Filtek Supreme XT Universal Restorative System. technical product profile. Filtek

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1 Filtek Supreme XT Universal Restorative System technical product profile Filtek TM

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3 Table of Contents Introduction Product Description Composition Shades Shade Basics Indications for Use Background Nanotechnology Filler Development Dentist-Guided Development Shade Development Physical Properties Polish Retention Volumetric Shrinkage Fracture Toughness Flexural Modulus Flexural Strength Compressive and Diametral Tensile Independent Investigations Polymerization Shrinkage Wear Technique Guides Instructions For Use Warranty Limitation of Liability

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5 Introduction Product Description 3M ESPE Filtek Supreme XT Universal Restorative material is a visible-light activated, direct restorative nanocomposite designed to deliver optimized esthetic properties for both single or multi-shade restorations. As with its predecessor, Filtek Supreme Universal Restorative, Filtek Supreme XT universal restorative is offered in dentin, body, enamel and translucent opacities. All shades, with the exception of translucent, white and extra-white shades, have been enhanced to help the clinician more easily recreate the lifelike appearance of natural dentition. As described on page 12, optimization of the shading system has been achieved through an intensive analysis of how the three color attributes - value, hue and chroma, contribute to the visual perception of an esthetic composite restoration. The result are more vibrant, lifelike restorations created, in part, by a slight increase in the value or brightness of these shades. To aid in the shade selection process, a shade selection wheel is available with recommendations for both unsupported (e.g. Class III, IV) and supported (e.g. Class I, II and V) restorations. All other compositional parameters of Filtek Supreme XT universal restorative are identical to the original formula. Material properties such as handling, strength, polish retention and polymerization shrinkage are unchanged. Therefore, much of the data related to these properties as described in the Filtek Supreme universal restorative product profile has been retained as originally presented. Filtek Supreme XT universal restorative is designed for use in anterior and posterior restorations. All shades, except for the Translucent shades, are radiopaque. A Clear Translucent shade is also now available. Composition The resin system is the same reduced shrinkage resin as found in 3M ESPE s Filtek Z250 Universal Restorative and Filtek P60 Posterior Restoratives: BIS-GMA, BIS-EMA (6), UDMA with small amounts of TEGDMA. Translucent shades contain a combination of a non-agglomerated/non-aggregated, 75 nm silica nanofiller, and a loosely bound agglomerate silica nanocluster consisting of agglomerates of primary silica nanoparticles of 75 nm size fillers. The cluster size range is 0.6 to 1.4 microns. The filler loading is 72.5% by weight. The Translucent shades are not radiopaque. All of the remaining shades contain a combination of a non-agglomerated/non-aggregated, 20 nm nanosilica filler, and loosely bound agglomerated zirconia/silica nanocluster, consisting of agglomerates of primary zirconia/silica particles with size of 5-20 nm fillers. The cluster particle size range is 0.6 to 1.4 microns. The filler loading is 78.5% by weight. These shades are radiopaque. Shades Dentin opacity (Highest opacity): A1D, A2D, A3D, A4D, A6D, B3D, C4D, C6D Body opacity: A1B, A2B, A3B, A3.5B, A4B, B1B, B2B, B3B, C1B, C2B, C3B, D2B Enamel opacity: A1E, A2E, A3E, B1E, B2E, D2E Specialty shades: WE (White Enamel), WB (White Body), WD (White Dentin), XWB (Extra White Body), XWD (Extra White Dentin) Translucent opacity: V(iolet), G(ray), Y(ellow), C(lear) Shade selection is accomplished referencing the VITAPAN classical shade guide. A Shade Selector Wheel, developed for use with Filtek Supreme XT universal restorative, is used to provide guidance in choosing multiple shades to build a restoration. 5

6 Shade Basics Color Hue Describes whether the color appears red, yellow, blue, etc.. Shade Family (Hue) A shades Red-brown character B shades Red-yellow character C shades Grey character (lower value) D shades Red-grey character (lower value) Chroma is the intensity of the shade. The higher the number, (e.g. A3 vs. A1) within a shade family, the more intense the color (A3 is more intense than A1). The value (amount of white or black) is higher (whiter) for the A and B shades. The C and D shades have lower value (grayer) than the equivalently numbered A and B shades. Studies have indicated that tooth color, in adult teeth, is determined primarily by dentin. The enamel layer plays a very minor role in the actual tooth color. In young patients, teeth are brighter (higher value) and less translucent. With age, the enamel layer thins and becomes more translucent, exposing more dentin so teeth appear darker (lower value) particularly in the gingival third. Areas of highest intensity of color (chroma) will be in the gingival region of the tooth due to a thinner enamel layer so the dentin is more visible. The body shade is a combination of the dentin color and the slight contribution by the enamel layer color and surface morphology. Literature suggests that the intensity of the body is 1-2 shades lighter than the gingival area. The incisal area exhibits a high degree of translucency as the amount of dentin present is decreased towards the incisal edge. pacity Color Regions Dentin shades are the most opaque (lowest translucency), Body shades are less opaque (more translucent), then Enamel shades, and finally the Translucent shades are almost transparent. 1. When light contacts a tooth: Enamel diffuses and transmits light. If the dentin layer is very thin or if there is no dentin behind the enamel layer (as in the incisal edge) some of the light is transmitted through the tooth to the oral cavity. The oral cavity can reflect light back through the enamel. 6 Enamel also scatters blue light preferentially and this provides an opalescent effect at the incisal edge.

