Nobel Biocare has announced the worldwide launch of its new, innovative implant, NobelActive.
Designed together and tested by experienced clinicians, NobelActive will expand the possibility for implant treatment therapy to more dental patients. With its unique tip and double-variable thread design, NobelActive condenses bone during insertion unlike conventional self-tapping implants.
This bone-condensing capability delivers high initial implant stability, even in compromised bone situations, and can eliminate the need for time-consuming and unpleasant implant procedures for patients, such as bone-grafting.
The bone-condensing property and apical drilling blades also allow the experienced user to "actively" change direction during insertion to gain optimal orientation of the prosthetic connection, thereby facilitating the esthetic restoration process.
The unique dual-function conical prosthetic connection, with hexagonal interlocking, supports a wide range of prosthetic options, including individually designed Procera abutments and Procera Implant Bridges Zirconia and Titanium.
As with all Nobel Biocare products and solutions, NobelActive has undergone intensive mechanical and clinical testing:
* Mechanical testing has validated that NobelActive possesses the strength to withstand the rigors of occlusal loads.
* Nobel Biocare is currently running three consecutive prospective multi-center studies involving 19 centers, more than 300 patients, and more than 300 NobelActive implants. One-year results support the effectiveness of NobelActive.
* Prior to this launch, Nobel Biocare subjected NobelActive to an eight-month, intensive worldwide pre-launch with 2,000 experienced clinicians, with positive response from doctors involved.
"NobelActive is the first implant being introduced following new, more rigorous scientific standards," said Domenico Scala, CEO of Nobel Biocare. "The product comes with a one-year clinical study and an extended phase during which the implant was validated by experienced clinicians worldwide. We are also committed to long-term follow-up studies for this product, underpinning our ambition to be synonymous for scientific leadership. This product has the potential of significantly expanding treatment possibilities and providing both dental professionals and patients with new less invasive treatment options."
Designed with clinicians' needs in mind
The tapered implant design of NobelActive has been developed to satisfy surgical and restorative clinicians' requirements. Clinicians demand implant systems with maximum flexibility, both for placement and restorability. Depending on the application, surgeons want the option to place implants in two-stage, one-stage, and immediate loading procedures, all of which should be possible with a minimum amount of preparation in all qualities of bone.
With respect to restoration, clinicians require implant solutions that offer a variety of prosthetic options such as titanium and zirconia standard and custom abutments, screw-retained restorations, and abutment-level restorations in short-span or full-arch bridges in titanium and zirconia.
The NobelActive design has been balanced to ensure long-term service of the implant and the restoration for the patient.
NobelActive designed and proven for treatment flexibility
Double variable thread body: The body design of NobelActive offers high initial stability, a bone-condensing property, and redirecting capability for optimal placement flexibility.
The expanding tapered body with double variable thread design of NobelActive was designed for quicker insertion, narrow ridge expansion, and gradual bone condensing. These design features in turn produce high initial implant stability, even in compromised bone situations, offering.
Experienced surgeons are able to "actively" change the direction of NobelActive during insertion. This enables repositioning at different angles with exceptional initial stability and optimizes the final orientation of the prosthetic connection for ease in the esthetic restoration phase of treatment.
Dual-function prosthetic connection: The dual-function prosthetic connection of NobelActive was designed for compact size, high strength, and prosthetic flexibility.
The internal conical connection with hexagonal interlocking provides secure repositioning of single abutments and creates a sealed connection.
In its second function, the horizontal surface serves as a platform for implant-level Procera Implant Bridges Titanium and Zirconia. This eliminates the use of abutments with these restorations and provides a cost savings to the patient.
Built-in Platform Shifting: The flat surface surrounding the conical connection yields a 1/4-mm wide built-in Platform Shifting around abutments. Platform Shifting increases the volume onto which alveolar soft tissue can grow, which can lead to enhanced Soft Tissue Integration and more natural-looking esthetics.
TiUnite: NobelActive comes with TiUnite, the highly crystalline and phosphate-enriched titanium oxide surface, which is unique to Nobel Biocare. TiUnite is a patented Nobel Biocare biomaterial that has been documented to enhance osseointegration and increase the predictability of implant treatment, both in the short and long-term.
Since its introduction in 2000, the TiUnite surface has been in clinical use and has shown it provides better stability during the healing phase than implants with machined surfaces. This evidence has provided the basis for the treatment modality of Immediate Function.
Groovy: Grooves have also been added to NobelActive. The unique arrangement of macroscopic surface grooves, or Groovy, is a feature that Nobel Biocare developed to work in conjunction with the TiUnite surface. Testing has demonstrated that surface bone forms faster within the grooves, compared to implants without grooves.
Novel NobelActive features
The variable thread profile of NobelActive becomes wider vertically and shorter horizontally. The core of NobelActive forms condensing lines, unlike the linear profile of conventional tapered implants.
Looking up from the bottom, the double threads begin with two drilling blades on the apex, which facilitate insertion into minimally prepared sites.
From the apical region, the double variable threads follow an expanding tapered body, which acts like a threaded osteotome. This enables narrow ridge expansion and is designed to provide high initial stability in compromised bone situations.
Running along the implant body are two reverse-cutting flutes (length of the flutes depends on implant length). Turning NobelActive counterclockwise (1/2 turn) engages the cutting capability of these flutes, this gradually widens the osteotomy and allows for the continuation of implant insertion.
