Multilink Implant. Scientific Documentation

Transcription

1 Multilink Implant Scientific Documentation

2 Scientific Documentation Multilink Implant Page 2 of 17 Table of Contents 1. Introduction and Product Description Luting agents and cements Luting composites Curing of adhesive luting composites Multilink Automix and Multilink Implant The proven Multilink Automix Multilink Implant: luting system for implant restorations Using the quarter technique for excess removal Technical Data Materials Science and Physical Investigations Flexural strength Radiopacity Water absorption and water solubility Adhesion to implant abutments Shear bond strength on zirconium oxide (Y-TZP, IPS e.max ZirCAD MO0) Shear bond strength on titanium Shear bond values on different metals and ceramics Bonding of zirconium oxide abutments on titanium bases Clinical Studies with Multilink and Multilink Automix Biocompatibility Data Literature...16

3 Scientific Documentation Multilink Implant Page 3 of Introduction and Product Description 1.1 Luting agents and cements Luting agents are used in dentistry as an adhesive medium to attach fixed prosthetic restorations to the tooth structure. The entire group is often erroneously called "cements". Same as in the construction industry, "cements" are exposed to various environmental conditions in the oral cavity. However, the cements used in the building industry would not be suitable to meet the very special conditions in the oral cavity alone for reasons of hygiene and toxicity. The substrates that have to be luted in dentistry cover a wide range. Dental cements and luting composites have to establish a durable bond between the tooth structure and restorations made of various metals and metal alloys, resins, and different ceramics. Since the advent of the first magnesium chloride cements, these materials have been continuously further developed to produce phosphate cements, glass-ionomer cements, resin-reinforced glass-ionomer cements up to adhesive composite materials. The adhesion and esthetic appearance have reached a very high level in the meantime. With the help of adhesive luting composites, it is now also possible to cement restorations with small retentive surfaces. This is also a further step towards minimally invasive tooth preparation with dentists trying to preserve as much of the healthy tooth structure as possible. To date, the following luting agents are available: - Phosphate cements - Polycarboxylate cements - Glass-ionomer cements - Resin-reinforced glass-ionomer cements - Luting composites Despite their obvious drawbacks regarding solubility and adhesion, phosphate cements were, and still are, very popular. They consist of an aqueous phosphoric acid solution and metal oxides, mainly zinc oxide. The setting reaction is based on an acid-base reaction between the phosphoric acid and the basic oxides. They represent a category of very brittle materials. Up until today, the clinical experiences with phosphate cements stretch over more than a 100 years. Polycarboxylate cements consist of metal oxides and polyacrylic acid. The dry mixture is mostly used as a powder, which is mixed with water for processing. The complicated setting reaction takes place by the reaction of metal oxides with the polyacrylic acid. The comparatively high solubility of the cement is a substantial disadvantage. Glass-ionomer cements also enjoy great popularity. They demonstrate the advantage of being able to release fluoride ions. Setting also takes place with the help of an acid-base reaction. In this case, the polyacrylic acid reacts with a calcium fluoraluminosilicate glass. Clinical experiences with glass-ionomer cements have been gathered for more than 20 years. Besides the above described cement setting reaction, resin-reinforced glass-ionomer cements feature, above all, light-curing organic cross-linking agents. Consequently, polymer networks are formed upon exposure to polymerization light. This group of luting agents includes a number of hybrid cements, whose physical and clinical properties strongly vary depending on the composition of the individual components. Their adhesion to the tooth structure is often weak. Luting composites are completely based on dental restorative composite technology. They consist of monomers and inorganic filler particles. Their setting is based on a cross-linking of the polymer chains, which is initiated chemically or by light. Composites are more wear resistant, demonstrate resistance to the oral environment, and offer outstanding esthetics provided by the choice of several shades.

