Siscon brochure

swiss star dental implants

Introduction� swiss implant dentistry – a tradition of innovation� siscon medical – a breath of fresh swiss air…� system / products overview

CONTENTS

INTRODUCTION

- swiss implant dentistry - a tradition of innovation- siscon medical - a breath of fresh swiss air…- system / products overview

CASE PLANNING

- general / relative contraindications- templates, x-ray reference sphere

RISK ASSESSMENT

- general and aesthetic risk factors

BASIC SURGICAL PRINCIPLES

- basics and recommendations- flapless surgery- postextraction sites / immediate implant placement

STANDARD DRILLING SEQUENCE / SURGICAL INSTRUMENTS

- overview of drill characteristics- standard sequencing of implant site preparation- countersinking for the Ø3.3 mm implant- tapping related to bone quality- mucosa punch, drill extension, bone shaper- surgical tray

IMPLANT CHARACTERISTICS

- material, production, design, platform- implant-abutment connection, dynamic tests, abutment screw- performance of rough implant surfaces- sandblasted, medium-grit, (thermally) acid-etched (S.M.A.)- packaging and labelling

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CONTENTS

HANDLING OF IMPLANT PACKAGING, INSERTION PROCEDURE

- step-by-step procedure

IMPLANTS

- types, indications and specific contraindications- drill sequences according to implant diameter

PROSTHODONTIC CONCEPT

- considerations on cement-retained restorations, cementation technique- considerations on attachment-retained overdentures, overview of options

TRANSFER & IMPRESSION TAKING

- implant-level, open-tray, screw-retained- implant-level, closed-tray, screw-retained

CEMENT-RETAINED RESTORATIONS

- prefabricated abutments, with / without shoulder (standard / aesthetic)- custom-made abutments, cast-on / burn-out techniques

HEALING & LOADING PROTOCOLS

- healing / loading recommendations- use of cover screw and healing caps

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CONTENTS

ABUTMENTR-ETAINED OVERDENTURES

- single spherical attachments (Dalbo ® PLUS, SPHERA)- splinted implants with SFI-bar ® concept

MATERIAL SPECIFICATIONS

TORQUE GUIDE

QUALITY MANAGEMENT & REGULATORY COMPLIANCE

CARE & MAINTENANCE OF INSTRUMENTS

IMPLANT MAINTENANCE

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CONTENTS

LITERATURE REFERENCES

TERMS & CONDITIONS

SYMBOLS, PRODUCT DECLARATION

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swiss implant dentistry – driven by innovation

High quality is often the watchword for the success of Swiss goods and services around the globe. Working in niche markets, Swiss companies are frequently technology leaders and have established the “Made in Switzerland“ label around the world, leading to positive contacts with Switzerland abroad and laying the groundwork for lasting relations with our country. The Swiss are friendly and hospitable people, though somewhat reserved at times. They are pragmatic, innovative thinkers while they share an independent spirit, a respect for integrity and personal freedom.

If Switzerland had a motto, it might be something like “precision is our tradition,” and the accompanying crest would bear a rendering of a timepiece with grandes complications. A luxury watch represents more than 300 precision parts and many hours of meticulous craftsmanship. The expertise required to manufacture minute parts to precise tolerances transfers remarkably well to the manufacture of medical devices.

In the early 1960’s, P.-I. Brånemark and co-workers at the University of Göteborg started developing a dental implant concept that for clinical function depended on direct bone anchorage – termed osseointegration. Even though Brånemark’s team was the first to suggest a direct bone anchorage (1969, 1977), the scientific community remained unconvinced of the potential of this concept.

The first investigator to clearly demonstrate osseointegration was A. Schroeder from Switzerland. He worked from the mid 1970’s, quite independently from Brånemark, with research on direct bone anchored implants. Schroeder’s team used newly developed techniques to cut through undecalcified bone and implant without previous separation of the anchorage. In, for their time, excellent illustrations, a direct bone-to-implant contact was proved beyond any doubt (Schroeder et al, 1976, 1978, 1981).

The institutionalized, strong symbiosis between science, clinic and industry has a long tradition in Switzerland (e.g. AO, ITI, IBRA, etc.). The success of bringing clinical needs and technological innovation together must therefore be considered the historical and current background to the competitiveness of medical technology coming from Switzerland.

swiss made

development of osseointegrated implants

1. Klöpping Y.(2011): Precision, made in Switzerland. European Medical Device Technology;2,5.2. Albrektsson T.(1997): Osseointegration: Historic background and current concepts. In: Lindhe J. Karring T. Lang N.P. (Ed.):Clinical periodontology and implant dentistry. Copenhagen, Munksgaard.3. Schroeder A., Pohler O., Sutter F. (1976): Gewebsreaktion auf ein Titan-Hohlzylinderimplantat mit Titan-Spritzschichtoberfläche.Schweiz Monatsschr f Zahnheilkunde; 86: 713-727.4. Schroeder A., Zypen E., Stich H., Sutter F. (1981): The reactions of bone, connective tissue and epithelium to endosteal implantswith titanium-sprayed surfaces. Journal of Maxillofac Surg; 9: 15-25.5. Schlich T.(2002): Surgery, Science and Industry. New York: Palgrave Macmillian.

