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US ban on Biora Products costs Straumann 10 million Swiss Francs

The continuing FDA ban on importation of Biora`s Emdogain and Bone Substitute has cost parent company Straumann 10 million Swiss francs (8.14 million US$). Straumann chief executive Gilbert Achermann described the loss as `painful`. He furthermore stated that `The US FDA will reinspect our facility in Malmo, but we are not in a position to say when this will happen, If all goes well`, Biora products `could be reintroduced in the US in the first quarter of this year,` Additionally,

Nobel Biocare`s Ti-Unite to feature BMP-2 coating

Swiss implant manufacturer Nobel Biocare has signed an exclusive agreement with Wyeth Pharmaceutical manufacturer of Bone Morphogenic Protein rhBMP-2. They claim that: `TiUnite(r) will serve as the foundation for the next generation of dental implants with the potential of eliminating the need to graft and use of membranes. Nobel Biocare is currently in clinical testing of an implant designed to create its own bone. This implant will be treated with a bone morphogenetic protein rhBMP-2 (a recombinant version of a

Novartis acquires 10% stake in Thommen Medical

Novartis, the Swiss pharmaceutical giant has taken a 10% stake in Swiss dental implant manufacturer Thommen Medical. According to a press release, Novartis`s stake will rise to 20% later in the summer. Andreas Stutz, Thommen Medical CEO says: “Novartis is a strategic partner for us. This opens completely new possibilities in the area of research. The understanding of soft-tissue and bone biology becomes more and more important for the producers of dental implants. Furthermore, we see the interest of Novartis

Straumann Twist Drill Pro

Straumann has updated their wide diameter implant twist drill design with a rounded apical profile ending in a flat tip to allow for more accurate osteotomy preparation. They claim that `the rounded flat-end tip facilitates safe drill positioning and ensures secure drill centering in the implant bed. The defined direction is maintained throughout the entire drilling process.`

Nobel Biocare responds to Swedish Medical Products Agency`s marketing ban on NobelDirect

Nobel Biocare has released a response to the recent marketing ban in their NobelDirect implant following reports that it lost an excessive amount of bone following placement. The response called the initial report to the Swedish Medical Products Agency (SMPA) on NobelDirect by Dr Albrektsson as `… incomplete and reported in an unscientific way. The analysis of the present manuscript shows that the material still suffers from intransparency and lack of scientific stringency. The process for peer-review may even be

Trinon`s Short Q-Implant

Trinon has designed a series of extremely short, but wide implants designed for use in areas of limited alveolar height. This design is appropriate for severely atrophied, but wide lower and upper jaw architectures. Insertion is via trephine use and are very appropriate for internal sinus lift use. The implants range in size from 4mm to 7mm in height.

One Minute Extraction – Physics Forceps

GoldenMisch has developed a set of extraction forceps. Its design delivers a powerful mechanical advantage by employing an efficient first-class lever. The forceps feature a bumper which is set low on the alveolar ridge, perpendicular to the tooth, creating a good fulcrum point. The Physicsforceps makes only one point of contact with the tooth, as opposed to conventional forceps that work like pliers. The website shows various testimonials and animation of the `rolling` extraction technique.

Faciliate 1.0 from AstraTech

Astratech has released a customized version of Simplant for use with their implant system. The software program also contains 3D images of implants, abutments and teeth. This ensures efficient, accurate and reliable planning of implant positions, sizes and number of implants, and abutments to be used. In addition it provides better control over the esthetic outcome. When the case is planned, a surgical guide is ordered to make sure that the planning result will be replicated in the real surgical

Controversy over the high price of Dental Implants

Dr. Gerald Niznick of Implant Direct sent a letter to the Editor of IJOMI taking issue with its recent Editorial (JOMI 2006; 21:6) that claimed a direct correlation between innovation and high prices for dental implants. Dr. Niznick`s letter analyzes the published financial statements of Nobel Biocare and Straumann showing their cost of goods at 16% to 20% with marketing expenses in excess of 40% and research costs of only 3.5% – 5% of gross revenues. The editor saw fit

Socket Repair Membrane

Zimmer`s Socket Repair Membrane is a specially shaped collagen membrane designed to assist wound healing in alveolar facial plate repair and residual ridge preservation following atraumatic, flapless single-root tooth extractions. It is pre-cut to fit single root sockets, saving the clinician time and limiting waste. The membrane contains graft material by capping the socket with the circular portion of the membrane and helps retain the post extraction buccal wall preventing the bone particles from dispersing into the tissue and preventing

Robotic Smart Drill

A robotic smart drill developed by Aston University(UK) and clinically tested at the University Hospital Birmingham offers a more precise means of drilling. Tested in a cochlear implant procedure, the device is able to detect the approach of the drill tip as it approaches this tissue interface. It is then able to avoid penetrating the membrane, so avoiding drilling and other debris dropping into the ear. It is expected that this more precise means of drilling will lead to improved

Implant Guidance System

Innovative Implant Technology has released an innovative kit to aid in the planning and placement of dental implants in a variety of clinical situations. It features colour-coded `measuring blades` that aid in determining the optimal implant size for a particular edentulous space. The measuring pins are used during placement to ensure optimal implant-tooth and implant-implant spacing.