4 Scientific Documentation Multilink Implant Page 4 of 17 Phosphate cements, polycarboxylate cements, and glass-ionomer cements belong to the group of "dental water-based cements", whose properties are specified by ISO Composite "cements" are covered by ISO 4049, which also applies to the entire range of composite restorative materials. Using the example of compressive strength, the properties of the different types of luting agents are compared with each other. Compressive strength of different types of luting agents Compressive strength / MPa Zinc phosphate Polycarboxylate Glass ionomer RR glass ionomer Composite Fig.1: Average values from different sources in the literature (RR glass ionomer = resinreinforced glass-ionomer cement = hybrid cement). 1.2 Luting composites Luting composites are used in combination with a dental adhesive system. This means that this type of cementation establishes an adhesive bond with the tooth structure. Adhesive cementation also permits a bond, where no large retentive surfaces were or could be prepared. An adhesive bond increases the fracture resistance and thus the survival rate of restorations fabricated of non-high-strength ceramics. Minimally invasive restorative techniques, such as adhesive bridges, would be unthinkable without adhesive luting composites. Etching removes the smear layer and demineralizes the outer dentin layer. After curing, the bonding agent forms an interpenetrating network with the exposed collagen fibres, which is known as the hybrid layer. In order for the collagen fibres to be available for this network, the tooth must not be overdried. 1.3 Curing of adhesive luting composites Most adhesive luting cements are light- and / or dual-curing. In other words, the curing light must (light-curing) or should (dual-curing) reach the composite unimpeded to achieve quick and thorough polymerization. However, restorations made of metals, metal alloys, and opaque ceramics, e.g. zirconium oxide, are impervious to light. To date, such restorations were usually incorporated using conventional phosphate cements and glass ionomer cements. These cements, however, require well-prepared retention to establish a durable bond, which, very often, entails a substantial loss of tooth structure.

5 Scientific Documentation Multilink Implant Page 5 of Multilink Automix and Multilink Implant The proven Multilink Automix The luting system Multilink Automix consists of a composite and Multilink Primer A and B. The corresponding initiator system permits a chemically initiated polymerization (self-curing), which is accelerated by the contact of the composite with the primer. Furthermore, the presence of a photoinitiator also enables final polymerization with light. Multilink Automix is a composite and is used in conjunction with Multilink Primer. Multilink Primer is a self-etching adhesive system, which is offered in two bottles. One contains the acidic monomers and the other the initiator solution. These two components are mixed in a 1:1 ratio and applied on the dentin for 15 seconds and on the enamel for 30 seconds. The indirect restoration can be seated using Multilink Automix immediately afterwards. The high adhesive strength values are reached after a few minutes already. They are also responsible for an excellent marginal seal and the prevention of postoperative sensitivity. A few selected product properties at a glance: - Multilink Automix is a self-curing, self-etching luting composite system, which can be used for nearly all the typical clinical cementation applications ( "multi"-use). Moreover, it also offers the possibility of final light-curing. - As a paste-paste system, Multilink demonstrates a pleasant creamy and stable consistency and is supplied in the convenient double-push syringe with a mixing tip. - In the Multilink / Multilink Primer system, the material sets quickly and reliably and excess cement can be easily removed. - Together with the Multilink Primer, very high bonding values are achieved after only a short time. In investigations on the marginal quality, Multilink Automix also showed outstanding results. - In clinical investigations, Multilink Automix showed none or minimum postoperative sensitivity. - Multilink Automix demonstrates high mechanical strength values. - Multilink Automix is based on a hybrid filler technology and is comparable to the tried-and-tested Variolink II as far as the paste composition is concerned. - Excess cement can be easily and quickly removed with the recommended quarter technique Multilink Implant: luting system for implant restorations The curing and working times of Multilink Automix are adjusted in such a way that the selfcuring reaction accelerates upon contact with Multilink Primer. Applying a dentin primer does not make sense if restorations are cemented onto artificial abutments (implant abutments), which consist mainly of titanium or zirconium dioxide. To achieve the same curing and working time as in the cementation on tooth structure, the initiator concentration of Multilink Implant has just been slightly increased over that of Multilink Automix.