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In the past 25 years, the use of osseointegrated implants have become the standard of care for the rehabilitation of fully and partially edentulous patients, leading to a rapid expansion of implant therapy in dental offices around the globe. Prospective clinical studies have demonstrated survival and success rates clearly exceeding 90% after up to 10 years of follow-up.

Several factors and trends have influenced this development such as greater acceptance among patients and dentists, progress in bone-augmentation procedures and last but not least, the simplification of implant therapy by the development of precise, prefabricated systems. The watch and precision-engineering industries provided the ideal breeding ground for Switzerland to become a centre of excellence in dental and medical technology development and production.

This effort was largely driven and shaped by visionaries who combined the determination to innovate with extraordinary craftsmanship. Its important promoters also included open-minded researchers and clinicians who were receptive to the technical aspects of modern dentistry.

6. Proceedings of the Third ITI Consensus Conference. (2004) Int J Oral Maxillofac Implants;19 Suppl 1-158. 7. Dümmler P, Hofrichter B. (2011): The Swiss Medical Technology Industry Report. Berne: MedTech Switzerland.

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swiss quality, authenticity and innovation

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Although founded in 2011, siscon was really born back in the late 1980’s. That was when the founders got involved with oral Implantology. Everything that was seen, learned and experienced over all those years has now been put together into the swiss star dental implant system. Siscon’s aim is to be the partner of choice in economic and safe implant-borne dental rehabilitations in order to offer dental professionals a lasting difference to the well-being of their patients empowering them to live a healthier and happier life.

siscon medical – a breath of fresh swiss air

25 years ago

siscon (derived from swiss implants concepts) develops, engineers and produces its swiss star dental implant system in close partnership with experienced clinicians, specialized suppliers and premium-quality manufacturers in Switzerland. Prime material and production quality, solid and reliable engineering and predictable clinical outcome combined with outstanding services and competent employees are the key ingredient for success.

Just like most modern dental implant systems, the swiss star concept has all the proven characteristics needed in daily practice. The design, the surface, the sizes, the mechanical and biological features, the materials used and the treatment procedures - every central aspect of the swiss star dental implant system incorporates the best generic features available today. Each of them comes along with comprehensive clinical documentation. But unlike most other systems, it is more compact and focused, resulting in less parts, shorter learning-curves and solid clinical results.

background and assignment of siscon medical

siscon’s assignment is to provide economically attractive, premium-quality dental technology to restore edentulous and partially patients with implant-borne restorations. Innovation requires finding the limits of existing solutions, to explore new paths breaking free from standards and paradigms. Unique handling, meticulous precision, excellent finishing and strict focus on user’s benefits are the main forces behind siscon.

This is being done in permanent and close cooperation with users, research centres, technology providers and other stakeholders driven by two main factors: long-term improvement of patient’s quality of life and our unconditional passion for oral Implantology reflected in every single product.

values make the difference

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8. van der Wijk P., Bouma J., van Waas M.A.J., van Oort R. P.,Rutten F.F.H.(2008): The cost of dental implants as compared to conventional therapies. International Journal of Oral & Maxillofacial Implants; 13(4): 546 – 553.

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SWISS STAR DENTAL implants

ArticleImplant Ø 3.3, L 7, p Ø 3.8Implant Ø 3.3, L 9, p Ø 3.8Implant Ø 3.3, L 11, p Ø 3.8Implant Ø 3.3, L 13, p Ø 3.8Implant Ø 3.3, L 15, p Ø 3.8Implant Ø 3.8, L 7, p Ø 3.8Implant Ø 3.8, L 9, p Ø 3.8Implant Ø 3.8, L 11, p Ø 3.8Implant Ø 3.8, L 13, p Ø 3.8Implant Ø 3.8, L 15, p Ø 3.8Implant Ø 4.3, L 7, p Ø 3.8Implant Ø 4.3, L 9, p Ø 3.8Implant Ø 4.3, L 11, p Ø 3.8Implant Ø 4.3, L 13, p Ø 3.8Implant Ø 4.3, L 15, p Ø 3.8

Ref. Nr.15-38-33-0715-38-33-0915-38-33-1115-38-33-1315-38-33-1515-38-38-0715-38-38-0915-38-38-1115-38-38-1315-38-38-1515-38-43-0715-38-43-0915-38-43-1115-38-43-1315-38-43-15