Straumann acquires Etkon for 100 milion euro

The friendly takeover is Straumann`s largest to date and will position the group as a “one-stop shop” by providing solutions such as bone augmentation as well as implants and prosthetics, the firm said. “Overall it is a positive strategic move. They are copying the strategy of other major competitors, such as Nobel Biocare, by providing both implants and prosthetics,” said Vontobel analyst Christoph Gubler. Straumann has struggled to match Nobel`s presence in the U.S., where fewer dentists have used implants

Biomet / 3i launches Nanotite Implant

Biomet / 3i has released their upgraded surface, Nanotite. Nanotite features their previous Osseotite surface treated with discrete crystalline deposition of Calcium Phosphate (CaP) resulting in a more complex surface topography. They claim that the biologic benefits Of CaP may play a key role in enhanced site response, potentially improving clinical predictability and outcomes. – This surface is named the same as one released by Bicon a few months ago, are they the same?

Self-Regeneration of Teeth with the Wnt Pathway

Researchers from the Institute of Biotechnology at the University of Helsinki and their collaborators from Berlin and Kyoto have now shown that continuous tooth generation can be induced in mammals. The research results were published in `Proceedings of the National Academy of Sciences,` (PNAS). The researchers activated the Wnt signaling pathway in mouse tissue; this signaling pathway is one of those used for cell communication and plays an important role in embryonic development. As a result of stimulating this particular

Nobel Biocare refutes criticism concerning its teeth-in-an-hour dental implant

Nobel Biocare refuted criticism voiced by Swedish scientists, saying its implant product `teeth-in-an-hour` is a scientifically proven concept with high success rates. The Swiss-Swedish implant maker said that one of its `ongoing studies with 19 patients and a total of 118 implants shows that after three years, 96.3 pct of all implants still function`. The complete report will be available in April, it said. The group`s statement came in reaction to a study by Sweden`s Karolinska Institute published on Saturday

`Teeth-in-an-Hour` may carry more complications than conventional methods

Swiss-Swedish Nobel Biocare`s Teeth-in-an-Hour implant system may carry more risk of complications than conventional methods, an abstract of a study by Sweden`s Karolinska Institutet showed on Saturday. The study examined 31 patients treated using the method, which uses computer modeling to reduce implant installation time and showed that complications such as the loss of fixtures and the need for adjustments arose for nearly a third. Nine percent of the 175 fixtures examined were lost, said Bjorn Klinge, professor of periodontology

ITI Treatment Guide Vol-1 Published

Straumann’s academic partner, the International Team for Implantology (ITI), introduced the first Volume of the ITI Treatment Guide in cooperation with Quintessence publishing. Volume 1, entitled `Implant Therapy in the Esthetic Zone – Single-Tooth Replacements` was introduced to the professional community at the EAO’s 15th Annual Scientific Meeting in Zurich.It takes its readers through the entire process, starting with the assessment of the patient’s individual esthetic risk profile and proceeding to through ideal three-dimensional implant placement and proven prosthetic management

Drug Delivering Prosthetic Implant

The Fraunhofer Institute for Biomedical Engineering IBMT in Germany have developed a dental prosthesis consisting of a drug-filled reservoir, a valve, two sensors and several electronic components. Saliva enters the reservoir via a membrane, dissolves part of the solid drug and flows through a small duct into the mouth cavity, where it is absorbed by the mucous membranes in the patient’s cheeks. The duct is fitted with two sensors that monitor the amount of medicine being released into the body.

GEM 21S – Recombinant human platelet derived growth factor (rhPDGF-BB)

Osteohealth`s GEM 21S is a wound healing and bone regeneration technology termed growth-factor enhanced matrix (GEM). It has recently become available for clinical use. This graft material consists of a concentrated solution of pure recombinant human platelet-derived growth factor (rhPDGF-BB), the synthetic form of the body’s key natural wound healing stimulator PDGF-BB, and an osteoconductive (bone scaffold) matrix. This is the first available purified, recombinant (synthetic) growth factor product and is the result of over a decade of extensive research.