6 Scientific Documentation Multilink Implant Page 6 of 17 Fig.2: Customized zirconium oxide abutment (Anatomic IPS e.max Abutment) Fig.3: Crown made of IPS e.max lithium disilicate, adhesively cemented onto an anatomic IPS e.max abutment using Multilink Implant Monobond Plus bonding agent is applied to achieve an adhesive bond to the implant abutment and to the restoration. Monobond Plus comprises three different active ingredients in an ethanolic solution, enabling the material to create a bond to a variety of different substrates.

7 Scientific Documentation Multilink Implant Page 7 of 17 H 2 C H 3 C OH C C O O R Si OH OH Silane methacrylate H 3 C O H 2 C C C O O R P OH OH Phosphoric acid methacrylate H 3 C H 2 C C C O O R Disulfide methacrylate S S The silane methacrylate group establishes a bond to silicate ceramic materials, the phosphoric acid methacrylate group is responsible for bonding to zirconium oxide, aluminium oxide and base metals and the disulfide methacrylate group creates a bond to gold and precious metals and the corresponding alloys. The abutments and restorations are pretreated and cleaned according to the manufacturer s recommendations and coated with Monobond Plus. After a reaction time of 60 sec, the solvent is dispersed and Multilink Implant is applied to place the restoration. Important: Zirconium oxide surfaces must not be cleaned with phosphoric acid (e.g. Total Etch) prior to cementation. Phosphoric acid undergoes an irreversible reaction with the zirconium oxide surface, similar to phosphoric acid methacrylate. In the process, a zirconium phosphate layer forms and this layer prevents the active ingredient of Monobond Plus to couple with the zirconium oxide substrate and, as a consequence, the primer becomes ineffective. The same applies to base metals and base metal alloys. 1.5 Using the quarter technique for excess removal It is often difficult to find the best time for removing excess composite material. If removed when uncured, the composite may accidentally be rubbed out of the cement joint. If the composite is completely cured, excess material has to be removed with grinding equipment. This is particularly difficult in the proximal region. Moreover, the abutment may become damaged in the process. Multilink Implant excess material can be conveniently removed with what is known as the quarter technique: The cement margins are light-cured for a few seconds from four different directions (mesio-oral, disto-oral, mesio-buccal and disto-buccal). If a light intensity of 650 mw/cm 2 (LOP mode of bluephase) is used, light-curing each quarter surface for 2 to 4 sec is enough for the excess composite to obtain a gel-like consistency so that it can be easily removed with a scaler from all areas, even those that are difficult to reach.

8 Scientific Documentation Multilink Implant Page 8 of 17 Fig. 4: Schematic of the quarter technique: Exposure to light from mesio-oral, disto-oral, mesio-buccal and disto-buccal

9 Scientific Documentation Multilink Implant Page 9 of Technical Data Standard composition (in % by weight) Base Catalyst Dimethacrylates and HEMA Ytterbium trifluoride Mixed oxide; highly dispersed silicon dioxide Barium glass filler, Ba-Al-Fluoro silicate glass Initiators and stabilizers Pigments < Physical properties In compliance with ISO 4049:2000 Polymer-based filling, restorative and luting materials Mixing ratio of base and catalyst (1:1) Self-curing Dual-curing Working time (37 C) min. Setting time min. Film thickness < 50 < 50 µm Water absorption (7 days) < 40 < 40 µg/mm³ Water solubility (7 days) < 7.5 < 7.5 µg/mm³ Radiopacity % Al Additional values: Self-curing Dual-curing Flexural strength 70 ± ± 10 MPa Modulus of 3500 ± ± 400 MPa elasticity Compressive 240 ± ± 20 MPa strength Transparency Transp. and Cat. 12 ± ± 1.5 % MO 1 and Cat. 2 ± ± 0.5 % MO 0 and Cat. 2 ± ± 0.5 % Vickers hardness (HV 0.5/30) ± 30 MPa