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surgical trays

ArticleSurgical Tray, Type 1Surgical Tray, Type 2

Ref. Nr.46-085-5046-148-50

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healing phase

ArticleCover Screw (incl. in all implants)Healing Cap S, p3.8, H 3Healing Cap S, p3.8, H 5Healing Cap S, p3.8, H 7Healing Cap A, p3.8 H 3Healing Cap A, p3.8 H 5Healing Cap A, p3.8 H 7

Ref. Nr.16-38-32-01 17-38-41-0317-38-45-0517-38-45-0717-38-55-0317-38-55-0517-38-55-07

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transfer, master cast production

ArticleImpression Coping OTS, p3.8Impression Coping OTA, p3.8Screw for Impression Coping, OTImpression Coping CTS, p3.8Impression Coping CTA, p3.8Impression Coping, 25°, CTS, p3.8Screw for Impression Coping, CTImplant Analog, p3.8

Ref. Nr.21-38-42-1121-38-52-1122-38-18-2022-38-42-1122-38-52-1122-38-42-1222-38-18-1522-38-00-00

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miscellaneous

ArticleDALBO / SPHERAInsertion Tool, ISOScrewdriver, manual, shortScrewdriver, manual, longHandle with ISO latch,extra-long

Ref. Nr.45-28-24

41-26-0841-26-1541-26-105

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surgical instruments

ArticleRound Bur Ø 1.8Pilot Drill Ø 1.5Guide Drill Ø 2.3, mediumParalleling PinDepth GaugeCountersink Drill Ø 3.8 Final Drill Ø 2.8, mediumFinal Drill Ø 3.3, mediumFinal Drill Ø 3.8, mediumBone Tap Ø 3.3Bone Tap Ø 3.8Bone Tap Ø 4.3Hex-Driver ISO, shortHex-Driver ISO, mediumHex-Driver ISO, longImplant Insertion Tool ISO, longImplant Insertion Tool ISO, shortHand Adapter for ISODrill Extender, ISOMucosa Punch ISO, Ø 3.5Mucosa Punch ISO, Ø 4.7Torque Wrench Adapter for ISO Torque Wrench, complete

Ref. Nr.11-18-0011-15-1311-23-1542-215-1642-23-2512-38-33-0511-28-1511-33-1511-38-1512-33-1512-38-1512-43-1541-125-0441-125-0841-125-1341-226-2841-226-1943-32-1642-35-2445-35-2845-47-2843-08-0544-89-105

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products / references at a glance

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abutments, attachment-retained overdentures

ArticleDalbo ® PLUS, p3.8, Ø 2.25, H 1Dalbo ® PLUS, p3.8, Ø 2.25, H 3Dalbo ® PLUS, p3.8, Ø 2.25, H 5Dalbo ® PLUS, Abutment AnalogDalbo ® PLUS, Female Part, completeDalbo ® PLUS, Tuning Lamellae SOFTDalbo ® PLUS, Screwdriver, ActivatorSPHERA p3.8, Ø 1.8, H 1SPHERA p3.8, Ø 1.8, H 3SPHERA p3.8, Ø 1.8, H 5Retentive Cap SPHERA, Ø 1.8Female-Housing SPHERA, Ø 1.8 SPHERA, FemaleSPHERA, Aux. SPHERA, Aux.SPHERA, Aux.SPHERA Abutment Analog

Ref. Nr.31-38-225-0131-38-225-03 31-38-225-05 31-38-225-00 055 8900500 0068072 60932-38-180-0132-38-180-0332-38-180-0533-38-18034-38-180----35-38-180-00

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abutments, cement-retained restorations

ArticleStandard-ABUTMENT, p3.8, Ø 4.0, L 9Standard-ABUTMENT, p3.8, Ø 4.5, L 9.5Standard-ABUTMENT, p3.8, Ø 5.0, L 10Aesthetic-ABUTMENT, p3.8, Ø 4.5, L 9.5Aesthetic-ABUTMENT, p3.8, Ø 5.0, L 1015° Aesthetic-ABUTMENT, p3.8, Ø 5.0, H 215° Aesthetic-ABUTMENT, p3.8, Ø 5.0, H 315° Aesthetic-ABUTMENT, p3.8, Ø 5.0, H 415° Aesthetic-ABUTMENT, p3.8, Ø 5.0, H 525° Aesthetic-ABUTMENT, p3.8, Ø 5.0, H 225° Aesthetic-ABUTMENT, p3.8, Ø 5.0, H 325° Aesthetic-ABUTMENT, p3.8, Ø 5.0, H 425° Aesthetic-ABUTMENT, p3.8, Ø 5.0, H 5BURNOUT-Abutment, p3.8, Ø 4.0, L12CASTON-Abutment p3.8, Ø4.0, L12Abutment Fixation Screw, short headAbutment Fixation Screw, long head

Ref. Nr.23-38-40-9023-38-45-9523-38-50-10024-38-45-9524-38-50-10026-38-02-0826-38-03-0826-38-04-0826-38-05-0827-38-02-0827-38-03-0827-38-04-0827-38-05-0828-38-04-1128-38-04-1225-38-2-0025-38-5-00

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products / references at a glance

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swiss star implants are produced from full profiles to their final shape; they are neither cast nor sintered. The reason for using this demanding procedure is that the starting material is totally free of defects, it offers reproducible, constant properties, which are difficult to achieve with other production techniques. The most important stages in implant manufacturing are:

Cold working of the material (pure titanium according to ASTM F 67 / ISO 5832-2).