Stem Cells used to Regenerate Dentin and PDL in a HA Implant

Using stem cells harvested from the extracted wisdom teeth of young adults, researchers have successfully generated tooth root and supporting tooth ligaments to support a crown restoration in experiments using miniature pigs. The restored tooth mirrored the original tooth in function and strength, the research team reports in the December issue of the open access medical journal PLoS ONE. The technique holds promise for use in humans, the investigators say. Dr. Songtao Shi said: “In this study, we use stem

Sweden`s MPA restricts sale of NobelDirect and NobelPerfect

The Swedish Medical Products Agency investigation of the dental implants NobelDirect and NobelPerfect show that there can be deficiencies in the instructions for use for the products.The MPA decision directs Nobel Biocare to clearly describe possible causes for the breakdown of the jawbone in the instructions for use and training programs. In addition, the company must describe how the risk for breakdown can be avoided. In sales and promotion information and instructions for use, the company shall indicate the user

FDA sends `Warning Letter` to Straumann`s Biora

In the course of a routine inspection of Biora AB, Straumann`s oral regenerative product company in Sweden, in October 2006, a U.S. Food and Drug Administration (FDA) investigator made a number of observations predominantly concerning maintenance of quality system documentation and procedures associated with the company`s products. Biora has received a “warning letter“ from the FDA, which indicated that its “dental bone grafting materials“ are on import detention in the U.S., until the inspectional observations are resolved. No other countries

FDA Approval: Recombinant human bone morphogenetic protein-2 (rhBMP-2)

Medtronic recently announced that the FDA Dental Products Advisory Panel has unanimously voted to recommend approval, with a condition the use of INFUSE® Bone Graft for certain oral and maxillofacial bone grafting procedures. INFUSE Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. It has been previously approved by the FDA for use in certain lumbar spine

Merrill Lynch`s Implant Industry Report

A Merril Lynch analyst`s report on the dental implant industry has been released. Issues discussed include: the risk of increasing regulation of implant placement, image guided surgery`s growing importance, Nobel Biocare`s sales strategy and various implant company`s product launches. As always, a very interesting read.

Sirona`s Galileos Implant Planning Software

Sirona have received the FDA`s 510K approval for their Galileos 3D X-ray imaging system. This system uses a Cone Beam-based technology that calculates a large volume 3D image set, more than 200 exposures, in a single low-dose 3D scan of 15 seconds or less. This 3D image set is processed and presented in the new GALILEOS software, an advanced extension of Sirona’s SIDEXIS XG imaging software.

Nobel Direct – too risky to use except with `great care`

Sweden`s Medical Products Agency has made a preliminary finding that Nobel Biocare AG`s dental implant Nobel Direct, is too risky to use except with `great care`. The regulator said it will over the next few weeks come to a final view on Nobel Direct and what eventual warnings will be attached to the implant. The agency issued its statement after investigating the results of Nobel Biocare`s own two year study and said this study was not based on a representative

Balloon Lift Control by Meisinger

Meisinger has released their balloon based sinus lift system. It uses a system of precision drills and drill guides to allow the introduction of a saline-filled balloon into the sinus. This balloon is then filled to gently push the sinus up. They report up to 10mm of lift height with minimal invasiveness.

Training Standards in Implant Dentistry for General Dental Practitioners

The General Dental Council (UK) convened a small working group in December 2005 to to consider what training standards would be necessary for a general dental practitioner before practising implant dentistry, to publish those standards and then periodically to review them in the light of developments in implant dentistry. Such standards could be used not only by practitioners but also by the GDC in the consideration of patient complaints against dental practitioners who, allegedly, practise implant dentistry beyond the limits

Implant Direct – Dr Niznick Returns

Implant Direct LLC has received a FDA 510(K) Marketing Clearance for their Spectra System. Dr Niznick, inventor of the internal anti-rotational connection, has started his own dental implant design and manufacturing company that employs a web-based order and support model to deliver a versatile line of implants at about 50% of the price of the major manufacturers.

Cresco(r) – Passive fit on screw-retained implant bridges

Astratech has released their Cresco(r) system for ensuring passive fit on screw-retained implant bridges. This system allows for up to 17 degrees of angle correction for screw-retained bridges using bendable wax tubes giving maximum flexibility in terms of being able to compensate for angled implant placement when bone quality and quantity are poor. Using a Cad-Cam-like milling machine corrects the casting distortion of prosthetic superstructures to a very high degree of precision. The majority of implant systems are supported.

MIS Crest Widener Kit

MIS Implant Technologies Ltd has released a Crest Widener used to widen a narrow alveolar crest which has sufficient height for implant placement. The cortical plates are separated and the crest widener distracts the plates so that new bone is created between the plates and the attached gingiva. They have a step-by-step guide and video of the surgical technique on their website.