10 Scientific Documentation Multilink Implant Page 10 of Materials Science and Physical Investigations The most important physical properties of Multilink Automix and Multilink Implant were tested in the laboratories of the Research Centre at Ivoclar Vivadent AG. 3.1 Flexural strength The flexural strength is the resistance of a test sample against flexural stress at the point of breaking. In addition to the compressive strength and tensile strength, it is a significant parameter describing the mechanical strength of a material. The flexural strength of composites is essentially affected by the chemical composition. Flexural strength of self-curing luting composites Flexural strength / MPa Multilink Implant (self-curing) Multilink Implant (light-curing) Panavia 21 RelyX Unicem Fig. 5 Flexural strength of luting composites after self-curing (Ivoclar Vivadent AG, R&D) The cements were cured for 1 h at 37 C and stored in water for 23 h at 37 C. 3.2 Radiopacity The radiopacity of dental materials permits the differentiation of tooth-coloured restorative materials from the natural tooth structure or caries on X-rays. The radiopacity is determined in comparison to aluminium. Radiopacity of self-curing luting composites Radiopacity / %Al Multilink Implant Panavia 21 RelyX Unicem Fig. 6: Radiopacity of three luting composites (Ivoclar Vivadent AG, R&D)

11 Scientific Documentation Multilink Implant Page 11 of Water absorption and water solubility The absorption of water may result in an increase in volume (expansion) and, as a consequence, damage to the restoration. The higher the hydrophilicity of the composite, the higher its tendency to absorb water and to swell. On the other hand, the luting composite must have a surface that is compatible with the hydrophilic dental material to ensure sufficient wetting. Water absorption of self-curing luting composites Water absorption / µg/mm Multilink Implant Panavia 21 RelyX Unicem Fig.7: Water absorption of luting composites after self-curing (Ivoclar Vivadent AG, R&D) Water absorption was determined after 7 days of water storage according to ISO Adhesion to implant abutments Artificial tooth stumps on implants are known as abutments. These abutments are mainly made of titanium or zirconium oxide. Sometimes, abutments are also cast from metal Shear bond strength on zirconium oxide (Y-TZP, IPS e.max ZirCAD MO0) To test the shear bond strength to zirconium oxide, rectangular platelets were subjected to abrasive blasting with aluminium oxide (100) at 2.5 bar and then cleaned with ethanol in an ultrasonic bath. For experimental purposes, a higher jet pressure than the one recommended by the manufacturer was applied. Upon completion of the blasting procedure, the individual luting agents including the primer recommended by the manufacturer were applied according to the corresponding instructions for use and cured for 30 minutes with the exclusion of light, applying a contact pressure of 500 g. Shear testing was carried out in a Zwick universal testing machine at an advance speed of 0.8 mm/min.

12 Scientific Documentation Multilink Implant Page 12 of Shear bond strength (MPa) Multilink Implant RelyX Unicem Aplicap RelyX Unicem Clicker Ketac Cem Panavia F 2.0 Fig. 8: Shear bond strength on zirconium oxide platelets (Ivoclar Vivadent AG, R&D) The two luting composites Multilink Implant and Panavia F 2.0 achieved the highest bond strength values under the given conditions Shear bond strength on titanium A similar experimental design as described in Section was used to determine the shear bond strength of three luting agents on titanium platelets Shear bond strength (MPa) Multilink Implant RelyX Unicem Clicker SpeedCEM Fig. 9: Shear bond strength on titanium after self-curing (Ivoclar Vivadent AG, R&D)

