Two recent recalls by the US Food and Drug Admininstration (FDA) of Zimmer’s Trabecular Metal Technology, one in dental implants and the other in shoulder implants raise concern.
In the case of the recall of the Trabecular Metal dental implant: The Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient with a dense (Type D1), thick, inferior border. The recall correction includes adding precautions to the Instructions for Use regarding the placement of a 4.1mm Trabecular Metal implant.
While the shoulder implant recall: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint as well as humeral fractures. The humeral stem uses. Trabecular Metal around the proximal part of the stem for biological ingrowth. This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification.
Blue Sky Bio has released their BIO|Cut drill that features a unique drill topography to cut bone very efficiently without the need for sequential size drills. Only the final implant specific drill is needed to shape the osteotomy before implant placement. This design is particularly useful in guided surgery and allows very accurate guided osteotomies to be made without the need for key guides and sequential drill sizes which can introduce and compound inaccurate positioning. This system allows you to prepare your final osteotomy with only 2 drills, the Bio|Cut drill and your final implant specific shaping drill.
Tantalum, element #73 on the periodic table has found its way into dental implants thanks to mega dental implant manufacturer, Zimmer. They have tranferred it from use in hip implants to dental implants. The trabecular metal material structure and stiffness similar to trabecular bone and is fabricated by coating a vitreous carbon skeleton with tantalum through a proprietary chemical vapor deposition coating process. The tantalum exhibits a crystallographic growth on the vitreous carbon surface of the interconnecting struts that form the material. Trabecular metal technology differs from sintered bead surfaces, titanium plasma-sprayed surfaces, titanium fiber mesh and titanium foam in the high degree of its interconnected porosity (up to 80%) and the regularity of its pore size and shape. In contrast to conventional bone-to-implant contact achieved by non-porous surfaces, Trabecular Metal Technology’s geometrical network of interconnected pores is designed for biological ingrowth through the pores.
The implant’s coronal, apical and internal implant structures are made of titanium alloy (Ti-6Al-4V grade 5) with a microtextured surface created by grit-blasting with hydroxylapatite.. The coronal section features cervical micro-grooves and Zimmer Dental’s internal hex, friction-fit connection, and the apical section features self-tapping threads. In the midsection of the implant, the Trabecular Metal Material is made of tantalum (98%) over a vitreous carbon substrate (2%).
Zimmer decribes the implant as having osseoincorporation properties refering to the healing potential of bone onto an implant surface and into an implant structure. The trabecular metal dental implant features an osteoconductive mid-section, formed from the trabecular metal material, designed for ingrowth as well as ongrowth in a process new to implant dentistry—osseoincorporation.
Among the new products presented by Straumann at the International Dental Show (IDS) in Cologne, Germany is a comprehensive instrument kit for guided implant surgery. The kit contains all the instruments, drills, profilers and taps needed to place Straumann implants with surgical templates currently made with open-library (non-exclusive) 3D software systems, including IVS, Materialise, med3D, iDent, and siCAT.
Researchers at the University of Ankara, Turkey have designed an innovative CAD based implant guide. The design features a plastic stent produced by rapid prototyping methods that snugly fits the implant handpiece and uses a square slot system to guide the drill direction as opposed to the metal/plastic sleeves used by similar systems. This allows for better visualization of the surgical area and negates the use of stepped sleeves of increasing diameter to guide the twist drill. Additionally it eliminates the risk of metal shavings entering the osteotomy site.
Gendex has released its latest imaging system. The GXB-500 features a medium size form-factor cone beam CT for for implant planning, TMJ analysis, and small oral surgery procedures. The system’s unique Amorphous Silicon Flat Panel sensor yields accurate, highly detailed image quality at the fastest scan and reconstruction rates in the industry (8.9 seconds and 20 seconds respectively), that allow dental teams to experience greatly improved workflow. Adding to the value of the GXCB-500, the system serves a dual function—it also features traditional digital panoramic imaging for capturing 2-D data
Biomet 3i have developed a protocol and set of surgical instruments for use with their implants in CT guided surgery. The Navigator System utilizes a surgical plan devised from CT images using Materialises`s Simplant Technology and a combination of specially designed surgical and laboratory drills and instruments to allow template-based implant positioning and immediate restoration if so desired.
Implant Logic Systems is a service which both plans implant positioning and manufactures a custom surgical drill guide to place the implants according to the treatment plan. They use both `Simplant` and a custom software package, VIP, to plan the implant position using CT-Scan data. Their Pilot Compu-Guide Drill Kit is used to ensure accurate osteotomy positioning using the custom designed drill guide and sleeves.
Drillstops.com has released a series of drill stops designed for use with the Straumann and compatible systems. They also have an adjustable depth guide which features analogs of the narrow, standard and wide neck implant platforms allowing for a more accurate visualization of the position of the implant neck.
The gauge has been renamed `Verban Depth Gauge` after its inventor Dr. Emil Verban.
Ingenious Dentistry LLC has released a radiographic marker that features one or three precision stainless steel ball bearings sized at 5mm. These are placed at the time radiographs are taken and used to calibrate the resulting radiographic image. Their site features some good tips and explains how to calculate the actual size of the object of interest in the calibrated xray.