NIH funded study on Osteoporosis and Implants

The University of Connecticut Health Center has received a five-year, $2.6 million grant from the US National Institutes of Health to study the relationship between osteoporosis and the success or failure of regeneration and dental implants. They plan to recruit 120 women for the study. Specifically, the study is designed to help the researchers develop a reliable estimate of the two-year success rate of bone augmentation and dental implants in women with broadly varying bone density measurements.

Straumann`s Hydrogel-based Membrane

Preclinical results were presented recently at the EAO meeting for Straumann`s innovative hydrogel-based membrane, which confirmed the product`s efficacy and ease of handling. The first clinical trial was successfully completed in the third quarter, with each of the endpoints being met. On this basis, applications for regulatory clearance should be submitted in the current quarter. Straumann and Kuros Biosurgery, a spin-off from the Swiss Federal Institute, ETHZ and the University of Zurich, applied for a patent on this technology in

Ghouls in the Mortuary – A Halloween Story

The perils of living in New York go beyond the grave. The directors of seven funeral homes have been stripped of their licenses and face jail after pleading guilty to their role in what one US official called “the crime of the century” – whenever they got hold of a suitable corpse, they would tip off a team of illegal body harvesters led by Michael Mastromarino, a former oral surgeon who had lost his dentist`s license. Operating out of a

NobelDirect – Verdict delayed

Sweden`s Medical Product Agency (SMPA) has announced it will delay its final verdict on the safety of Nobel Biocare AB`s dental implant NobelDirect, which is alleged to cause bone-loss, until November. The agency cited a delay in the release of Nobel Biocare`s two-year follow-up study as being responsible. Two Swedish dentists in May 2005 alleged that the product is causing bone-loss, prompting investigations by the heathcare authority.

NanoTite – HA splutter coated titanium surface

Bicon have developed a new surface process, NanoTite™. A high-energy ion beam source aims a beam of ions at the surface of a target treated with HA. These high-energy ions eject the HA from the target/substrate and create a molecular cloud whose molecules bond with the surface of the Bicon Ti 6Al-4V ELI implant. This Ion-Beam Assisted Deposition process, which provides increased integration with the implant surface, is known as High-Energy Sputter Deposition. Using an Ion-Beam Assisted Deposition process, the

rhBMP-2 Bone Regeneration Around Implants

Ulf Wikesjö of the Medical College of Georgia has demonstrated impressive osseous regeneration around dental implants coated with recombinant human Bone Morphogenic Protein (rhBMP-2). Dr. Wikesjö is researching wound-healing and tissue regeneration with a $1.4 million grant from Nobel Biocare. In laboratory tests, rhBMP-2 applied onto implants directs endogenous stem cells to become bone-forming cells. The result was a nearly complete regeneration of lost tissue. He hopes to start clinical trials in the summer of 2006.

John Gotti`s Blade Implants

Famous mafia boss John Gotti, Dr Leonard Linkow and blade implants – all part of the history of implantology. An amazing story reported by the NY Daily News in 2002. Enjoy: Around 1988, after losing several teeth, Gotti tired of dentures and had permanent implants surgically installed and his remaining teeth capped. He visited the E. 50th St. offices of Dr. Leonard Linkow, a frank-talking New Yorker with a shock of white hair. Linkow had been famous among dentists worldwide

copgiX® A 2D planning and diagnostic system

IVS Solutions AG has released a 2-dimensional implant placement planner that uses panoromic and peri-apical xrays for the implantologist to design the type and position of the implant(s). The software then produces a surgical plan which lists the implants planned for placement as well as an image of the planned implant positioned on the xray.

PEEK Customized Healing Abutment

BEGO Implant Systems GmbH & Co has designed a customizable healing abutment designed to shape the soft tissue. By customizing the PEEK blank at the chairside the emergence profile can be shaped, elliptical or even triangular, depending on the circumferential shape of the tooth that is to be replaced. It is made of a high-strength and completely biocompatible plastic abutment made of (implantable) polyether-ether-ketone (PEEK). This material is trimmed into the required shape with the handpiece at the chairside and

Anti-Microbial Implant NanoSurface

Brown University engineers have shown that both zinc and titanium oxide nanosurfaces can reduce the presence of bacteria. Discs with nanostructured surfaces had bumps that measured only .023 microns in diameter. Discs with microstructured surfaces had bumps that measured about 5 microns in diameter. Microstructured zinc oxide discs were host to 1,000 times more bacteria than the nanostructured zinc oxide discs. Similar, but less striking, results were duplicated on titanium oxide discs. The engineer`s hypothesis is that: `with the nanostructured

Zirconium One Stage Implants

Ceraroot have designed five ziconium-based one-stage implants for use in different areas of the mouth. The anatomically designed implants incorporate the abutment into the implant for a very esthetic result. An interesting video is posted on Google Video showing the use of a Ceraroot implant in an immmediate placement procedure.