Filtek™ LS Low Shrink Posterior Restorative

LS System Adhesive Self-Etch Primer & Bond

Technical Product Profile

Table of Contents

Table of Contents Introduction................................................................................................................ 1 History.............................................................................................................................. 1 Rationale.......................................................................................................................... 3 Overview of Materials............................................................................................ 4 Filtek™ LS Low Shrink Posterior Restorative................................................................. 4 Chemistry of Resin System......................................................................................... 4 Ring-Opening Polymerization.................................................................................... 5 Initiator System........................................................................................................... 6 Filler Technology........................................................................................................ 6 LS System Adhesive Self-Etch Primer and Bond............................................................. 7 Chemical Background................................................................................................. 7 LS System Adhesive Self-Etch Primer....................................................................... 8 LS System Adhesive Bond.......................................................................................... 9 Test Results................................................................................................................ 10 Polymerization Shrinkage.............................................................................................. 10 Polymerization Stress..................................................................................................... 12 Cusp Displacement........................................................................................................ 15 Adhesion......................................................................................................................... 16 Marginal Quality of the Restoration.............................................................................. 17 Wear............................................................................................................................... 18 Flexural Fatigue Limit................................................................................................... 18 Compressive Strength and Flexural Strength................................................................ 19 Flexural Modulus........................................................................................................... 19 Fracture Toughness (KIC).............................................................................................. 20 Depth of Cure................................................................................................................. 20 Ambient Light Stability.................................................................................................. 21 Water Sorption and Exogenic Staining.......................................................................... 22 Clinical Studies ............................................................................................................. 22 3M ESPE Application Test..................................................................................... 23 CLINICAL CASE ............................................................................................................. 24 Clinical Application of the Filtek™ LS System.............................................................. 24 Technique Guide ...................................................................................................... 26 Filtek™ LS Low Shrink Posterior Restorative............................................................... 26 LS System Adhesive Self-Etch Primer and Bond........................................................... 26 Indications............................................................................................... 27 Shades............................................................................................................................ 27 Composition................................................................................................................ 27 Questions and Answers....................................................................................... 28 Summary........................................................................................................................ 33 Literature.................................................................................................................... 34 Technical Data........................................................................................................... 36

INTRODUCTION

Introduction Filtek™ LS Low Shrink Posterior Restorative and LS System Adhesive Self-Etch Primer and Bond is a complete system for Class I and II direct posterior restorations. Filtek LS restorative is offered in 4 radiopaque shades (A2, A3, B2, C2) with one opacity. This restorative is based on a new resin chemistry – silorane technology – which has achieved the lowest shrinkage currently available. The reduced shrinkage leads to greatly reduced polymerization stress. Filtek LS Posterior Restorative is used with LS System Adhesive. The dedicated adhesive is an advanced self-etching formulation delivered in vials. The formulation of LS System Adhesive specifically fits the chemistry of the Filtek LS restorative. The specially-adapted LS adhesive and the reduced shrinkage of the Filtek LS composite lead to restorations with excellent marginal integrity.

History Composite materials have been used in dental practices to restore teeth since 3M first introduced a composite to the dental market in 1964. Composites consist of fillers embedded in a chemically-reactive organic resin matrix. Fillers are typically inorganic materials like glass or quartz which are generally functionalized on the surface (silanization), enabling chemical linkage to the resin matrix. The early materials were chemically-cured, two-component systems. These tooth-colored materials provided better esthetics than amalgam. However, much had to be learned about the chemical and physical properties that were required to withstand the aggressive oral environment. High shrinkage, high wear, color changes and lack of bonding to tooth surfaces were the issues associated with these early materials. 1901

Synthesis and polymerization of methyl methacrylate

1930

Use of PMMA as denture base resin (Germany)

1944

First acrylic filling material

1951

Addition of inorganic fillers (non-bonded) to direct filling materials (Knock and Glenn)

1955

Investigation of epoxy resins as direct filling materials

1955

Acid-etch technique introduced (Buonocore)

1958

Dimethacrylates (Bis-GMA) and silanized inorganic filler investigated as direct filling material (Bowen)

1964

Bis-GMA composites marketed

1968

Development of polymeric coatings on fillers (Dental Fillings Ltd)

1973

UV-cured dimethacrylate composite resins

1977

Visible light-cured dimethacrylate composite resins

2007

Introduction of Filtek™ LS System to the market

Table 1: History of major developments in composite resins (From 1901 – 2007)

Significant improvements have been made since then (Table 1). On the one hand, adhesive systems have been developed that adhere well not only to enamel, but even to moist dentin. On the other hand, composites have been made stronger, with higher wear resistance and color stability. And, both composites and adhesives have been modified to be curable on demand by exposure to light.