Extremely high precision, using state-of-the-art technologies in order to guarantee interchangeability of components and a constant, premium quality.

swiss star implants are basically bone-level, solid screw, self-cutting, cylindrical or tapered implants with a reliable “morse-taper”, internal hex abutment connection.

implant characteristics

production / material

The coronal third of the implant is slightly conical. This means that the threads become gradually shallower while there is a smooth transfer to the micro-threads. This design was established to improve stability by employing the often denser crestal bone more effectively into the primary stability concept. Also, the apical portion of the implant is conical in order to simplify the introduction to the implant site and the tip is rounded-off to avoid critical, potential damages of delicate anatomic structures (eg Schneiderian membrane). Self-cutting grooves are incorporated to improve tapping performance while decreasing torque momentum and allow space for bone residual.

Geometrically, the overall endosseous implant design resembles an asymmetric, orthopaedic cortex screw. Since bone tissue is structured in such a way that it can withstand compressions, one thread is almost perpendicular to the bone to create compression, but no shearing forces. The asymmetric thread design of the cortex screw was simply turned upside down, because in internal fixation, screws have to resist tearing forces, whereas a dental implant is mainly loaded under compressions. It should be noticed that taps are slightly smaller than the corresponding screw-type implant profiles thus increasing the primary stability and at the same time, avoiding excessive pressure by the implant thread to the surrounding bone.

implant / thread design considerations

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The standard prosthetic platform diameter with swiss star implants is 3.8mm and finishes with a small, machined bevel. It offers ample flexibility for using different prosthetic platforms and maintains sufficient space for proper soft tissue management. Since this is basically a bone-level design, micro-threads were added in the marginal portion.

This design feature should help to establish and maintain a solid retention between implant / crestal bone while offering ample load distribution of masticatory forces. We expect that marginal bone loss will therefore be highly limited or none at all. There has been some evidence that a suitable neck and surface design leads to maintenance of the crestal bone levels with single tooth implants.

platform / neck design

For the connection between the implant and the abutments a “morse-taper” design was introduced to the system. This remarkable configuration ensures load transfer that is produced during function into the bone and prevents the occurrence of peak stresses. In theory, an implant with a conical interface can resist larger axial and transversal loads than an implant with a flat interface.

It was also shown, that micro-leakage can occur at the implant-abutment interface in osseointegrated implants and may cause malodour and inflammation of peri-implant tissues.

Furthermore the design guides the abutment into a predictable location with a precise fit with the inner portion of the implant. The conical design also provides a tight connection between the implant and the abutment that avoids the establishment of micro-movements and micro-leakage to a large extent.The internal hexagon has a dual-function – to transfer the torque momentum during implant placement and as an indexing system to transfer the position of the implant to the master-cast. Internal index systems have considerable advantages over external index systems in such a way that they allow longer engaging surfaces while reducing the platform height of the implant. This offers more flexibility in designing the emergence profile of the final restoration. The abutment screw is offered in a one-size-fits-all long / short head design to deliver optimum pre-load with a minimum of torque force application.

implant – abutment connection

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9. Norton M.R. (1998): Marginal bone levels at single tooth implants with a conical fixture design. The influence of surface macro- and microstructure. Clinical Oral Implants Research;9(2);91-99.10. Engquist B, Åstrand P., Dahlgren S. (2003): Marginal bone reactions to oral implants. A prospective comparative study of AstraTech and Brånemark system implants. Clinical Oral Implants Research;13 (4):30-37.11. Merz B.R. Hunenbart S. Belser U.C. (2000): Mechanics of the connection between implant and abutment – the ITI morse-taper vs. a butt joint connection. Clinical Oral Implants Research; 8:290-298.12. Binon P.P. (1996): The effect of implant / abutment hexagonal misfit on screw-joint stability. Journal of Prosthodontics,(14); 149-160.13. Hanson S. (2000): Implant-abutment interface: Biomechancial study of flat top vs. conical. Clinical Oral Implants Research;2(1):33-41.14. Gross M. Abramovich I. Weiss E.I. (1999): Microleakage at the abutment-implant interface of osseointegrated implants: a comparative study. International Journal of Oral and Maxillofacial Implants: 14(1);94-100.