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.
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 saying that its Teeth-in-an-Hour implant system may carry more risk of 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 at Karolinska Institutet and one of the study`s authors.
This compared with a loss rate of roughly 2 to 3 percent using conventional and more time-consuming methods, he added.
“My assessment is that this is still at the trial stage and therefore can`t be recommended for general use,” Klinge told Reuters.
“Our data shows rather unequivocally that there is a lot of development left before one can say if this is a good or a bad product,” he added.
The study, presented at a dental conference in Venice on Saturday, has not yet been published in a scientific journal or peer-reviewed, but Klinge said an article was being prepared.
Med-3d has released a CAT-Scan based 3-D implant planner similar to many other software packages previously profiled, however they use a very unique XYZ positioning device to drill the titanium drill tube holes in the patient stent – basically a dental surveyor on steroids.
MIS Implant Technologies Ltd.`s Abrahmi Drill Guide Kit is a drill guide kit that allows for optimal inter-implant spacing, angulation and parallelism. The kit contains several spacers which the surgeon can select to determine the inter-implant distance. The device features several drill sleeves of different diameters which ensure parallelism of the implants.
Materialise`s SAFE System combines drilling guidance, implant insertion guidance and depth control. Simplant is used to plan the optimal position of the implants and then this plan is transferred to the SAFE system which produces a physical guide and a surgical report to guide the surgeon during implant placement.
Osseo Scientific has introduced an innovative autogenous bone chip collector. It features a collection cup with a bur inside the bone collection cup. As bur penetrates the bone the harvested bone chips are stored in the cup ready for immediate use. The whole assembly is autoclavable and fits a standard implant handpiece.
Stoma has introduced an innovative kit to allow for optimal implant positioning and spacing. The system consists of two sets of seating sleeves with increasing diameters, 5 fixation pins and 3 straight and angled bone spreading instruments. The seating sleeves are used to plan the optimal implant diameter for a particular surgical site. They are also useful for determing the proper interproximal spacing in areas where multiple adjacent implants are planned.
OTA`s new balloon sinus lifter allows for less traumatic hydraulic sinus lifts (internal and lateral approach) by reducing the risk of membrane tears. The micro-mini balloon inflates to 1.9mm with saline administered via a 5cc syringe. The gentle pressure on the membrane expands the sinus graft space gently without any sharp instruments.
Mectron`s piezon-electric surgery system can be used for osteotomies and osteoplasty in implantology. Additionally it can be used in periodontal, endodontic and surgical orthodontics. It`s selective cutting action allows for mimimal soft tissue damage, especially useful for opening sinus windows during lateral sinus lift procedures. This unit comes with an array of handpiece tips designed for an array of surgical procedures.
Thommen Medical has introduced their SPI MONO torque ratchet. It is manufactured from a solid billet of titanium. It has a torque range of 10Ncm to 35Ncm in 5 Ncm increments. The one-piece construction simplifies regular maintenance as there are no parts to disassemble for cleaning and no lubrication is required.
Z-Systems has introduced a completely metal-free implant and set of surgical instruments for placement of these implants made from 95% Ziconium dioxide and 5% Yttrium tri-oxide. Zirconium is one of five metals shown to support osseointegration (the others are: Titanium, Niobium, Tantalum and Platinum). This new approach has been certified for use in Germany, but FDA clearance for use in the United States is planned. A few animal and human based studies suggest that the bone-to-implant contact percentages (a measure of the degree of osseointegration) are similar to those achieved with titanium-based implants.
Kavo has introduced an innovative implantology handpiece with a fiber-optic light. This is a part of their Intrasurg 300+ implant motor and handpiece set. It also boasts a torque measuring feature to aid in immediate placement and immediate load decision making.
B.T.I. has introduced a bone expander drill set. It uses a set of four wedge-shaped bone expanders to expand alveolar bone and condense bone in sites with low bone density. The rotary motion of either an implant handpiece or a torgue wrench is used to slowly expand the bone instead of using the more traditional osteotome/bone condenser/ridge spitter and surgical mallet combination.
MIS Implant Technologies Ltd`s new compression kit improves the treatment procedures for sinus lifting and soft bone compression. A simple bone compression procedure enables better implantation and better implant primary stability. The compression kit can be operated either manually or with a contra angle, according to the surgeon`s choice.
T.B.R Group has introduced a unique ziconium collared implant. It features one-stage titanium implant with a zirconium trans-gingival emergence collar. They claim that the Zirconia enhances the fibroblast and osteoblast cell adhesion and proliferation compared to titanium, provides for lower bacterial colonization at the collar and shows evidence of creeping attachment of the gingiva to the zirconium collar.
Tactile Tech has introduced the Implant Location System (ILS) which applies tactile sensing technology to offer intra-oral image-guided navigation specifically for dental practitioners. It is a computer-guided sensing, navigation and guiding suite for placement of dental implants designed both for the general practitioner and the expert. It provides safety and restorative accuracy without introducing the great complexity of other navigation systems.