1

INTRODUCTION Improvements on the composite side were achieved, to a great extent, by optimizing the fillers – while the chemistry behind the organic resin matrix remained essentially the same since the pioneering work of R. L. Bowen in the 1960s. Practically all composites employ dimethacrylates such as TEGDMA, Bis-GMA or UDMA, which are radically polymerized as the primary resin (Fig. 1). Figure 1: Methacrylate resin chemistry

O O

O

O

O

O

TEGDMA O

O

O

O

O

H N

N H

O

O

O UDMA O

OH O

O

O

O OH

O Bis-GMA

It is striking, that during these decades of improvement, polymerization shrinkage was only incrementally reduced to a somewhat lower level. Reducing the polymerization shrinkage of composite materials without compromising physical and handling properties remained the major challenge for material scientists. Shrinkage is one of the major drawbacks of composite materials. Shrinkage results in a built-in polymerization stress which challenges the tooth/composite interface. To achieve long-term marginal integrity of restorations, technically-perfect bonding to enamel and dentin with high bond strength is necessary to counteract the shrinkage and polymerization stress. Polymerization shrinkage is an intrinsic property of the resin matrix. Upon curing, the single resin molecules move towards each other and are linked by chemical bonds to form a polymer network. This reaction leads to a significant volume contraction.

Source: 3M ESPE internal data

Shrinkage (vol %)

Figure 2: Simulated dependency of the volumetric shrinkage of composites on the filler content in weight percent plotted for typical methacrylate-based resins and the silorane resin

To date, the main strategy to reduce shrinkage focused on increasing the filler load, thereby reducing the proportion of the methacrylate resin (Fig. 2). Since the shrinkage is caused by the resin, the lower the proportion 4 of resin in a composite, the lower the 3,5 Silorane shrinkage will be. However, the 3 Methacrylate shrinkage intrinsic to the methacrylate 2,5 resin has remained a major challenge. 2 Therefore, exchanging the resin seems 1,5 the most promising pathway to solve 1 the shrinkage problem. 0,5 0 60

2

65

70

75 80 85 90 Filler Content (wt %)

95

100

INTRODUCTION It’s time to face the next challenge: the fundamental improvement of the resin matrix by advancing beyond the current methacrylate resin systems. Filtek™ LS Low Shrink Posterior Restorative resin is based on silorane chemistry and does not contain methacrylates. The silorane ring-opening monomers provide for low polymerization shrinkage. The new silorane platform provides a fundamental solution to the long-standing customer need for low shrinkage.

Rationale Polymerization shrinkage and the resulting shrinkage stress, lead to microleakage which is among the major factors for composite material failures in the oral environment. Moreover, shrinkage stress can lead to tooth deformation, enamel cracks and stress-induced post-operative sensitivity (Fig. 3). Materials which remain dimensionally stable upon polymerization, coupled with an advanced bonding to the enamel and dentin, will markedly enhance the stability of the restoration under functional stress. Filtek LS Low Shrink Posterior Restorative is designed to minimize shrinkage and polymerization stress.

Figure 3: Clinical challenges associated with high shrinkage and polymerization stress

3

Overview OF MATERIALS

Overview of Materials Filtek™ LS Low Shrink Posterior Restorative Chemistry of the Resin System The development of dental restorative composites began in the late 1940s. Since then many technological developments have significantly improved the clinical performance of dental resin composites. However, the common chemical basis for all restorative composites remained the radical polymerization of methacrylates or acrylates. The low-shrinking Filtek LS restorative is based on the new ring-opening silorane chemistry.

