SDS Swiss Dental Solutions AG • Zollstrasse 8 • CH-8280 Kreuzlingen • Fon +41 71 6712404; Fax +41 71 6712405

www.swissdentalsolutions.com • info@swissdentalsolutions.com

PRODUCTINFORMATION SDS1.0 ATZ

1. Material 2. Bone Classes 3. Implants and Parameters 4. Stability 5. Drilling Sequences 6. Instructional Films

1. Material In principle, SDS1.0 one-piece implants are produced from SDS ATZ:

SDS1.0 ATZ >> a high-tech implant with an exceptionally safe and quick ZircaPore® surface which demonstrates its advantages in particular in highly stressed and difficult situations such as with immediate implants, sinus lifts and in central chewing areas associated with above-average crown length.

The new ATZ (aluminium-toughened zirconia) makes the SDS1.0 implant almost twice as stable as conventional zirconia.

As compared with aluminium-oxide ceramics (Al2O3) with a bending strength of roughly 500 MPa (megapascal) and standard TZP zirconia (ca. 1.200 MPa), the material of which most ceramic implants are produced today, SDS ATZ demonstrates excellent stability at 2.000 MPa and is therefore recommended for all high mechanical stress situations.

The ATZ surface is applied additively onto the implant using a complex process (slurry process), though it consists of 100% TZP, because ATZ does not osseointegrate as well as TZP.

This surface is not a coating and instead constitutes a thoroughly solid bond with the core (analogous to a number of firings in the production of ceramic crowns).

No other materials or procedures are currently capable of producing a rougher surface with undercutting lacunae, because in contrast with almost all other processes (including those relating to titanium surfaces) this does not involve an erosive process and instead employs an additive process.

SDS1.0 ATZ-implants provided with ZircaPore® surface can be treated with crowns starting at 6 weeks in both upper and lower jaws at an intraoperatively torque of > 45 Ncm and higher.

In many cases, immediate loading may even be possible. Especially for use where splinting of 3 or more stable implants is involved.

2. Bone Classes

No craftsman or boat-builder would ever think of using the same kind of screw in such distinctly different materials as steel, hardwood and balsa wood. But that is exactly what has been happening in dental implantology for over 50 years. SDS Swiss Dental Solutions AG is the first implant manufacturer ever to offer a selection of implants perfectly customized for absolutely identical systems in the prosthetic area and for identical drilling protocols up to the countersink (in other words, up to the 3rd drill) and for all bone classes. Implantology aims to achieve the same degree of primary stability (of more than 35 Ncm) in extremely soft bone (class IV), which may be as soft as butter where it consists purely of cancellous bone with large compartments, as it does in extremely hard bone (class I), which can be as hard as stone when it consists of pure cortical bone (compacta). After using the first three drills – round bur, pilot drill and countersink – the implantologist can decide which design will achieve optimum primary stability in the bone at hand.

Implant Designs RD (Root Design): while it may at first glance look like a root-analog conical implant, it is actually a parallel-walled, cylindrical implant. The advantage of cylindrical implants is that the force remains the same while screwing in and out. Uncontrolled stress spikes occur with conical implants while screwing in – and the implant loses stability uncontrollably when rotated in reverse. The RD implant possesses a bone-condensing component by virtue of its pointed tip and is employed in particular in bone classes II-III, primarily in the upper and lower premolar and frontal areas. And it is clearly the preferred type for all immediate implants, since in this case drilling is not generally congruent to the alveolus. The root, and therefore the alveolus, is practically always localized to the vestibular and seldom in the mid-alveolar ridge. Drilling should, however, always take place precisely in the mid-alveolar ridge so that the implant is sufficiently encircled by bone. For other systems, this results in the problem of having to cut threads at an angle -- for all practical purposes an impossible undertaking. With the RD, however, the slim, round tip bites instantly into the drilled hole and guides the implant into the position intended. With each turn the threading anchors the implant, providing for a secure and reliable insertion into the designated cavity. The tulip seals the alveolus while simultaneously supporting the surrounding hard and soft tissues. Soft bone of classes III and IV generally has the advantage (better than class I) of being well supplied with blood, but is unfortunately soft and low in density. In such situations it makes no sense to drill out the bone and create a congruent drill cavity. It has also been established that, similar to thread cutting in condensing bone using a bone condenser, the implant is never able to seat itself properly in the cut or condensed thread and bone cells are damaged unnecessarily in the process. DT (Dynamic Thread™): this implant possesses a new type of threading (patent pending). This dynamic threading integrates a bone condenser and is somewhat comparable to a Spax screw. The triangular, conical tip is encircled by a parabolic thread, which means that the greatest thread depth is in the area of greatest bone condensation, which serves to prevent stripping (“perpetual threading“). This allows the implant to easily achieve a primary stability of 45 Ncm and more in bone of classes III and IV, which reduces healing time to 6 weeks. Depending on the situation, the implantologist can decide whether he wishes to follow standard protocols (see section 5: drilling sequences) up to the form drill or whether to go ahead and insert the implant following the pilot drill. In extreme cases, it is even possible to insert the implant directly after the round bur without first drilling out any bone. The drilling sequences (see below) show that, given proper processing, the implant may also be used in bone classes II and I.