7 When light encounters dentin, some of the light is absorbed and some is reflected back through the enamel. The light that is reflected and refracted back to the eye produces the color of the tooth. The surface texture of a tooth plays a role in the perceived color, i.e., a smoother surface will appear whiter (or higher value) than an irregular surface. Shade Selection Tips and Hints for Filtek Supreme XT Universal Restorative 1. After pumicing the surface to remove any extrinsic stains, determine the shades needed for the restoration prior to tooth preparation or rubber dam placement. A tooth that is desiccated will be lighter than normal. Therefore, a shade taken on a desiccated tooth will be lighter than the tooth upon rehydration. 2. During shade selection, If one shade is to be used: Select the Body shade by examining the center (body) portion of the tooth. Choose the composite shade most closely approximating the center portion of the VITAPAN classical tooth tab. If more than one shade is to be used (This technique can mimic actual tooth structure and increase the vitality of the final restoration): Select the Dentin (or Body) shade by examining the exposed dentin or the gingival area of the tooth. Choose the composite shade most closely approximating the cervical portion (grinding off the neck of the tab has been recommended by some) of the VITAPAN classical tooth tab. Select the Body shade by examining the center (body) portion of the tooth. Choose the composite shade most closely approximating the center portion of the VITAPAN classical tooth tab. Select the Enamel shade by examining the proximal or incisal area of anterior teeth or from the cusp tips of posterior teeth. Choose the composite shade most closely approximating the incisal portion of the VITAPAN classical tooth tab. A Translucent shade (in the same color family) may be used to impart high translucency and increase the depth of the restoration. 3. Do a mock up of the restoration prior to etching. The color of a composite will be affected by its thickness. Composites may change color upon curing. Place and cure composite material in the approximate thickness and area of the planned restoration. btain agreement with the patient of shade match. Remove mock-up easily by flicking it off the tooth with an explorer. 4. Evaluate shade match of the tabs and mock-up under different lighting conditions. 5. When finishing and polishing the restoration, mimic the surface morphology of adjacent teeth. 7

8 Shade Wheel To aid in the shade selection process, 3M ESPE Filtek Supreme XT incorporates a unique (patent applied for) shade selector wheel. nce a shade has been selected using the Vita Classical guide, the selector offers recommendations for single shade, two-shade, or multi-shade restorations. The figure at right indicates the proposed shade combinations for a Class IV restoration determined to be shade A1. Several options are offered, with final choice depending upon the size and esthetic requirements of the restoration. Simpler shade recommendations are given for restorations that are supported by tooth structure as shown in the upper right figure. Posterior restorations are an ideal place to start exploring the esthetic options offered by the shade layering technique. It should be noted that this tool is a guide only. Final results will be influenced by the thickness of composite layers, surrounding tooth structure, adjacent teeth, etc. Further, the layering diagrams depicted on the shade guide are offered as potential solutions in creating certain esthetic effects. For instance, the translucent shade may be applied internally as indicated to create translucency at the incisal third of a Class IV restoration. Alternatively, while not diagrammed, the translucent shade may be applied as the last facial or occlusal increment to create depth. As using the translucent shade in this manner may tend to decrease the overall value of the restoration, choosing a shade one step lighter for the increment immediately below the translucent shade may moderate this effect. 8

9 Indications for Use 3M ESPE Filtek Supreme XT Universal Restorative is indicated for use in the following types of restorations. Direct anterior and posterior restorations Sandwich technique with glass ionomer resin material Cusp buildup Core buildup Splinting Indirect anterior and posterior restorations including inlays, onlays and veneers Background Nanotechnology Nanotechnology is offering us the ability to design materials with totally new characteristics. (ttilia Saxl, CE of the The Institute of Nanotechnolgy) Worldwide government sponsored R&D has been steadily increasing. Expenditures in western Europe, Japan, US and other countries grew almost 3.5 times between 1997 and 2002, the year Filtek Supreme Universal Restorative was introduced. In 2005, expenditures in these same countries have increased five times over that spent in 97 with the US leading the way with over a billion dollars budgeted for nanotechnology research by the National Science Foundation for A nanomer is 1/1,000,000,000 (one-billionth) of a meter or 1/1000 of a micron. This is about 10 times the diameter of a hydrogen atom or 1/80,000 of a human hair. Frequently, nanotechnology is used to describe research or products where critical component dimensions are in the range of 0.1 to 100 nanomers. In theory, nanotechnology can be used to make products lighter, stronger, cheaper, and more precise. If this type of material was used to make an airplane instead of metal, the airplane could weigh 50 times less but be just as strong. ne of the major initiatives of this technology is in creating value-added products. From scratchresistant lacquers and UV protective coatings for the automobile industry to stain free clothing, nanotechnology is enhancing the products we use everyday. For 3M ESPE, the goal was to use nanotechnology to create a composite that offers the polish retention of a microfill with the strength of a hybrid composite. The result was the introduction of Filtek Supreme Universal Restorative. Filler Development These TEMs show the difference in filler particle size between traditional hybrid composites and the nanofillers used in Filtek Supreme XT universal restorative. The relatively large filler particle in hybrids allow for high filler loading which increases the strength of the composite. 3M ESPE has developed fillers from a liquid form (sol-gel chemistry) since the zirconia/silica filler was used in 3M ESPE P50 Restorative. The Filtek Supreme XT universal restorative nanocomposite contains a unique combination of two types of nanofillers (5-75 nm) and nanoclusters. Nanoparticles are discrete nonagglomerated and nonaggregated particles of nms in size. Nanocluster fillers are loosely bound agglomerates of nano-sized particles. The agglomerates act as a single unit enabling high filler loading and high strength. 9

10 (left to right) Hybrid, Nanoparticle, Nanocluster Traditional microfills are made from fumed silica with an average particle size of 40 nm. Typically, the primary particles tend to aggregate (the degree of aggregation varies depending on the filler used in the microfill product). Further breakdown of any aggregated particles into smaller entities is difficult if not impossible to achieve. Fumed silica is prepared by a pyrogenic process. The structure of the microfill fillers results in relative low filler loading. Most manufacturers add prepolymerized filled resin particles to increase filler loading. This prepolymerized filler is made by adding the fumed silica filler to resin. The mixture is polymerized, then ground to form small particles. These particles are then added to more resin and silica filler. Even using this process, microfills have a substantially lower filler loading than hybrids resulting in lower strength. Additionally, residual methacrylate groups bind the prepolymerized particles to the resin matrix. The effectiveness of this bond is impacted by the amount of residual double bonds on the surface of these particles. During the polymerization of the prepolymerized filler the reaction is driven to near completion. Hence the bond of the prepolymerized filler particles to the resin is weaker than desired and breakdown frequently occurs at this interface. Microfills containing only silica filler are not radiopaque. These properties have limited the usefulness of microfills, particularly in the posterior area. SEM ultramicrographs of hybrid and microhybrid composites (courtesy of Dr. J. Perdigao, University of Minnesota) Hybrids and microhybrids contain a broad range of particle sizes. A wide range of particle sizes can lead to high filler loading with resultant high strength. While they may contain a small fraction of filler particles in the nanomer particle size range, they also contain a range of substantially larger filler particles which influences the optical properties of these composites and detracts from polish retention. The average particle size of hybrids and microhybrids is typically below 1 micron but above 0.4 microns. The upper particle size range can extend to well over 1 micron as the SEMs reveal below. 4 Seasons, EsthetX, Premise, Tetric Evo Ceram and Grandio 25,000x (courtesy of Dr. J. Perdigao, University of Minnesota) 10