Siloranes are a totally new class of compounds for the use in dentistry. The name silorane derives from its chemical building blocks siloxanes and oxiranes (Fig. 4). Figure 4: Silorane chemistry

Siloxanes are well known in industrial applications for their distinct hydrophobicity. By incorporating the siloxanes into the dental silorane resin, this property was transferred to the Filtek LS composite. Oxiranes have been used for a very long time in many technical fields, especially where high forces and a challenging physical environment are expected, such as in the manufacture of sports equipment like tennis rackets or skis, or in the automotive and aviation industries and many more. The oxirane polymers are known for their low shrinkage and the outstanding stability toward many physical and chemophysical forces and influences.

Figure 5: Composition of Filtek™ LS Low Shrink Posterior Restorative

4

The combination of the two chemical building blocks of siloxanes and oxiranes provides the biocompatible, hydrophobic and low-shrinking silorane base of Filtek LS Low Shrink Posterior Restorative. This innovative Stabilizer 0.13% resin matrix represents the major Initiator 0.9% Pigments 0.005% difference of Filtek LS restorative compared to conventional methacrylates. Also, the initiating Silorane resin 23% system and the filler were adapted in order to provide the best performance of the new technology (Fig. 5).

Filler 76%

Overview OF MATERIALS Ring-Opening Polymerization The polymerization process of Filtek LS restorative occurs via a cationic ring-opening reaction which results in a lower polymerization contraction, compared to the methacrylate-based resins which polymerize via a radical addition reaction of their double bonds. The ring-opening step in the polymerization of the silorane resin significantly reduces the amount of polymerization shrinkage which occurs in the curing process. The reduced amount of shrinkage is illustrated schematically in Fig. 6. During the polymerization process, molecules have to approach their “neighbors” to form chemical bonds. This process results in a loss of volume, namely polymerization shrinkage. In contrast to the linear-reactive groups of methacrylates, the ring-opening chemistry of the siloranes starts with the cleavage and opening of the ring systems. This process gains space and counteracts the loss of volume which occurs in the subsequent step, when the chemical bonds are formed. In total, the ring-opening polymerization process yields a reduced volumetric shrinkage. Figure 6: Reactive sites of silorane and methacrylates and corresponding shrinkage reduction upon polymerization 1

 1% volumetric shrinkage tested < by bonded disc method

Besides shrinkage, another parameter of paramount importance to the performance of a restorative material is polymerization stress. Polymerization stress is generated when composites are cured in the bonded state and the polymerization shrinkage develops forces within the cavity walls. The rigid tooth structure will withstand this force to a certain degree, however, these tensions can lead to marginal gaps or to damage of healthy tooth structure by its deformation. These forces or tensions are summarized under the term “polymerization stress.” From the restorative material perspective, polymerization stress is mainly determined by three factors: 1) the polymerization shrinkage, 2) the internal flowability of the material, and 3) the polymerization kinetics (polymerization speed). A highly-shrinking material with a small, internal flowability and very fast curing speed in the first few seconds, will exhibit the highest polymerization stress. Silorane technology was developed to minimize shrinkage, and is thus also predestined for low stress development. Moreover, the kinetics of the initiation and polymerization of the Filtek LS resin were optimized to provide very low polymerization stress, as will be shown in the Test Result chapter. 5

Overview OF MATERIALS Initiator System One component of the initiating system is camphorquinone, which matches the light spectrum of conventional dental polymerization light sources. 3M™ ESPE™ Filtek™ LS Low Shrink Posterior Restorative can be cured with halogen, as well as LED devices. Further components of the initiating system are iodonium salts and electron donors, which generate the reactive cationic species that start the ring-opening polymerization process (Fig. 7). Figure 7: Initiation chemistry for silorane Electron Donor

I

A

O Camphorquinone

Initiatior: reactive cationic species

+

O

Iodonium salt

The initiating system of Filtek LS restorative was tailored so that the resulting polymerization kinetics leads to a minimized polymerization stress. A unique property of the three-component initiating system is that a “critical mass” of initiating reactive cationic species has to be generated to start the polymerization. This threshold behavior brings one major advantage: it allows the practitioner to work longer under full operatory light than with any conventional methacrylate-based composite. While developing low stress and being stable against ambient light, the curing times for 2.5 mm increments of Filtek LS restorative could be kept at a level comparable to conventional composites: Halogen light devices

