that while the company's products are reliable, physicians require more comprehensive training to ensure proper implant placement and alignment. Nobel Biocare's chief competitors, Straumann (Basel, Switzerland), 3i (Palm Beach Gardens, FL), and Zimmer Dental (Carlsbad, CA), are no doubt watching this story as it unfolds and reevaluating their market strategies accordingly.

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