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cement-retained restorations

The development of the swiss star dental implant has been accompanied by in-depth dynamic measurements and FEM calculations. This is the set-up used to test long-term stability according to ISO 14801. Note that a 3 mm crestal bone loss was assumed for the Ø 3.8 mm swiss star implant in order to worsen the conditions by increasing the lever-arm for bending. A relatively high load, compared to clinical values, was applied at an angle of 30° to the longitudinal axis. The test set-up loads the abutment with a steady bending moment and was defined in order to test the prosthetic designs. The load is applied for 5-10 cycles at a frequency of 15 Hz sine wave at room temperature of approx. 19°C, thus determining the long-term stability of the entire design.

dynamic tests

In order to examine the distribution of stresses in the system and to be able to compare them to other designs, the implant-abutment connection was simulated by a non-linear, three-dimensional FEM model according to EN ISO 14801:200872. To simulate average masticatory forces in a natural environment, forces between 240N to 400N were applied respectively in lingual, axial and transversal directions. Particular attention was paid to the strength of the implant walls, they must be able to withstand significant torque loads placed during surgical placement as well as heavy occlusal / masticatory forces without the potential of deformation or even worse, a fracture.The colours scale of FEM images indicate the stress levels – with green the lowest and red the highest. During the design process, modifications are made and continuously tested until the ideal stress distribution and hence strength is obtained.

finite element model (FEM) and conclusions

The abutment screw plays a central role for the mechanical, long-term strength and fatigue resistance of the implant – abutment connection. The requirements for such a screw are many such as no loosening, long-term fatigue resistance, overload-protection and safe pick-up and handling ability.The abutment screw utilizes a proven reduced diameter shaft, a common concept in engineering used in designs subject to heavy dynamic loads. An anti-fatigue shaft screw differs from a normal screw in such a way that the shaft is subject to deformation when exposed to tension and acts like a spring. Tightening the abutment screw imparts in calculated amount of tension (= “pre-load”) on the shaft which compresses the abutment onto the implant to generate a stable connection. This also indicates that the precise application of torque force is essential for the proper function of this concept. The results of these multiple calculations led to the present optimized design, which rules out critical concentration of stresses in either the surrounding hard tissues or the inter-mechanical designs.

the screw is the heart

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15. Mericske-Stern R. Assal P. Bürgin W. (1996): Simultaneous force measurements in 3 dimensions on oral endosseous implants in vitro and in vivo. A methodological study. Clinical Oral Implants Research;7: 378-386 & 387-396.16. DIN 250-1: Bolted connections with reduced shank: Survey, range of applications and examples of installations. 1974-09.17. Köhler H., Jende S.(2004): Motorenverschraubung. Wiesbaden, GWV Fachverlag, Lexikon Motorentechnik.

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Endosseous wound healing can be subdivided into stages of hematoma, clot resolution, and osteogenic cell migration that lead to the formation of new bone at the wound site. The recruitment and migration of osteogenic cells into the wound site is termed “osteoconduction”. This same phenomenon occurs with the migration of perivascular cells to the resorbed bone surface during bone remodelling. Traction forces, exerted by these migrating cells on the transitory biological matrix through which they migrate, and the attachment of the latter (clot retention) to an implant surface is a critical determinant in contact osteogenesis. The phenomenon of initial matrix elaboration by the differentiating osteogenic cell population is defined as de novo bone formation and is distinguished from the slower appositional bone growth that follows by differentiated osteoblasts.

In order to increase the bone-to-implant contacts and to decrease healing times, implant surfaces are roughened to meet modern dentistry requirements. The leading surface technologies today are produced by reducing techniques e.g. sand-blasting and acid-etching, most of them clinically documented during the past 10 years.

endosseous wound healing

Together with the surgical technique by the operator, the macro (screw design) and the micro (surface) structures of the implant play a pivotal role in achieving sufficient primary stability and an uneventful healing. The time-to-loading additionally depends on biological and patient-related issues however, with most surfaces healing recommendations are at least 6 weeks in type 1,2 or 3 bone, no differences are made between maxilla or mandible.