11 These SEMs and graphics reveal the mechanism of abrasion and loss of gloss (polish) for composite products. When hybrids are subjected to abrasion, the resin between and around the particles is lost leading to protruding filler particles (bumps). Eventually the filler particles are plucked from the surface resulting in craters. These bumps and craters create a roughened surface resulting in loss of reflectivity (loss of polish retention) of the composite surface. Microfills have proven to retain their polish (surface reflectivity) over time. As the surface of a microfill becomes abraded, the primary filler particles (40 nm silica particles) are lost at a similar rate as the surrounding resin. However, since prepolymerized filler particles are only marginally stronger than the matrix resin, the overall composite is not very resistant to fracture. The graphic (below left) is a composite made using nanoclusters alone. Since the nanocluster filler particles consist of loosely bound agglomerates of nano-sized filler particles, during abrasion, the primary particles, (nanomer-sized) not the clusters themselves, can be worn away. This increases the polish retention of the cured composite when compared to traditional hybrid composites. 3M ESPE Filtek Supreme XT Universal Restorative is formulated using both nanoparticle and nanocluster fillers (below right, courtesy of Dr. J. Perdigao, University of Minnesota). The combination of nanomer sized particles to the nanocluster formulations reduces the interstitial spacing of the filler particles. This provides for increased filler loading, better physical properties and improved polish retention when compared to composites containing only nanoclusters. The Dentin, Enamel and Body shades are formulated with zirconia/silica nanocluster, which imparts the radiopacity. However this formulation could not provide the high translucency option required in many incisal areas. The use of silica nanoclusters instead of zirconia/silica in the Translucent shades formulations provided a very highly translucent composite. Additionally, the combination of silica nanoparticles with the silica nanocluster imparted gloss retention even greater than the Dentin, Enamel and Body shades. Resin System Examination of the 3M ESPE Z100 Restorative composition established the belief that modifying the resin system could result in enhanced properties. The Z100 resin system consists of BIS-GMA (Bisphenol A diglycidyl ether dimethacrylate) and TEGDMA (tri[ethylene glycol] dimethacrylate). Many other commercially available composites contain these two components in varying concentrations. H bis-gma H TEGDMA 11

12 The high concentration of a low molecular weight component, TEGDMA resulted in a system that offered the following advantages: The resultant high number of double bonds per unit of weight on a flexible backbone afforded the opportunity to have a high conversion of double bonds during polymerization. The low viscosity of the resin permits higher filler loading than with BIS-GMA alone. The high degree of crosslinking and compact molecule creates a very hard resin matrix. However, the TEGDMA concentration also allows for some opportunities for improvements. The relatively low molecular weight of TEGDMA contributes to the aging of an uncured composite especially in capsules where there is a high ratio of surface area to volume of paste. This material is labile enough to migrate into the capsule walls leading to a thickening of the composite. The low molecular weight and resultant high number of double bonds per unit of weight creates a high degree of crosslinking creating a very rigid, stiff composite with a relatively high amount of shrinkage. bis-ema(6) EMA6 N H UDMA N H A resin system introduced with 3M ESPE Filtek Z250 Universal Restorative is now being used in Filtek Supreme XT universal restorative. The resin consists of three major components. The majority of TEGDMA (in the Z100 restorative system) was replaced with a blend of UDMA (urethane dimethacrylate) and Bis-EMA(6) 1 (Bisphenol A polyetheylene glycol diether dimethacrylate). TEGDMA is used in minor amounts to adjust the viscosity. UDMA and Bis- EMA(6) resins are of higher molecular weight and therefore have fewer double bonds per unit of weight. The high molecular weight materials also impact the measurable viscosity. However, the higher molecular weight of the resin results in less shrinkage, reduced aging and a slightly softer resin matrix. Dentist-Guided Development Shade Development Extensive surveys of dentists showed they desire a close match of a composite to the VITAPAN classical shade guide. During development of the original 3M ESPE Filtek Supreme Universal Restorative, extensive work was carried out to establish color targets based on the VITAPAN shade guide to meet this expressed need. This effort proved beneficial, as determined in the orginal field evaluation, as the shade match of Filtek Supreme universal restorative to the VITAPAN classical shade guide was rated higher than other composites match to either the Vita shade guide or their own shade guide. Further, the chameleon effect of Filtek Supreme universal restorative was rated better than their current composite. Within two years of its introduction in 2002, Filtek Supreme universal restorative became one of the best selling universal composites in the US market, and one of the leading composites in the world. Clinicians appreciated the range of shades and opacities, excellent esthetics and polish retention, and the universal indications of this nanocomposite. Filtek Supreme XT Universal Restorative builds on this success but makes the excellent esthetics even easier to obtain Bis-EMA(6) contains, on average, 6 ethylene oxide groups per Bisphenol A grouping.