Exposure time

Wave length spectrum 400-500 nm Output 500–1400 mW/cm2,

40 sec, standard mode

LED light devices

Exposure time

Wave length spectrum 430-480 nm Output 500-1000 mW/cm2, Output 1000-1500 mW/cm2, (e.g., Elipar™ FreeLight 2, manufactured by 3M ESPE)

40 sec, standard mode 20 sec, standard mode

However, the threshold behavior of the Filtek LS restorative initiator system requires a minimum curing time of 20 seconds, which can not be compensated by higher intensities. Very high intensity light sources like plasma arc lamps and lasers do not allow sufficiently-long curing times due to heating of the tooth. Therefore, plasma arc lamps, lasers and other light sources with very high intensities are contraindicated to be used with Filtek LS restorative.

Source: 3M ESPE internal data

6

6 5 Volume (%)

Figure 8: Filler-size distribution of Filtek™ LS Low Shrink Posterior Restorative

Filler Technology Filtek LS restorative is filled with a combination of fine quartz particles and radiopaque yttrium fluoride. From the filler side, Filtek LS restorative is to be classified as a microhybrid composite. The quartz surface is modified with a silane layer which was specifically matched to the silorane technology in order to provide the proper interface of the filler to the resin for long-term, excellent mechanical properties (Fig. 8).

4 3 2 1 0 0.01

0.1

1

10

100

Quartz Particle Size (µm)

1000

Overview OF MATERIALS

LS System Adhesive Chemical Background Recently, self-etch adhesives have gained increasing popularity among dentists. Their success is mainly based on their ease of use, low technique sensitivity and ability to reduce post-operative sensitivity as compared to total-etch adhesives. LS System Adhesive Self-Etch Primer and Bond is a new member of the 3M ESPE family of successful self-etch adhesive materials. LS System Adhesive has been specially designed to provide strong and long-lasting bonding of Filtek LS Low Shrink Posterior Restorative to enamel and dentin, providing the basis for excellent marginal integrity of the restorations. The extraordinary low shrinkage and polymerization stress of Filtek LS restorative have been achieved by developing the new silorane resin system. Curing of this resin system involves chemical mechanisms different from conventional methacrylate-based composites. From a scientific standpoint, it is obvious that a new adhesive is needed. Adhesives currently available on the market have been developed for traditional methacrylate materials and will, therefore, lead to insufficient results in combination with Filtek LS restorative. Due to its siloxane backbone, the silorane resin is more hydrophobic than conventional methacrylate resins, so it results in reduced water uptake and related phenomena, as described in the Test Results section. That means this adhesive has to bridge a larger difference between the hydrophilic tooth substrate and the hydrophobic silorane material as compared to conventional methacrylate materials. Therefore, LS System Adhesive has been designed as a two-step adhesive (Fig. 9): • LS System Adhesive Self-Etch Primer is rather hydrophilic, and ensures strong and durable adhesion to the tooth. • LS System Adhesive Bond is optimized for wetting and adhering to the hydrophobic Filtek LS Posterior Restorative.

LS System Adhesive Primer

Hydrophilic

Figure 9: Different regimes of hydrophilicity/ hydrophobicity at the interface between the tooth and Filtek™ LS Low Shrink Posterior Restorative