Roughened surfaces, throughout all tests, perform better than machined titanium surfaces. The clinical trials demonstrate that, under defined conditions, standard diameter implants of 4.1 mm / length 10 mm with a rough surface can be restored after six weeks of healing with a very high predictability of success, defined by abutment placement at 35 Ncm without counter torque, and with subsequent implant survival rates of greater than 98% five years after restoration. Rough implant surfaces are optimized mechanically and topographically and have become state of the art for dental implants.

performance of rough surfaces

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18. Davies J.E., Hosseini M.M (2000): Histodynamics of endosseous wound healing. In: Bone Engineering. em2, Toronto.19. Buser D. Broggini N. Wieland, Schenk K. Denzer A. J. D. Hoffmann. B. Lussi A. and Steinemann S. G. (2004): Enhanced bone apposition to a chemically modified SLA titanium surface. Journal of Dentistry 83; (7): 529-533.20. Geurs N. Jeffcoat R. McGlumphy E.A. Reddy M. Jeffcoat M. (2004): Influence of implant geometry and surface characteristics on progressive osseointegration. International Journal of Oral Implants 17: 811-815.21. Åstrand P. Engquist B. Anzen B. Bergendal T. Hallman M, Karlsson U. Kvint S. Rundcranz T. (2003): A three year follow-up report of a comparative study of ITI Dental Implants and Brånemark System implants in the treatment of the partially edentulous maxilla. Implant Dent & Relat Res., (6):130 141. 22. Åstrand P. Engquist B. Dahlgren S. Engquist E. Feldmann H. Grondahl K. (2005): Astra Tech and Brånemark System implants: a prospective 5-year comparative study. Impl Dent & Rel Res (7): 17-26. 23. Li D, Ferguson SJ, Beutler T, Cochran D, Sittig C, Hirt HP, Buser D. (2002): Biomechanical comparison of the sandblasted and acid-etched and the machined and acid-etched titanium surface for dental implants. J Biomed Mater Res;60:325–32. 24. Bornstein MM, Lussi A, Schmid B, Belser UC, BuserD. (2003): Early loading of non-submerged titanium implants with a sandblasted and acid-etched (SLA) surface: 3-year results of a prospective study in partially edentulous patients. Int J Oral Maxillofac Implants;18(5):659–666.

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The mechanisms by which rough-surfaced implants have advantages over smoother implant surfaces are not entirely known yet but may be related to the effects of wound healing, cellular function, and the physical properties related to mechanical interlocking of the surface.For the swiss star dental implant system a sand-blasted, medium-grit, thermally acid-etched (S.M.A.) surface modification process has been employed. The performance of the rough SMA surface is superior to smooth surfaces with respect to bone contact levels and removal torques and thus early loading. The most important property of this surface, which is relevant to implant design and use, is its high load-bearing capability. Immediate, early and delayed loading protocols in single tooth, partially or totally edentulous patients can be applied with SMA-surfaced swiss star dental implants. The individual patient benefit however, should always be taken into consideration.

sand-blasted, medium-grit, (thermally) acid-etched surface / S.M.A.

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25. Cochran D L. (2008): A comparison of endosseous dental implant surfaces. J Periodontol (70): 1523-1539.

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implant packaging, labelling and storage

The following is included with the implants: product information (package insert) 3 patient labels, the patient labels should be used for case documentation.

swiss star implants are sterile packaged. The implant container (sterile ampoule) contains the implant and a corresponding cover-screw which holds the implant securely in place. The information identifying the dimensions of the implants is shown on the label.

the screw is the heart

storage

open the protective packaging immediately before implantation. the sterile packaging must be examined for damage before opening. If the sterile packaging (peel bag) is damaged, the sterility of the products contained therein may be compromised.

when removing the implant container and the swiss star implant from the peel bag and the implant container

A specific colour is assigned to each implant diameter of the swiss star implant system.

Accordingly, all implant packages bear a colour-coded label. This simplifies both logistics and handling.

handling of the protective and sterile packaging

colour code, labelling

swiss star implants must be stored in the original protective packaging in a cool (room temperature), dry location protected from direct exposure to sunlight.

Ø 3.3 mm Ø 3.8 mm Ø 4.3 mm

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general / relative contraindications

case planning

Careful treatment planning is absolutely essential in order to ensure that the implant-supported restoration is successful. Implantation is contraindicated under the following conditions:

Where there is a potential risk of a medical complication—for example, osteonecrosis of the jaw in patients taking oral bisphosphonates and patients undergoing radiotherapy—the option of implant therapy should be chosen restrictively, and the patient should be informed specifically, taking into account the current level of uncertainty with regard to the consequences. For patients with a life-threatening systemic disease, implant placement should be postponed until the patient’s medical condition is stabilized and has improved.

Oral contraindications include but are not limited to uncontrolled parafunctional habits (eg bruxism, clenching), insufficient height and/or width of bone, insufficient interarch space, intraoral infection, xerostomia. Implant treatment is not suitable for children and teenagers until epiphyseal closure has been reached.

insufficient bone quantity or poor bone qualityendangering the primary stability of the implant

acute or chronic infections

subacute chronic osteitis of the jaws

impairment of microvascular circulation

poor general health condition

drug abuse (alcohol, tobacco, drugs)

inadequate oral hygiene, lack of motivation, lack of cooperation

systemic disease, titanium allergy

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X = c / Y

Y= ab

Y = magnification factora = diameter of the X-ray reference sphere as measured in the X-ray image (in mm)b = actual diameter of the X-ray reference sphere (5.0 mm)