13 Measuring color The color of a composite can be modeled in terms of tri-chromatic color theory a theory based on the physiologic response of the three major types of color receptors in the human eye including the transformation of this response into six channels of color perception. Two of the channels are achromatic and represent lightness (or value) from white to black (L*). The other four channels are chromatic as represented by the red-green axis (a*) and yellow-blue axis (b*) (below left). We can measure and describe the color of a surface spectroscopically in similar terms. The model that has gained the most use throughout various industries for the spectroscopic characterization of color, is the CIELAB model (below left). Any surface color can be defined in color space by the their L*a*b* coordinates as shown. The three color attributes described earlier, hue, value and chroma, can also be represented in this model (below right). Although many composites on the market use shade designations based on the Vita system, it is not true that similar shades from different manufactures share the same color coordinates when measured spectroscopically. The diagram on the right reveals the large variation in A3 shades as represented by the a*/b* color plane. We can describe differences such as those represented here by calculating ΔE, the difference between two sets of L*a*b* coordinates. Generally, for most people, perceived differences between two colors occur at a threshold around ΔE of 3. For the A3 shades examined, the maximum color difference, ΔE, was over 14, a very perceptible difference. Consultation with Clinicians While there has been great acceptance among clinicians of the shade matching ability of 3M ESPE Filtek Supreme Universal Restorative, 3M ESPE set out towards the goal of increasing the satisfaction of those already using Filtek Supreme universal restorative and making it easier for those new to Filtek Supreme universal restorative to transition from their current composite. ver a period of two years, 3M ESPE worked with clinicians in the US and Europe to optimize the shading of Filtek Supreme universal restorative. The key determinant in this process was the translation of the clinicians perceptual characterization of the color attributes, hue, value and chroma into the colorometric terms L*a*b*. This afforded an iterative shade optimization involving the clinician and our 3M ESPE laboratory that could be repeated for various indications, from unsupported (Class III and IV) to supported (Class V, I/II) restorations. The result of this collaboration is realized, as shown at right for the A-Body shades, primarily as a slight increase in value, a broader differentiation in chroma and, for some of the shades, small changes in hue. 13

14 The optimization can be appreciated by the figure at right where the current and new shades are applied to a Vita shade tab. The improvement is most readily noticed in unsupported areas (those areas of a restoration that are not backed by tooth structure such as occurs with Class III and IV restorations). The figure illustrates the difference between 3M ESPE Filtek Supreme and Filtek Supreme XT universal restorative applied to a shade tab. Note the improvements, especially on the unsupported areas of the tab. This means better results in the critical Class III and IV restorations. The second illustration was made by using a filter to force the image to be made of only 4 colors. This technique, know as posterizing, highlights both the difference between the two products as well as the blend achieved with Filtek Supreme XT universal restorative. nce the shade targets were defined, a field evaluation was conducted with over 250 clinicians in the US and Europe who were currently using Filtek Supreme Universal Restorative. Clinicians were asked to place the new shades in anterior and posterior restorations using both single shade and multi-shade techniques. ver 6,000 of these were placed in Class III, IV and V restorations which allowed a critical assessment of the esthetic capabilities of the new shades. Upon analyzing the results, a majority of the dentists responded that the optimized shades yielded an overall better esthetic result and their desired esthetic result was easier to achieve. This was true whether they were using a single shade or multi-shade technique. Shade System, Shade Selection and Customer Defined Handling Various customer focused tools were used in defining the shading system and handling for Filtek Supreme Universal Restorative. The following summarizes the customer research applicable to Filtek Supreme XT Universal Restorative. Conjoint and Focus Panel ne hundred four dentists in three locations across the US participated in this study. Dentists were screened to ensure esthetics was a key factor of their practice. There were three objectives in this initial customer research activity. To determine and understand what constitutes esthetics and how dentists articulate these attributes To determine procedures dentists undertake to achieve acceptable esthetics To design a product that would suit their needs During the focus groups it was clear that dentists who market their practices as esthetic fall into one of two categories. Both groups of dentists provide the level of esthetic result demanded by their patient base. However, the detail and average time spent generating these esthetic results varies greatly. ne group approaches dentistry as almost an art form. They require more options in shades and opacities frequently using multiple shades (and opacities) in one restoration. The other group most frequently uses one shade or possibly two shades for a restoration. Both groups of these dentists buy hybrids, microhybrids and microfills for their esthetic composites of choice. The difference lies in how they use the products to create the restorations. 14 Most of the dentists interviewed felt comfortable with their knowledge and understanding of the VITAPAN classical shade guide for their shade selection. There were positive and negative features associated with shades guides currently available from composite manufacturers. Frequently, attributes that were considered positive (a shade recipe to build a restoration) by some dentists,

15 were considered a negative by others. Most of the dentists interviewed also agreed that most current composite manufacturers shade guides do not match the composite. Finally, a conjoint study was used to assist dentists in product design. It was interesting to note that their stated composite product preference did not necessarily reflect the importance of the attributes indicated by the study. Most notably, polymerization shrinkage was found to be the most important attribute, however many of the participants used composites that had shrinkage in the range these dentists deemed unacceptable. However, it was clear that dentists desired a universal product that offered improved polish retention, low shrinkage with short cure times. pinion Leaders Eighteen opinion leaders were invited to share their views regarding case presentations (what they would do and how), education methods, strengths and weaknesses of current composite and shade guide offerings, and finally the nanocomposite system under development. Key findings are detailed below. It is important to gain agreement between patient and dentist as to the level of esthetics required. Shade guides can be used to start the shade selection process, however shade mock-ups using the composite in-vivo are the best way to determine which composite shades are needed to blend with surrounding dentition. The acceptability of the resultant restorations can be influenced by many factors including shades selected, depth of color and re-creation of the natural tooth appearance (e.g., provided by layering translucent materials over less translucent materials or creating appropriate translucency along incisal edge), surface polish and surface morphology and patients and dentists preferences. Several opinion leaders were consulted during the entire development process to provide guidance regarding shade and opacity offerings, handling and shade guide needs. Shade Guide Discussions Throughout the development process, discussions were held with dentists (and opinion leaders) regarding shade guide usage. Generally speaking, current shade guides provided by composite manufacturers do not satisfy needs of dentists. Plastic shade guides cannot accurately match the composite and, therefore, the final restoration. Most of these guides are monochromatic (1-color) shade tabs made of plastic. A mismatch between composite and shade tab is inherent due to metamerism (materials may appear to match under certain lighting conditions but not match under other lighting conditions). Frequently the plastic used does not represent the difference in opacity levels that may impact the perceived color. Shade tabs made from actual composite are expensive to manufacture. Ultimately, it was found that dentists do not perceive a price/value relationship with shade guides. Some shade guides provide polychromatic tooth tabs. These tabs may or may not provide the recipe to create the actual shade depicted by the tab. Matching this polychromatic tab with a monochromatic material is difficult. The final color of a restoration is influenced by the shades chosen, the thickness of the layers and the background color (tooth or mouth). So even if the dentist attempts to recreate the tab with shades indicated by the manufacturer, a mismatch will most likely occur. A commonality that was frequently cited was that dentists felt they were well acquainted with the VITAPAN classical shade guide. This is the guide the dentists refer to even if the manufacturer provides its own shade guide. These tabs are comprised of 3 different layers built on an opaque background. So an A2 shade tab is actually three different shades of material. 15