LS System Adhesive Bond

Hydrophobic Tooth

Filtek™ LS

7

Overview OF MATERIALS LS System Adhesive Self-Etch Primer In principle, self-adhesion is generated by acidic monomers that etch dental substrates and thus create a retention pattern for micromechanical interlocking of the cured adhesive with the tooth. Furthermore, they provide chemical bonding to the calcium-containing hydroxyapatite of the mineralized tissue. Most of today’s self-etch adhesives contain phosphorylated methacrylates as acidic monomers; some contain carboxylic acid functionalized monomers, or a combination of both. LS System Adhesive Self-Etch Primer contains phosphorylated methacrylates, as well as the Vitrebond™ copolymer with its carboxylic acid functionality used in many 3M™ ESPE™ resin-modified glass ionomers, and adhesives for adhesion to enamel and dentin. Furthermore, comonomers like BisGMA and HEMA, a solvent system consisting of water and ethanol for wetting and penetrating the dental substrates, and a photoinitiator system based on camphorquinone for thorough and fast curing are included. A silane-treated silica filler with a primary particle size of about 7 nm has been added for improving the mechanical strength and film-forming properties of LS System Adhesive Self-Etch Primer. This filler is very finely dispersed in order to prevent settling. Special attention has been devoted to providing a stable formulation that combines acidic monomers and the water/ethanol solvent system. Refrigeration is required in order to prevent loss of ethanol or water by evaporation. With a pH of about 2.7, LS System Adhesive Self-Etch Primer provides rather mild etching and demineralization of the tooth structure, yet strong and durable bonding through its nanoetching pattern, as well as chemical bonding to the hydroxyapatite. If LS System Adhesive is to be applied to uncut enamel, a separate etching of the unprepared tooth structure is recommended. It is not required to etch prepared enamel but it may be done if desirable. On dentin, well-defined resin tags are visible and penetration of the dentin structure by LS System Adhesive Self-Etch Primer (Fig. 10). Figure 10: SEM micrograph of the composite/adhesive/ dentin interface after consecutive etching with hydrochloric acid and sodium hypochlorite solution Source:

8

3M ESPE internal data

Overview OF MATERIALS LS System Adhesive Bond LS System Adhesive Bond is also based on methacrylate chemistry. As a main component, it contains a unique 3M™ ESPE™ hydrophobic bifunctional monomer in order to match the hydrophobic silorane resin. An immediate result of this feature is the easy adaptation of Filtek™ LS Low Shrink Posterior Restorative on cured LS System Adhesive Bond. Other components include acidic monomers that initiate the ring-opening cationic cure of Filtek LS restorative, thus providing chemical bonding to Filtek LS (Fig. 11). The photoinitiator system is based on camphorquinone. Figure 11: Mechanism of chemical bonding between LS System Adhesive Bond and Filtek™ LS Low Shrink Posterior Restorative

Oxirane Group Acidic Monomer of LS System Adhesive Bond

Curing of Adhesive

Application and Curing of Filtek™ LS Restorative

Chemical Bond Between Adhesive and Composite

LS System Adhesive Bond contains a silane-treated silica filler that not only improves the mechanical strength of the material, but also allows for carefully adjusted viscosity properties. LS System Adhesive Bond may appear very viscous at first glance – you may have to flick it to the tip of the vial in order to dispense it. However, once you apply it with the brush or air-thin it, the viscosity drops by several orders of magnitude (Fig. 12), and it can be very easily dispersed as an even, uniform film. This phenomenon is called shear thinning. The benefits are obvious: it does not drop from the brush; and you can direct it with the air stream where you want it to be and it stays there – especially on the cavity walls and preparation margins – and it does not pool. With LS System Adhesive Bond, the resulting film thickness is in the range of other two-step self-etch adhesives, despite the apparently higher viscosity. 1000

Figure 12: Viscosity of LS System Adhesive Bond at low shear and under application conditions. Application and air thinning reduces the viscosity by several orders of magnitude, thus allowing for formation of an even and homogeneous film

Viscosity At Rest

Viscosity (Pa•s)

100

10

Viscosity At Application/ Air Thinning

1

Source:

3M ESPE internal data

0.1 0.001

0.01

0.1

1

10

100

1000

10000

Shear Rate (1/s)

9

TEST RESULTS

Test Results Filtek™ LS Low Shrink Posterior Restorative has been tested extensively, both in-house as well as at renowned universities worldwide – and many results have been published in peer-reviewed journals. In this evaluation care was taken to address the most important quality parameters for composite restorations.