X = actual bone height (in mm)c = jaw height measured in the X-ray imageY = magnification factor

pre-surgical planning

case planning

Comprehensive pre-surgical diagnostics and planning are always required. This provides information for implant placement and for the design of the superstructure. Good communication between the patient, dentist and dental technician is the basis of thorough case planning. In order to study the anticipated and functional result, a wax-up may be produced on a study cast, indicating the best positions and inclinations for the implants. This is especially recommended when working in the anterior maxilla, where the aesthetic outcome is most obvious. The wax-up can, also be used to show the patient the suggested treatment result, and it may later be used to fabricate a surgical stent.To support thorough case planning, siscon provides X-ray templates for swiss star implants with various magnification scales (distortion factors) assisting the user in determining the optimal implant diameter and length. The magnification or distortion factor can be determined by directly comparing the size of the X-ray reference sphere as it appears in the X-ray image to the various magnifications on the X-ray template for swiss star implants, or by measuring the size of the X-ray reference sphere as it appears in the X-ray image and calculating the magnification using the known actual size of the X-ray reference sphere.After determination of the magnification factor, the interdental spatial relationships can be determined with the scale on the X-ray template or by calculation. The X-ray templates for the swiss star implants, and for the reference sphere, serve only as guidance for determining the most suitable implant size and positioning. In critical areas, further detailed investigations (e.g. by recording a CT) may be required.

X-ray reference sphere Ø 5.0 mm

Knowing the vertical bone height is a prerequisite for selecting the appropriate implant length. For this purpose, an X-ray reference sphere must be incorporated in the radiograph. After the X-ray is made, the magnification factor (i.e. 1.1:1 etc.) can be determined by direct comparison with the reference sphere or the scale on the “X-ray template for swiss star implants” or calculation as noted below.

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“A risk patient is a patient in whom the strict application of the standard protocol does not offer the expected results” (Renouard, 1999). Successful, predictable implant treatment - especially in sites of aesthetic relevance - requires advance detection of specific risk factors that may lead to complications and failure. For some patients, identification of specific risk factors may lead to modification of the treatment plan (eg prolonging healing time, placing more/less implants, reducing prosthetic extensions), while others may contraindicate implant treatment altogether. Some important points to remember from the perspective of risk management are:

1. Carefully evaluate the patient’s medical condition and suitability for implant treatment;

2. Take the necessary precautions to minimize the risk of failure;

3. Identify factors that may hinder success and inform the patient of how they may affect outcome;

4. Obtain informed consent from the patient as part of the treatment record;

5. Acquire and develop the necessary clinical skills in both surgical and prosthetic treatment;

6. Establish a maintenance protocol designed to achieve long-term success.

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X-ray reference sphere Ø 5.0 mm

risk assessment

The available bone can be measured accurately using the scale corresponding to the determined magnification factor or by the following calculation.As part of the planning process, follow the recommended distances between neighbouring teeth and implants. The goal is to achieve an ideal emergence profile, optimal anatomical shape and a suitable restorative position. Appropriate spacing will promote good maintenance and hygiene of the prosthetic reconstruction.For complex cases, more sophisticated planning instruments are available. Computer technology and medical imaging can be used to virtually place anterior and posterior dental implants and to construct a precise surgical template and prosthesis, which is connected at the time of implant placement. This procedure drastically reduces patient office time, surgical treatment time, and the degree of post-treatment recovery.27

27. Balshi F.S., Wolfinger G.J., Balshi T.J. (2006): Surgical planning and prosthesis construction using computed tomography, CAD/CAM technology and the internet for immediate loading of dental implants. Journal of Esthetic and Restorative Dentistry; 18(6), 312-323.28. Renouard F., Rangert B. (1999); Risk factors in implant dentistry. Chicago, Quintessence.29. Cheung W.W.M. (2006): Risk management in implant dentistry. Hong Kong Dental Journal; 2: 58-60.

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mechanical and technical risks

The aesthetic risk profile will help minimize potential restorative pitfalls that may ultimately be associated with unacceptable restorative outcomes. While the restoration itself can be enhanced by the expertise of the dental technician through office-laboratory communications, it is necessary for the restorative dentist to have a clear understanding of the materials and techniques involved in enhancing the soft-tissue response around a restoration.

This table summarizes the various risk factors. The individual risk profile of each patient is established based on a detailed preoperative analysis. The aesthetics protocol by Fradeani (2005) is also highly recommended.