16 Simulated peratory A Simulated peratory study was conducted to determine final handling specifications for 3M ESPE Filtek Supreme Universal Restorative. Eighty-four dentists participated in a blind study (dentists did not know what materials they were handling). The dentists selected were currently using a variety of materials to produce their aesthetic restorations (Figure 1). Less than 30% of the dentists included were 3M ESPE composite users. The study included six experimental pastes, 3M ESPE Filtek Z250 Universal Restorative, EsthetX and Point 4. Each participant evaluated four of the nine pastes by placing them in anterior and posterior restorations in a mannequin heated to 37 C. After placing each paste in anterior restorations, dentists were asked if they Liked or Disliked the handling and a series of questions asking for a rating of specific handling attributes. This procedure was repeated for posterior restorations. The rating scale for Viscosity, Stickiness to instrument, Flow and Resistance to Slump was 1-7 with the ideal rating being a rating of 4. The 7-point rating scale for Ease of shaping, Ease of veneering, and Cavity and marginal adaptation had a rating of 7 indicating highest level of satisfaction or ease. For Ability to pack, the higher the rating the more packable the composite is. Figure 1. Most frequently used composite Each dentist was asked to state their preferred formulation (of the 4 they tested) for anterior, posterior, universal applications and also extrusion force. The Filtek Supreme Universal Restorative formulation garnering the greatest Like response is depicted in the following charts (Figures 2-6). The overall acceptability of Filtek Supreme universal restorative was greater than other leading products included in the study (Filtek Z250, EsthetX and Point 4) in either anterior or posterior restorations. Dentists rated the flow and the ability to hold shape ideal. Dentists rated the viscosity and level of stickiness as close to ideal. 3M ESPE composites, Filtek Z250 and Supreme were preferred in all categories over EsthetX and Point 4 (Figure 7). Figure 2. Handling - Dentin, Enamel and Body shades 16

17 Figure 3 (at left). Dentin, Enamel and Body shades formulation Anterior; 4 is ideal Figure 4 (at right). Dentin, Enamel and Body shades formulation Anterior; 7 is preferred Figure 5 (at left). Dentin, Enamel and Body shades formulation Posterior; 4 is ideal Figure 6 (at right). Dentin, Enamel and Body shades formulation Posterior; 7 is preferred Figure 7. Handling preferences Dentin, Enamel and Body shades Finally, each dentist was asked to evaluate translucent shades formulations. In this case, three experimental pastes, EsthetX and Vitalescence were included in this part of the study. Each dentist evaluated three of the five pastes by placing the composites in Class V and veneer restorations (in a mannequin heated to 37 C). After placing each paste in anterior restorations, dentists were asked if they Liked or Disliked the handling and a series of questions asking for a rating of specific handling attributes. Each dentist was asked to state his or her preferred formulation (of the three they tested) for handling. The overall acceptability of 3M ESPE Filtek Supreme Universal Restorative Translucent shades handling was comparable to other leading products included in the study (EsthetX and Vitalescence ). The stickiness of Filtek Supreme universal restorative translucent shades was comparable to other leading products included in the study (Figures 8-11). Figure 8. Handling - Translucent shades 17

18 Figure 9 (at left). Translucent shades - 4 is ideal Figure 10 (at right). Translucent shades - 7 is preferred Figure 11. Preferences - Translucent shades Physical Properties The objective of 3M ESPE in designing composites has always been to deliver both high strength and the best possible esthetic result. Resin and filler technology, however, has limited our ability to deliver both of these requirements in a single product. Microfills have been known for excellent polish and, perhaps more important, polish retention. While excellent for certain indications, most manufacturers limit the indications for use because the strength characteristics of microfills are not up to the excellent levels achieved by today s hybrid composites. Hybrids, on the other hand, have proven track records in all areas of direct restorative dentistry. While the new hybrids display excellent clinical performance, including very low wear, the good initial polish can dull with time in a clinical setting. 3M ESPE chose to take a radically different approach in the design of Filtek Supreme Universal Restorative, using novel (and patented!) techniques in nanotechnology to create a composite that displays the polish and polish retention of a microfill while maintaining the strength and wear properties of a modern hybrid. Polish Retention Standard Test Method for Specular Gloss (ASTM D ) 18 A rectangular sample was cured with a Visilux 2 unit for 80 seconds followed by additional curing for 90 seconds in a Dentacolor XS light box (Kulzer, Inc., Germany). Samples were mounted with double sized adhesive tape (Scotch Brand Tape, Core series , St. Paul, MN) to a holder. The mounted examples were polished using a Buehler ECMET 4 Polisher

19 with an AUTMET 2 Polishing Head. The following sequence of abrasive was used for each sample 320 grit, 600 grit silicon carbide abrasive, 9mm diamond polishing paste, 3mm diamond polishing paste and finally a Master Polishing Solution. A micro-tri-gloss instrument (BYK Gardner, Columbia, MD) was used to collect photoelectric measurements of specularly reflected light from the sample surface after polishing and after tooth brushing. The procedure described in ASTM D (Reapproved 1994) Standard Test Method for Specular Gloss, for measurements made at 60A1 geometry was followed. Initial gloss after polishing was measured for initial sample. Gloss readings were recorded after 500 toothbrushing cycles. Each sample was brushed with an RAL B 40 medium Straight toothbrush (ral B Laboratories, Belmont, CA.) using CREST Regular Flavor (Proctor & Gamble, Cincinnati, H) toothpaste. The toothbrush and sample were mounted on a device that controlled the stroke length and force on the toothbrush head. The polish retention of 3M ESPE Filtek Supreme Universal Restorative is similar to traditional microfill type products. The polish retention of Filtek Supreme Universal Restorative is improved versus hybrid and microhybrid type products (Figures 12, 13). % Filtek Supreme - Translucent Filtek Supreme - All other shades Filtek A110 Durafill Heliomolar Renamel Microfill Figure 12. Polish retention % Filtek Supreme - Translucent Filtek Supreme - All other shades EsthetX EsthetX Point Vitalescence Renamel Hybrid Tetric Ceram % TPH Herculite XRV Filtek Z250 Filtek Supreme - DEB Shades Filtek Supreme - Trans Shades Microfill Microhybrid Hybrid Figure 13. Polish retention 19