13 Scientific Documentation Multilink Implant Page 13 of 17 Multilink Implant, as well as SpeedCEM, show comparatively high shear bond strength values under the given conditions Shear bond values on different metals and ceramics Multilink Implant has been developed for bonding crowns to implant abutments. In addition, it should be ensured that the bond functions not only in relation to the abutment materials but also in relation to all the other systems involved in the implant restoration. Monobond Plus, which has been designed for universal applications, is always used as bonding agent. The following materials were tested: Aquarius H (high-gold alloy) Titanium Capricorn (Ag/Pd alloy) Al-Cube (aluminium oxide ceramic) IPS e.max ZirCAD (zirconium oxide ceramic) IPS Empress Esthetic (leucite glass-ceramic) IPS e.max Press LT (lithium disilicate glass-ceramic) The surfaces were subjected to abrasive blasting with corundum or etched with a ceramic etching gel according to the manufacturer s recommendations. After Monobond Plus had been applied, a cylinder made of Tetric EvoCeram was bonded to the substrate using Multilink Implant. While applying a load of 500 g, the samples were illuminated from two sides with a bluephase polymerization light (HIP mode, 1200 mw/cm 2 ). Subsequently, the test samples were stored in dry conditions for 60 min at 37 C and then stored in water for 23 h at 37 C. Before the shear bond strength was determined, the samples were submitted to 5000 cycles of thermocycling in a temperature range from 5 C to 55 C. Shear bond testing was performed in a Zwick universal testing machine at an advance speed of 0.8 mm/min. 35 Shear bond strength (MPa) Aquarius H Titanium Capricorn Al-Cube ZrO2 IPS Empress Esthetics e.max Press Fig.10: Shear bond strength values of Mulilink Implant on different substrates after thermocycling (Ivoclar Vivadent AG, R&D) Even after artificial ageing, Multilink Implant achieves comparatively high bond strength values. We may expect that the Multilink Implant / Monobond Plus system ensures safe adhesion of these substrates in clinical applications.

14 Scientific Documentation Multilink Implant Page 14 of Bonding of zirconium oxide abutments on titanium bases Multilink Implant is also suitable for bonding customized implant abutments made e.g. of zirconium oxide to titanium sleeves. This cementation procedure takes place at room temperature outside the oral cavity. Because of the self-curing capacity of Multilink Implant, cementation can be conducted by self-curing only or in combination with light-curing. After having been light-cured for 120 sec in a Spectramat SP1 unit (polymerization unit for laboratories), the test samples were subjected to tensile strength testing in a Zwick universal testing machine. The luting agents tested in this experimental were applied according to the manufacturer s recommendations. Consequently, the zirconium oxide and titanium surfaces were conditioned with Monobond Plus for 60 seconds in conjunction with Multilink Implant Pull-off force / N Panavia F 2.0 RelyX Unicem AGC Cem Multilink Implant Light polymerization - Length 120 sec Fig.11: Pull-off force of zirconium oxide samples from titanium bases after cementation with different luting agents (MDT R. Meyer, Wiernsheim) Multilink Implant proved to provide the most stable bond under the given conditions.

15 Scientific Documentation Multilink Implant Page 15 of Clinical Studies with Multilink and Multilink Automix Multilink has already been used and documented in a large number of clinical studies on the cementation of restorations. The Scientific Documentation on Multilink Automix provides an updated overview of these studies. Multilink has been commercially available since 2003 and has performed very well. In 2005, the self-curing luting agent Multilink Automix was launched. As this material comprises camphorquinone as an additional ingredient, it offers an optional light-curing possibility. In addition, a conditioning agent Metal/Zirconia Primer was developed to enhance the adhesion to restorations made of metal alloy or oxide ceramic. Multilink Automix was improved in 2008 to facilitate the removal of excess cement. In the course, the photoinitiator was optimized. Multilink Automix has sometimes already been used for the final placement of implant-borne abutments. However, such applications involved relatively long curing times. Controlled clinical studies with Multilink and Multilink Automix were conducted by the following investigators/study centres: M. Ferrari, Livorno G. Arnetzl, Graz J. A. Sorensen, Portland D. Nathanson, Boston D. Fasbinder, Ann Arbor St. Wolfart, Aachen (multi-centre study) M. Kern, Kiel A. Peschke, Schaan (In-house clinic at Ivoclar Vivadent AG) Multilink Implant cures rapidly without necessitating the application of Multilink Primer A and B and excess material can be easily removed using the quarter technique. It is therefore ideally suited for use as a luting agent on implant abutments in combination with an appropriate primer (Monobond Plus). 5. Biocompatibility Data The cytotoxicity, genotoxicity, and carcinogenicity of Multilink Implant were tested according to ISO ) XTT Test (Cytotoxicity Assay in vitro: Evaluation of materials for Medical Devices) Harlan Test Report ; ) Ames-Test (Salmonella Typhimurium Reverse Mutation Assay) Harlan Test Report ; Both the cytotoxictiy test and the mutagenicity test did not show any toxicological risk. Given the composition of the composite, which contains components comparable to those used for most of the established dental composites, nothing else has to be expected.