The coronal region is back tapered in all but the narrowest of implant diameters and is designed to maximize alveolar bone volume around the implant and improve soft tissue support.
Well-documented mechanical strength and scientific results
Nobel Biocare is committed to researching, testing, and documenting its products and solutions for safety and efficacy, before and after launching. This commitment is evidenced by a minimum of one-year clinical follow-up data and documented results from mechanical testing, pre-launch activities, and clinical studies.
Mechanical testing
To ensure products have the strength to endure occlusal loads found in the mouth, Nobel Biocare performs extensive mechanical testing.
NobelActive has been both tested for fatigue (endurance) and torque strength. Fatigue strength is the maximum loading that an implant/abutment combination can sustain for a minimum of five million cycles (ref. ISO 14801). The maximum loads at 5 million cycles are:
* NobelActive Ø3.5 and Ø4.3, with titanium abutment: 222 N and 355 N, respectively
* NobelActive Ø3.5 and Ø4.3, with zirconia abutment: 178 N and 225N, respectively
Having been on the market for many years, Nobel Biocare used the original Brånemark System Ø3.75 ASTM Grade 1 titanium implant with standard titanium abutment to internally benchmark implant strength in 1992. The endurance strength for this implant/abutment combination is 185 N.
Nobel Biocare also measured the maximum torque strength that NobelActive could sustain. These measurements were taken to ensure that the prescribed maximum 70 Ncm insertion torque for NobelActive provided a large margin of safety for the patient. The maximum torque for NobelActive Ø3.5 and Ø4.3 were 282 and 452, respectively.
To complete the testing regimen, the dual-function prosthetic connection was subjected to electron microscopy cross-sectional examination. The specified tolerances for NobelActive and abutments are such that a tight fit is achieved at the top of the connection.
Clinical studies
Nobel Biocare is currently coordinating three prospective multi-center studies to gather information on success rates, bone levels, and soft tissue health and maintenance properties of NobelActive.
The first of the three studies is a five-year randomized controlled prospective multi-center clinical study which was begun April 2006 and the last patient was included May 2007.
The study involves 12 centers in Europe, 177 patients, 199 NobelActive implants, and 126 NobelReplace Tapered implants (as control).
All implants in the study were placed in healed sites and subjected to Immediate Function. The study shows good survival data for NobelActive with a cumulative survival rate of 96.5%. This survival rate is well within the expected range for a multi-center study on implants placed in Immediate Function.
One-year results also show good crestal bone preservation with bone levels and bone resorption comparable to the NobelReplace control group. Stable soft tissue conditions were also recorded during the first year in function.
Overall, the study shows that NobelActive performs well under demanding clinical situations such as Immediate Function, as well as in a wide variety of indications, from single tooth to full arch, in all positions, and in all bone qualities.
The two, 3-year prospective multi-center studies are ongoing. These will record the success of immediately placing NobelActive in extraction sites and into Immediate Function:
* 7 centers in the US, 68 patients, and 79 implants; patient inclusion began February 2007 and ended October 2007
* 6 centers in the US and 60 patients; patient inclusion began November 2007 and is ongoing
Additionally, before being purchased by Nobel Biocare, AlphaBioTEC conducted a retrospective multi-center study on their SPIRAL implant, which is the design platform for NobelActive. Their study included 648 implants in 251 patients, with up to four years follow-up.
The clinical data demonstrates a cumulative survival rate of 98.3%. AlphaBioTEC presented their results at the Nobel Biocare World Conference in Las Vegas (May 2007) and at the European Association of Osseointegration (EAO) in Barcelona (October 2007).
Pre-launch activities
Before making the decision to launch NobelActive, Nobel Biocare performed a worldwide, eight-month pre-launch with leading clinicians. The pre-launch was instrumental in assessing the acceptance and applicability of NobelActive in real-world clinical situations. Additionally, the pre-launch was used to refine and validate the protocols developed for using NobelActive in all surgical situations.
"My experience with this implant confirms that its unique design gives excellent initial stability, which is highly desirable in both immediate placement and lesser bone quality situations," stated Dr. David Dunn, a clinician involved in NobelActive pre-launch activities.
In the course of the pre-launch nearly 200 instructors were educated on NobelActive, who then instructed more than 2,000 clinicians in the use of NobelActive. During the eight months, more than 30,000 implants were ordered and used by pre-launch clinicians. Clinician feedback was gathered through questionnaires, and their input was used to refine the surgical protocols.
Dr. Ken Parrish, another clinician involved in the pre-launch found that, "the unique design of the NobelActive implant allows me to offer my patients what they want. The thread and taper provide great primary stability so I can immediately load everything from single teeth to full arches."
Conclusion/summary
A review of the features and benefits is provided below:
* bone-condensing property delivers high initial stability, even in compromised bone situations
* redirecting capability allows for optimal placement of implant, which results in optimal prosthetic connection orientation
* built-in Platform Shifting designed for better Soft Tissue Integration
* dual-function prosthetic connection works with a variety of prosthetic alternatives
NobelActive comes with solid clinical validation as well as strong acceptance from clinicians that have already experienced using the implant in real-world situations. Clinicians, who have already added NobelActive into their daily routines, praise NobelActive for the ease of achieving the results they want from their implant therapies.
Nobel Biocare strongly recommends those clinicians interested in integrating NobelActive into their practice enroll in a NobelActive training course.
References and figures available from the company.
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