20 Surface SEMs After Toothbrush Abrasion The SEMs below were taken of the sample surfaces after toothbrush abrasion. These SEMs support the gloss retention data reported above. Filtek Supreme Translucent shades formulation The surface maintains surface smoothness even after abrasion. This surface is even more smooth than the surfaces of abraded microfills. Individual nanoparticles of the silica nanoclusters have sheared off at a rate similar to the surrounding silica nanoparticle filled resin matrix. Filtek Supreme Dentin, Enamel and Body shades formulation The surface isn t as smooth as the translucent sample. However, it is apparent that individual nanoparticles have sheared off of the zirconia/silica nanoclusters. The colored cluster surfaces are still flat. Filler particle plucking is not noticeable as there are no craters evident. Filtek A110 Anterior Restorative, Durafill Microfills (Filtek A110 Anterior Restorative, Durafill, Renamel Microfill, Heliomolar ) The surfaces have remained relatively smooth. However, indications of the toothbrush abrasion are more apparent than Filtek Supreme translucent shades formulation. The prepolymerized filler particles are perceptible as they are slightly more abrasion resistant than the surrounding resin matrix. Renamel Microfill, Heliomolar Hybrids and Microhybrids (EsthetX, TPH Spectrum, Vitalescence, Renamel Hybrid, Point 4, Herculite XRV, Tetric Ceram) The surfaces of these composites are markedly different than Filtek Supreme universal restorative or microfills. Surfaces are rough. Filler particles are protruding above the resin matrix. Craters are evident as a result of the loss of individual filler particles (plucking). The resin matrix is clearly lost at a different rate than the fillers. 20

21 EsthetX, TPH Spectrum, Vitalescence Renamel Hybrid, Point 4, Herculite XRV Tetric Ceram Atomic Force Microscopy The objective was to measure polish retention of various composites via atomic force microscopy and compare to a specular gloss test method. Highly polished samples were tooth-brushed (TB) for 2000 strokes and the resulting gloss retention (GR) at 60 was measured by a micro-tri-gloss instrument. The same samples were then subjected to topographical study using an Atomic Force Microscope (AFM) operated in contact-mode. For each sample, the AFM topographical data was used to determine what the far-field optical intensity pattern would be if the sample were illuminated with an ordinary plane wave. The total intensity of the central peak (TIC) corresponds to the specular reflection. The TIC value was compared with the corresponding peak for a perfectly smooth sample to provide the Strehl ratio. Results - The table shows the gloss retention at 2000 strokes of tooth-brushing and the Strehl ratio, both measured at 60. Sample Filtek Supreme Filtek Supreme TPH Tetric Filtek Translucent Standard shades Spectrum Ceram EsthetX A110 GR@ Strehl ratio Higher gloss retention was measured for 3M ESPE Filtek Supreme Universal Restorative translucent shade compared to the microfill. Both translucent and standard shades of Filtek Supreme universal restorative retained gloss better than the microhybrid composites. Gloss retention via atomic force microscopy shows excellent correlation to specular reflection. 21

22 Atomic Force Microscopy used to image the surfaces of a microhybid (left) and Filtek Supreme Universal Restorative translucent shade after toothbrush abrasion. Volumetric Shrinkage A method for determining polymerization shrinkage was described by Watts and Cash (Meas. Sci. Technol. 2(1991) ). In this method, a disc shaped test specimen and uncured paste is sandwiched between two glass plates and light cured through the lower rigid plate. The flexible upper plate is deflected during the polymerization of the test specimen. The less the flexible plate bends, the lower the shrinkage. Deflection is measured and recorded as a function of time. Although this process actually measures linear shrinkage, volumetric shrinkage was closely approximated due to the fact that the dimensional changes were limited to the thickness dimension. The lower the value, the less the shrinkage. In this test, samples were exposed for 60 seconds to a 3M ESPE Visilux 2 Visible Light Curing Unit. The final shrinkage was recorded 4 minutes after the end of light exposure. The polymerization shrinkage of 3M ESPE Filtek Supreme Universal Restorative Dentin, Enamel and Body shades is statistically lower (less shrinkage) than EsthetX, Renamel Hybrid, Renamel Microfill, Point 4, Tetric Ceram, TPH Spectrum, Vitalescence, and Herculite XRV. The polymerization shrinkage of Filtek Supreme universal restorative translucent shades is statistically lower (less shrinkage) than EsthetX, Renamel Hybrid, Renamel Microfill, Point 4, TPH Spectrum, Vitalescence, and Herculite XRV (Figure 14). Figure 14. Shrinkage Hybrids and Microhybrids 110 urafill olar icrofill. shades shades sthetx oint 4 italescence ybrid eram PH XRV Z250 22