16 Scientific Documentation Multilink Implant Page 16 of Literature G. Oilo: Luting cements: a review and comparison. Int. Dent. J. 41, 81 (1991) S. F. Rosenstiel, M. F. Land, B. J. Crispin: Dental luting agents: a review of current literature. J. Prosth. Dent. 80, 280 (1998) M. Ferrari, A. Vichi, S. Grandini, C. Goracci: Efficacy of a self-curing adhesive resin cement system on luting glass-fiber posts into root canals: an SEM investigation. Int. J. Prosthodont. 14, 543 (2001) S. Grandini, M. Ferrari, P. Balleri, A. Vichi: Clinical trial of fiber posts luted with self-curing ExciTE in combination with an experimental resin cement. J. Dent. Res. 81 (Spec. Iss. A) # 198 (2002) A. Dagostin, M. Sierraalta, A. Macedo, M.E. Razzoog: Bonding properties of an experimental selfcuring resin cement. J. Dent. Res. 82 (Spec. Iss. B) # 2615 (2003) F. Monticelli, C. Goracci, P. Balleri, S. Grandini, M. Ferrari: Clinical behaviour of translucent fibre posts and luting and restorative materials: a 2-year report. Vortrag bei ConsEuro 2003 in München (Abstract-Band S. 46) F. Monticelli, S. Grandini, C. Goracci, M. Ferrari: Clinical behaviour of translucent fibre posts and luting and restorative materials: a 2-year prospective study. Int. J. Prosthodont. 16, 593 (2003) U. Salz, G. Arnetzl: Neues selbsthärtendes, selbstätzendes Komposit-Befestigungsmaterial. ZWR Das Deutsche Zahnärzteblatt 116, 607 (2007) L. Ceballos, M. A. Garrido, V. Fuentes, J. Rodriguez: Mechanical characterization of resin cements for luting fiber posts by nanoindentation. Dent. Mater. 23, 100 (2007) D. Edelhoff, M. Ozcan: To what extent does the longevity of fixed dental prostheses depend on the function of the cement? Working Group 4 materials: cementation. Clin. Oral Impl. Res. 18 (Suppl. 3), 193 (2007) A. D. Vrochari, G. Eliades, E. Hellwig, K. T. Wrbas: Curing efficiency of four self-etching, self-adhesive resin cements. Dent. Mater. 25, 1104 (2009) R. Meyer: Verklebung: Individuelle Aufbauten auf Titanbasen. Zahntech. Mag. 14, 94 (2010)

17 Scientific Documentation Multilink Implant Page 17 of 17 This documentation contains a survey of internal and external scientific data ( Information ). The documentation and Information have been prepared exclusively for use in-house by Vivadent and for external Vivadent partners. They are not intended to be used for any other purpose. While we believe the Information is current, we have not reviewed all of the Information, and we cannot and do not guarantee its accuracy, truthfulness, or reliability. We will not be liable for use of or reliance on any of the Information, even if we have been advised to the contrary. In particular, use of the Information is at your sole risk. It is provided "as-is", "as available" and without any warranty express or implied, including (without limitation) of merchantability or fitness for a particular purpose. The Information has been provided without cost to you and in no event will we or anyone associated with us be liable to you or any other person for any incidental, direct, indirect, consequential, special, or punitive damages (including, but not limited to, damages for lost data, loss of use, or any cost to procure substitute information) arising out of your or another s use of or inability to use the Information even if we or our agents know of the possibility of such damages. Ivoclar Vivadent AG Research and Development Scientific Service Bendererstrasse 2 FL-9494 Schaan Liechtenstein Contents: Dr Thomas Völkel Issued: March 2010