Polymerization Shrinkage Polymerization shrinkage is still a major concern. Prof. Swift and co-workers stated only recently that “although composites are now the material of choice for most restorations, their polymerization shrinkage remains a problem. The contraction stress associated with this shrinkage can cause debonding at the composite/tooth interface and can contribute to post-operative sensitivities, enamel fracture, recurrent caries marginal staining and eventually failure of the restoration.” (Yamazaki, Bedran, Russo, Pereira and Swift, 2006) Filtek LS restorative has been developed to minimize polymerization shrinkage and polymerization stress, while providing a high-performance bond to the tooth. Extensive testing of polymerization shrinkage has been conducted which shows Filtek LS restorative to have a significantly lower shrinkage than all methacrylate composites tested, irrespective of the method employed (Fig. 13, Fig. 14, Fig. 15). Most common measurements for polymerization shrinkage are the bonded-disc method, also referred to as Watts method (Watts & Cash 1991), and the Archimedes method which was recently developed into a German Standard (DIN 13907/2005). The bonded-disc method results in lower shrinkage values since only the linear shrinkage of a bonded composite disc is measured and then converted into % of volume. Whereas the Archimedes method measures the actual shrinkage in volume according to the buoyant force principle. However, both methods show a high correlation (Weinmann et al., 2005). The bonded-disc method revealed shrinkage values for Filtek LS restorative of 0.9 % (Fig. 13), while the polymerization shrinkage is about 1% when measured with the Archimedes method (Fig. 14).

Source:

3M ESPE internal data

3 2.5 Shrinkage (%)

Figure 13: Polymerization shrinkage (bonded-disc method) of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composites

2 1.5 1

10

H®

TP H® 3 Fil tek ™ LS

TP

us ™ Ve n

um ®

ctr Sp e

ram Es the tX ®

me Tet r

ic ®

pre Su

tek ™

Fil

Ce

o

S

Du

EL

X™

AP X

dio ®

iXX ™ tek ™ P6 0 Fil tek ™ Z2 50 Fil

Qu

il ®

Cle arf

Gr an

LS

il ™ aF

lite ™

Ae

m® era

Xtr

Ce ram

Tet r

ic

Ev oC

Pre mi

0

se ™

0.5

TEST RESULTS

4

Figure 14: Polymerization shrinkage (Archimedes method) of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composites

3.5

Shrinkage (%)

3 2.5

Source:

2

3M ESPE internal data

1.5 1 0.5

Tet ric

Ev

Pre mi se ™ oC era m® Gr an dio ® Qu iXX ™ Fil tek ™ P Fil tek ™ 60 Z2 50 InT en S ® Fil Aelit tek ™ e ™ Su LS pre me Su reF il ® EL S De Pro fin dig ite ® y® Co Ale nd rt en sa He ble ™ rcu lit Tet e XR V™ ric ® Ce ram Ve nu s™ Es the tX ® Sp T ec tru PH ® m® 3 TP H® So lita ire ® 2 So lita ire ™ Fil tek ™ LS

0

A third method to determine volumetric shrinkage is employing video imaging to determine dimensional changes. The so-called AccuVol method (J. Burgess, U.S.A.) results in a value of 0.66 % volumetric shrinkage for Filtek LS (Fig. 15) and confirms Filtek LS restorative to be the lowest shrinking material among all composites tested. 3.50

Figure 15: Polymerization shrinkage (AccuVol method) of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composite

3.00

2.00

Source:

J. Burgess, U.S.A.

1.50 1.00 0.50

LS tek ™ Fil

4™ int Po

n nti

me l®

De ris ® Mi

na Re

tX ® Es the

Ve nu s™

XR V™

Z1 00 ™

ulit e He rc

Fil ® Su re

Z2 50 tek ™ Fil

lio

mo la

r®

0.00

He

Shrinkage (Vol %)

2.50

11

TEST RESULTS

Polymerization Stress Polymerization stress builds up during polymerization as a consequence of polymerization shrinkage when the gel point is reached, and further contraction cannot be compensated for by additional flow of the material. Filtek™ LS Low Shrink Posterior Restorative develops a very low polymerization stress compared to methacrylate composites, with all methods employed (Fig. 16, Fig. 17, Fig. 18). A wide range of shrinkage-stress data are available for a tensilometer method developed at ACTA (University of Amsterdam). Here a composite sample is luted between a glass and a metal plate. The metal plate is attached to a load cell. While the composite is cured through the glass plate, the height of the composite sample is held constant by the testing device. The force needed to keep the height constant is recorded.