23 Wear 3-Body (generalized) Wear The wear rate was determined by an in-vitro 3-body wear test. In this test, composite (1st body) is loaded onto a wheel, which contacts another wheel, which acts as an antagonistic cusp (2nd body). The two wheels counter-rotate against one another dragging an abrasive slurry (3rd body) between them. Dimensional loss during 156,000 cycles is determined by profilometry at regular intervals (i.e., after every 39,000 cycles). As the wear in this method typically follows a linear pattern, the data is plotted using linear regression. The wear rates, i.e., the slope of the lines, are determined. The comparison of rates reduces some of the variability in the test due to sample preparation and can be predictive of anticipated wear beyond the length of the actual test. The in-vitro 3-body wear of 3M ESPE Filtek Supreme Universal Restorative Dentin, Enamel and Body shades is statistically lower (more wear resistant) than 3M ESPE Filtek A110 Anterior Restorative, Durafill VS, Renamel Hybrid, Heliomolar, Renamel Microfill, EsthetX, TPH Spectrum, Tetric Ceram and Herculite XRV. The in-vitro 3-body wear of Filtek Supreme universal restorative translucent shades is statistically lower (more wear resistant) than Durafill VS, TPH Spectrum, Tetric Ceram and Heliomolar (Figure 15). Figure body wear 2-body (localized) Wear 2-body wear estimates were measured at the MDRCBB (University of MN). In this test a stylus (Enamel Cusp) was placed on the restorative material and dragged across the surface. Generally speaking, any volume wear loss less than 0.1mm 3 is acceptable. A wear volume at 0.05mm 3 would be rated good. A wear of 0.05mm 3 for the composite and 0.05mm 3 enamel cusp would be considered well balanced. The conclusion drawn by the MDRCBB is that the wear performance appears satisfactory both numerically and microscopically. Sample Filtek Supreme Enamel Cusp Volume loss Mean depth Volume loss Mean depth (mm 3 ) loss (m) (mm 3 ) loss (m) Filtek Supreme Dentin, Enamel Body shade formulation Filtek Supreme Translucent shade formulation 23

24 Fracture Toughness The values reported for fracture toughness (K 1c ) are related to the energy required to propagate a crack. In this test a short rod of material is cured. A chevron or notch is cut into the cylinder and the parts on either side of the chevron are pulled apart. Below are the values for wet fracture toughness. The fracture toughness of 3M ESPE Filtek Supreme Universal Restorative Dentin, Enamel and Body shades is comparable to Filtek Z250, EsthetX, TPH Spectrum and Vitalescence. The fracture toughness of Filtek Supreme universal restorative Dentin, Enamel and Body shades is higher than 3M ESPE Filtek A110 Anterior Restorative, Durafill, Heliomolar, Renamel Microfill, Point 4, Tetric Ceram and Herculite XRV. The fracture toughness of Filtek Supreme universal restorative translucent shades is higher than Filtek A110, Durafill, Heliomolar, and Renamel Microfill (Figure 16). Figure 16. Fracture toughness Hybrids and Microhybrids Flexural Modulus Flexural modulus is a method of defining a material s stiffness. A low modulus indicates a flexible material. The flexural modulus is measured by applying a load to a material specimen that is supported at each end. The flexural modulus of Filtek Supreme universal restorative Dentin, Enamel and Body shades is: statistically higher than Filtek A110 Anterior Restorative, Durafill VS, EsthetX, Renamel Hybrid, Heliomolar, Renamel Microfill, Point 4, Vitalescence and Tetric Ceram, statistically equivalent to Herculite XRV and TPH, statistically lower than Filtek Z250 universal restorative. The flexural modulus of Filtek Supreme universal restorative translucent shades is; statistically greater than Filtek A110 anterior restorative, Durafill VS, Heliomolar, Renamel Microfill, and Point 4, 24

25 statistically equivalent to EsthetX, Renamel Hybrid, Tetric Ceram and Vitalescence, statistically less than TPH Spectrum, Herculite XRV and Filtek Z250 Universal Restorative (Figure 17). Hybrids and Microhybrids Figure 17. Flexural Modulus Flexural Strength Flexural strength is determined in the same test as flexural modulus. Flexural strength is the value obtained when the sample breaks. This test combines the forces found in compression and tension. The flexural strength of 3M ESPE Filtek Supreme Universal Restorative Dentin, Enamel and Body shades is statistically higher than Filtek A110 anterior restorative, Durafill VS, Renamel Hybrid, Heliomolar, Renamel Microfill, and Tetric Ceram. The flexural strength of Filtek Supreme universal restorative Translucent shades is statistically greater than Filtek A110 anterior restorative, Durafill VS, EsthetX, Renamel Hybrid, Heliomolar, Renamel Microfill, Point 4, TPH Spectrum, Vitalescence and Tetric Ceram (Figure 18). Hybrids and Microhybrids Figure 18. Flexural strength 25

26 Compressive and Diametral Tensile Compressive strength is particularly important because of chewing forces. Rods are made of the material and simultaneous forces are applied to the opposite ends of the sample length. The sample failure is a result of shear and tensile forces. The compressive strength of 3M ESPE Filtek Supreme Universal Restorative Dentin, Enamel and Body shades is statistically equivalent to all other materials tested. Figure 19. Compressive strength The compressive strength of the Translucent shades is statistically higher than 3M ESPE Filtek A110 Anterior Restorative, Tetric Ceram and TPH Spectrum (Figure 19). Hybrids and Microhybrids Diametral tensile strength is measured using a similar apparatus. Compressive forces are applied to the sides of the sample, not the ends, until fracture occurs. The diametral tensile strength of Filtek Supreme universal restorative Dentin, Enamel and Body shades is statistically higher than Filtek A110 anterior restorative, Durafill VS, EsthetX, Heliomolar, Renamel Microfill, and Tetric Ceram. The diametral tensile strength of Filtek Supreme universal restorative translucent shades is statistically higher than Filtek A110 anterior restorative, Durafill VS, EsthetX, Renamel Hybrid, Heliomolar, Renamel Microfill, Point 4, Tetric Ceram, TPH Spectrum and Vitalescence (Figure 20). Figure 20. Diametral tensile strength Hybrids and Microhybrids 26

27 Independent Investigations Numerous independent studies have been performed using 3M ESPE Filtek Supreme Universal Restorative. This includes four in vivo studies that are tracking the performance of Filtek Supreme universal restorative in a variety of indications that challenge the esthetic and strength capabilities of this nanocomposite. Polymerization Shrinkage The polymerization shrinkage of Filtek Supreme universal restorative was measured in a study conducted at Louisiana State University (LSU), New rleans. LSU uses the AccuVol technique to measure volumetric shrinkage. A wide variety of products were evaluated, with results given below. Filtek Supreme universal restorative displayed very low shrinkage, averaging 2.09%. Figure 21. Volumetric shrinkage (Burgess, J; Xu, X., Xin, X; LSU) l Wear The measurement of wear is critical as an indicator of longevity in posterior restorations. While 3M ESPE uses the three-body wear machine for internal measurements, Creighton University uses a device developed by Leinfelder et al that was designed to simulate both generalized and localized wear. Some feel that localized wear from direct contact is a more important contributor to breakdown than generalized wear as generated by a food bolus during mastication. Composites are placed incrementally into 6mm diameter, 3mm deep cavities in acrylic fixtures. After curing, composites were polished using a sequence of SiC paper and finally a 0.05 micron polishing paste. Samples are held in a cylinder containing a slurry of PMMA beads. A conical stainless steel stylus, mounted on a spring-loaded piston, produces the localized wear. Both volumetric loss and maximum depth were determined using a profilometry technique. Results are presented in Figures 22 and