3. Implants and Parameters

The calibration of implant length with respect to drill, bone and gingiva:

drill settings are 8–11–14 mm, with an additional 3 mm to the end of the drill (17 mm)

the implant’s standard bone margin is located above the end of the thread – this correlates with the implant length specifications (8-11-14 mm)

there are further 3 mm from that point to the crown margin, so that the next higher drill marking (or the end of a drill set to 14 mm) always indicates this margin

implants can be inserted up to 1.5 mm deeper, meaning 8-9.5 mm, 11-12.5 mm, 14-15.5 mm. This maintains a biological width of 1.5 mm to the crown margin. This limit is indicated by the countersink laser marking

the upper margin of the countersink corresponds precisely with the crown margin and the next highest drill marking, allowing for the precise setting of the crown margin level and thus of the biological width as well. The countersink fits into the pilot drilling with its 2.4 mm pilot pin so that it is no longer necessary to enhance with a core drill in order to make use of the countersink. The length of this pilot pin is less than that of the shortest implant and yet it provides excellent guidance characteristics

since the distance between the bone margin and the gingiva margin is almost always around 3mm, at the standard insertion depth the crown margin is then automatically at the gingiva margin

with immediate placement this circumstance can be used to fullest advantage by drilling to + 3 mm of the intended length at gingiva level (and if the proposed length is 14 mm, simply bore up to the end of the drill, since this ends a further 3 mm above the 14 mm mark). The countersink can then also be sunk to gingiva level. The implant will now be seated exactly with crown margin at the gingival level

4. Stability This is clearly one of the most important topics for users of zirconia implants. After using them for 12 years, it’s obvious to us that zirconia is outstanding in terms of osseointegration and demonstrates superior soft-tissue performance. Users and potential users are particularly pleased with the degree of stability it provides. Several overall qualities of the ceramic materials were discussed in Section 1. Here we would like to consider design characteristics. SDS Swiss Dental Solutions AG has its own testing equipment (which accords with the requirements as per ISO 14801) and has examined and fractured hundreds of implants, both of its own manufacture and those made by its competitors. ISO 14801 indicates that implants be embedded with a simulated bone resorption of 3 mm, that crown length be 14 mm and the load direction 30°. This simulates a perfect worst-case scenario. This distinguishes between dynamic stress and static stress. During dynamic stress 5 million cycles are measured at a defined force (dry, 15 Hz) -- which corresponds to approximately 20 years. The manufacturer Etkon, for example, reports continuous load stability for its framework materials of 120 N (Newton) over 5 million cycles. 120 N of force are also applied to implant abutment interfaces – and even at 1 million cycles not all the abutments from other companies survive. (Steinebrunner, Wolfhart, Ludwig, Kern: Implant-abutments interface design affects fatigue and fracture strength of implants).

The fracture strength of competing manufactures (diameter approx. 4.0 mm) lie in roughly the same range as the TZP implants from SDS. SDS1.0 ATZ implants are, however, altogether within the same range as titanium implants (values taken from a study by Heraeus). The ATZ implant RD 5.4 mm could not be fractured – the testing equipment shut down at 1.500 N:

5. Drilling Sequences We recommend that you print out the following drilling sequences and keep a laminated copy on hand during surgery for reference. On the one hand, this ensures that procedures are strictly adhered to. On the other, it provides for variations subject to given bone density and allows the preparation of the implant bed to be optimally customized to fit any non-standard situation that may arise. The illustrations show the respective drilling sequences, from the round bur to the form drill, projected onto the implant so that you can see exactly what thread depth remains for proper stabilization. The red box at the bottom of the illustration shows the type of implant and its use with respect to a variety of bone densities. All SDS drills can be used with drill-stops for precise depth control. They include laser designations by type and diameter, as well as color-coding so that you can easily follow the drilling sequences.

SDS1.0 Root Design Implants

SDS1.0 ATZ Dynamic Thread™ Implants

Used in combination with the RD3.00, the DT38 may also be used in class II bone, since the lower segment of the form drill RD is broader, requiring less bone condensation.

In extreme cases, the DT38 may also be used in class I bone. A special drill, the C3.5, is available for the purpose and will leave a thread of 0.15 mm on both sides.

A special drill is also available for the DT46, for use in class I bone (C4.3).

6. Instructional Films There are currently 9 instructional films available for live streaming showing a variety of situations with various types of implants. We specifically developed a new camera technique offering large pictures during surgery that give the observer a better perspective on the OP-area than the operating surgeon has himself! Text comments are included in the films. Large images of the drills, tools and implants used appear on the screen to help you systematically recall the drilling sequences employed. You also have the opportunity to download these films for repeat viewings on your smartphone or tablet.

If you wish, you can then view the planned situation on a digital device prior to or during the surgery. In the coming weeks, additional films will be prepared dealing with every sort of potential situation, which you can use to supplement your own know-how. These will also include surgeries not directly connected with zirconia implants – such as a quick and simple procedure for successful sinus lift surgery. Please contact me directly with any specific requests you may have with regard to films, surgeries or treatments: uv@zahnklinik.de .

Kreuzlingen 15. January 2016