Figure 16: Polymerization stress (Tensilometer method) of Filtek™ LS Low Shrink Posterior Restorative compared to several methacrylate composites

18 16 14

Stress (MPa)

12

Source: Dr. DeGee and Prof. Feilzer, University of Amsterdam (ACTA)

10 8 6 4 2 0 0

300

600

1200

900

1500

1800

Time (sec) QuiXX™

Spectrum® TPH®

Tetric® Ceram

Filtek™ Z250

Filtek™ Supreme

Filtek™ LS

8 7 6 5 4 3 2

LS tek ™ Fil

Ve nu s™

TP

H® 3

tX ® the

tru m®

Es

ec Sp

mX ™ Ce ra

m®

lite ™ rcu He

era

Ev oC

en tin e-d

P6 0 se ™ mi Pre

e

dio ® an

tek ™ Fil

Gr

rem

LS

Su p

oE Fil

tek ™

il ™

mc

aF

Sa re

tel Es

12

Xtr

0

Qu iXX ™

1

ite ®

Source: Prof. Watts, University of Manchester

9

Sig ma

Figure 17: Polymerization stress (Bioman method) of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composites

Polymerization Stress (MPa)

Watts et al. (2003) developed a method to determine the photopolymerization shrinkage-stress kinetics in resin composites with the Bioman device. Filtek LS restorative shows significantly lower polymerization stress than the methacrylate composites tested (Fig. 17).

TEST RESULTS Another method for the evaluation of shrinkage stress was performed by Prof. Ernst (University of Mainz) by means of a photoelastic investigation. Composite specimens were bonded in Araldit plates and cured with a halogen curing light. The strain forces induced by the polymerization shrinkage of the composites into the Araldit plate can be visualized as isochromatic rings in a polarizing microscope. The polymerization stress was calculated from the diameter of the first order isochromatic rings, at 4 minutes and again at 24 hours after exposure. The results reveal that Filtek LS restorative generated the lowest polymerization stress among all composites tested (Fig. 18). Additionally, all methacrylate-based materials continued to build up stress: the values measured after 24 hours are always higher than after 5 minutes. Filtek LS restorative was the only material which maintained the same low-stress value observed after 5 minutes and did not continue to build up stress (Ernst et al. 2004).

6 t=4 min t=24 hr

4

Source: Prof. Ernst, University of Mainz

3

2

LS tek ™ Fil

-S ® InT en

2 re ® lita So

rio ste Po oto

Cle

arf

il ®

Ph

Co y® dig Pro

r

il ®

0 P6

reF Su

en nd

tek ™

sa

AP il ® arf Cle

Fil

ble ™

-X

50 Z2 tek ™ Fil

the Es

ic ®

Ce

ram

0

tX ®

1

Te tr

Polymerization Stress (MPa)

5

Figure 18: Polymerization stress determined by photoelastic investigations

13

TEST RESULTS The low stress development of Filtek™ LS Low Shrink Posterior Restorative can be visualized by Finite Element Analysis. Dr. Versluis (University of Minnesota) simulated the spatial distribution and the intensity of polymerization stress compared to a low-shrink methacrylate (Fig. 19). Note that the Filtek LS restoration shows an absence of “gray” high-stress areas where enamel cracks and leakage in the margin can occur.

Figure 19: Finite Element Analysis of Polymerization Stress

Most stress MPa

Source: Dr. Versluis, University of Minnesota

Restoration: Filtek™ LS

50

0 Least stress

Restoration: QuiXfil™

The correlation between polymerization shrinkage and polymerization stress can be seen in Fig. 20, which shows the unique position of Filtek LS restorative made possible through silorane technology.