28 Figure 22. Localized wear: volume loss (Barkmeier, WW; Latta, MA) Figure 23. Localized wear: maximum depth (Barkmeier, WW; Latta, MA) Clinical Studies Katholieke Universiteit Leuven, Belgium In this 5 year study, 3M ESPE Filtek Supreme Universal Restorative is being compared to 3M ESPE Z100 Restorative and enamel for occlusal contact wear in class I and II restorations. Previous studies at this university has shown Z100 Restorative wearing equivalent to enamel in occlusal contact areas through 4 years of clinical service. Eighteen restorations of each material were placed, using a split mouth model, in upper or lower molars. 3M ESPE Adper Single Bond adhesive was used as bonding agent for both materials. Gypsum replicas were made at baseline, six and 12 months for laser scanning contact areas for composite and enamel wear. Epoxy replicas were used for SEM analysis. At each recall, restorations were evaluated per USPHS criteria for posterior restorations. Results through one year: Mean vertical CA wear (microns) Material/Time Z100 Filtek Supreme Enamel 6m -50 (SD-19) (n-30) -48 (SD-17) (n=35) -46 (SD-24) (n-115) 12m -59 (SD-20) (n-40) -64 (SD-31) (n-52) -58 (SD-19) (n-144) The mean occlusal vertical and volumetric loss were equivalent for all materials at each recall. After one year, the polish of Filtek Supreme Universal restorative was significantly better than Z100 Restorative. 28

29 Manitoba University Dental School - Winnipeg, Canada 3M ESPE Filtek Supreme Universal Restorative is being evaluated in Class I and II restorations over three years. 60 restorations were placed in adult patients with 75% of these representing a Class II preparation design. Several large, multi-surface restorations were included per ADA study design parameters. All restorations were bonded using Adper Single Bond Adhesive manufactured by 3M ESPE. Restorations were evaluated at baseline, six months, one and two years by two calibrated examiners. Replica models were evaluated for wear using ML scale. Percent Alpha Baseline 6 Months ne Year Two Year Margin Discoloration Margin Integrity Color Match Anatomic Form Surface Texture Secondary Caries Post-operative Sensitivity Contact Wear Recall Rate All restorations were judged clinically acceptable at all recalls (criteria rated either alpha or bravo). After 2 years of service, generalized wear was measured at 36 microns. The evaluators noted a high degree of polishability was achieved with Filtek Supreme universal restorative and that after two years the surface texture remained smooth and shiny. It was concluded that, the clinical performance of Supreme placed in the posterior dentition continued to be excellent at 2 years. Johannes Gutenberg-University Mainz, Germany Filtek Supreme universal composite (FS) is being evaluated in Class II, stress bearing restorations together with Tetric Ceram (TC) in a split mouth design. 112 restorations were placed in 50 patients using Adper Single Bond adhesive as the bonding agent for both materials. After two years the restorations were recalled and evaluated according to Ryge/CDA Criteria. scar Alpha Bravo Charlie Delta FS TC FS TC FS TC FS TC FS TC Margin Adaptation Anatomic Form Secondary Caries Margin Discoloration Surface Texture Color Match Two Year Results No significant differences were noted between the two materials evaluated at the two year recall. Filtek Supreme universal restorative was judged efficacious for clinical use including placement in larger stress bearing posterior restorations. 29

30 Loma Linda University Loma Linda, California The clinical performance of 3M ESPE Filtek Supreme Universal Restorative is being studied in anterior restorations encompassing Class IV and V restorations, diastema closures, incisal edge repair and facial veneers. 44 restorations were placed in maxillary incisors and canines in 28 patients. At the two year recall, 37 restorations were evaluated using a modified USPHS grading criteria. 2 year recall results Alpha Bravo Charlie Delta BL / 2Yr BL / 2Yr BL /2 Yr BL /2 Yr Margin Adaptation 98/97 2/3 0/0 0/0 Anatomic Form 100/97 0/3 0/0 0/0 Color Match 80/ 78 18/14 2/8 0/0 Secondary Caries 100/ 100 0/0 0/0 0/0 Margin Discoloration 100/95 0/5 0/0 0/0 Polishability 100/97 0/3 0/0 0/0 It was reported that the overall clinical performance of Filtek Supreme universal restorative is acceptable for routine clinical use. The results of this study are significant in that the design challenges the esthetic capabilities of Filtek Supreme universal restorative in various anterior indications as well its strength capabilities in incisal edge repair and Class IV restorations. 30

31 Technique Guides Direct Composite Restorative Anterior Restorations-Simple Filtek Supreme XT Universal Restorative Adper Adhesive Systems Sof-Lex Discs and Strips

32 Direct Composite Restorative Anterior Restorations- Multi-Shade Filtek Supreme XT Universal Restorative Adper Adhesive Systems Sof-Lex Discs and Strips 1 Dentin 2 Body 3 Enamel and/or Translucent M ESPE

33 Direct Composite Restorative Posterior Restorations-Simple Filtek Supreme XT Universal Restorative Vitrebond Light-Cure Glass Ionomer Liner/Bass Adper Adhesive Systems Sof-Lex Discs, Strips and Finishing Brush 1 Body

34 Direct Composite Restorative Posterior Restorations- Multi-Shade Filtek Supreme XT Universal Restorative Vitrebond Light-Cure Glass Ionomer Liner/Bass Adper Adhesive Systems Sof-Lex Discs, Strips and Finishing Brush 1 Dentin (or Body) 2 Body (or Dentin) 3 Enamel and/or Translucent M ESPE