Apart form a comprehensive patient risk assessment; one should also consider mechanical / technical risks. These risks play an important role in implant dentistry as they may lead to increased rates of repairs and remakes, and a waste of time and financial resources. They may even affect the quality of life of the patient. During treatment planning, constellations known to be associated with increased risk should be avoided. In summary, the absence of a metal framework in overdentures, the presence of cantilever extensions > 15mm and of bruxism, the length of the reconstruction, and a history of repeated complications were associated with increased mechanical / technical complications.32

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30. Buser D, Belser U, Wismeijer D (Ed., 2007). ITI Treatment Guide. Berlin, Quintessence.31. Fradeani M (2005); Ästhetische Analyse. Berlin, Quintessenz.32. Salvi G.E., Brägger U.(2009) Mechanical and technical risks in implant therapy. International Journal of Oral and Maxillofacial Implants;24(suppl):69-85.

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AESTHETIC RISKFACTORS

medical status

smoking habit

patient’s aestheticexpectation

lip line

gingival biotype

shape of tooth crowns

infection at implant site

bone level atadjacent teeth

restorative statusof neighbouring teeth

width of edentulous span

soft-tissue anatomy

bone anatomyof alveolar crest

LOW

healthy patient and intact immune system

non-smoker

low

low

low-scalloped, thick

rectangular

none

≤ 5mm to contact point

virgin

1 tooth (≥ 7mm)1 tooth (≤ 5.5mm)

intact soft tissue

without bone deficiency

MEDIUM

light smoker(< 10 cig/d)

medium

medium

medium-scalloped,medium-thick

chronic

5.5 – 6.5mmto contact point

1 tooth (< 7mm)1 tooth (< 5.5mm)

horizontal bone deficiency

HIGH

reduced immune system

heavy smoker(> 10 cig/d)

high

high

high-scalloped,thin

triangular

acute

≥ 7mm to contact point

restored

2 teeth or more

soft-tissue defects

vertical bone deficiency

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basic surgical principles

To achieve successful osseointegration, a precise and low-trauma surgical technique is required. Surgeons must take important measures preoperatively to prevent postsurgical infection, handle surgical instruments expertly to preserve soft tissues, and carefully accomplish adequate implant site preparation without overheating the bone. Precise surgical protocol includes the following precautions:

Preoperative mouthwash with 0.1% chlorhexidine

Perioral skin disinfection with alcohol solution

Antibiotic prophylaxis 2 hours prior to surgery (e.g., 2g amoxicillin intraorally)

Low-speed drilling (between 500 – 600 rpm), avoid excessive pressure

Cooling spray during drilling with chilled sterile saline

Intermittent drilling technique

Use of sharp drills

It is important to perform a surgical procedure systematically, always applying the same surgical principles.

planning and execution

Implant therapy requires comprehensive preoperative planning and precise surgical execution based on a restoration-driven approach.

patient selection

Appropriate patient selection is essential in achieving long-term implant success. Treatment of high-risk patients identified through site analysis and a general risk assessment should be undertaken.

implant selection

Implant type and size should be based on site anatomy and planned restoration. Inappropriate choice of implant dimensions may result in hard / soft tissue complications.

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34basic recommendations

33. Buser D., Cho J. Y., Yeo A. B. K. (2007): Surgical Manual of Implant Dentistry. Chicago, Quintessence.34. Buser D., Belser U., Wismeijer D. (Ed., 2007). ITI Treatment Guide. Berlin, Quintessence.

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flapless surgery

postextraction sites / immediate implant placement

implant positioning Correct three-dimensional implant placement is essential for a successful treatment outcome. Respect of the comfort zones in these dimensions results in an ideal implant position, allowing for an implant restoration with stable, long-term peri-implant tissue support.

soft-tissue stability For long-term aesthetic soft-tissue stability, sufficient horizontal and vertical bone volume is essential. When deficiencies exist, appropriate hard and/or soft-tissue augmentation procedures are required.

Flapless surgery technique should normally be reserved for skilled and experienced implant surgeons who utilize comprehensive three-dimensional planning. A review of the literature indicated, that it is apparent that implant survival using this technique appeared to be efficacious and clinically effective; however, this information was derived from relatively short term studies

Whenever implants are placed in postextraction sites, the need for regenerative therapy must always be assessed. Bone augmentation is recommended to compensate for bone modelling, and to optimize functional and aesthetic outcomes. In all suggested healing protocols the ability to attain primary stability in the appropriate restorative position is a requirement. Presence of an acute infection is an absolute contraindication. Immediate implant placement may be considered in patients and sites with a low aesthetic risk profile. This includes single-tooth sites with thick tissue biotypes and with thick and intact facial bone walls.

35. Palacci P., Ericsson I. (Ed., 2001). Esthetic Implant Dentistry: Soft and Hard Tissue Management. Chicago, Quintessence.36. Hämmerle C.H.F., Stone P., Jung R.E., Kapos T., Brodala N. (2009); Consensus statements and recommended clinical procedures regarding computer-assisted implant surgery. International Journal of Oral and Maxillofacial Implants;24(suppl):126-129.

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