Source: Prof. Watts, University of Manchester

9

Venus™

8

EsthetX® 7

EvoCeram

®

6 Stress (MPa)

Figure 20: Correlation between polymerization shrinkage and polymerization stress of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composites (Shrinkage method: Bonded disc method; Stress method: Bioman)

Premise™

ELS

5

XtraFil™

4

TPH®3

CeramX™ Herculite XRV™ Filtek™ P60 Grandio® QuiXX™

Estelite® 3 2

Filtek™ LS 1 0

0

0.5

1

1.5 Shrinkage (%)

14

2

2.5

3

TEST RESULTS

Cusp Displacement A clinical implication of high polymerization stress and polymerization shrinkage is cusp displacement, which can result in the damage of healthy tooth structure (e.g., enamel cracks) and strain-induced hypersensitivities. Prof. Bouillaguet (University of Geneva) showed that Filtek LS Low Shrink Posterior Restorative generates a much lower cusp displacement compared to methacrylate-based composites (Bouillaguet et al. 2006, Fig. 21).

8

7

Cusp Displacement (microns)

6

5

4

3

2

1

0 0

50

100

150

200

Time (sec) Premise™

Tetric® Flow

Tetric® Ceram

QuiXX™

Filtek™ LS

Figure 21: Time resolved cusp displacement of teeth with Filtek™ LS and methacrylate composites placed in Class II MOD cavities. [Electronic speckle pattern interferometry (ESPI)] Source: Prof. Bouillaguet, University of Geneva

15

TEST RESULTS

Adhesion Adhesion with sufficient high-bond strength is a key factor determining the seal of a filling and the stabilization of the restored tooth. To ensure optimal linkage of Filtek™ LS Low Shrink Posterior Restorative to the tooth, a dedicated LS System Adhesive has been developed. Bond strength of the LS System Adhesive in combination with Filtek LS restorative was evaluated with the widely-used tensile bond test where load is applied perpendicular to the tooth surface, and shear bond testing where load is applied parallel to the tooth surface. Prof. Powers (University of Michigan) determined tensile bond strengths to enamel and dentin for the Filtek LS System to be higher than a variety of clinically successful bonding systems (Fig. 22). Cut Enamel 30

Source: Prof. Powers, University of Michigan

20

Dentin

(MPa)

Figure 22: Tensile bond strength of the Filtek™ LS System and methacrylate systems

3M ESPE internal data

ste Sy

Qu

LS

III/ Fil

tek ™

no ® Xe

no ® Xe

Fu

tur

ab

m

iXX ™

X™ ram III/

R/ dN on

tric SE ® /Te

he

35

Op

10

Ce

an Gr

oC Ev

NT ™ /Es Ad

d® on

dio ®

m® era

tX ® the

RV ™ eX ulit &B me Pri

-In on tib

Op

15

d®

tib

All

on

Cle

d®

arf

20

-O

All

ne

-In

/H

-O

erc

ne

lea /C SE

il ®

25

rfil ®

30

/Pr em

AP

X

ise ™

0

5 Dentinstrength Enamel Similarly, shear bond of LS System 0 Adhesive revealed bond strength values Tetric EvoCeram/ similar to or better than current adhesive AdheSE systems (Fig. 23).

30

Enamel

25

Dentin

Dentin

Enamel

20

Filtek Silorane/ Silorane Adhesive

15 10 5

il ®

SE /AP X

0

Pro Filte mp k ™ Sp t ™ Z25 ec L-P 0/ tru m® op ™ TP H® /Xe no ® III Ve nu s™ /iB on d™ Fil tek ™ LS Sy ste m

Source:

35

Shear Bond Strength (MPa)

Figure 23: Shear bond strength of the Filtek™ LS System and methacrylate systems

Shear Bond Strength After TC (MPa)

10

Source: Prof. Fischer, University of Zurich

r™ pe

25 20 15 10 5 Dentin Enamel 0

16

arf Cle

30

Ad

Figure 24: Bond strength after thermocycling of Filtek™ LS System as compared to a leading methacrylate system

Shear Bond Strength after TC (MPa)

35

Tetric EvoCeram®/ AdheSE®

Dentin

Enamel

Filtek™ LS/ LS Adhesive

Prof. Fischer (University of Zurich) investigated the durability of the adhesive interface by thermocycling and subsequent determination of shear bond strength. Filtek LS System showed a significantly higher bond strength after thermocycling compared to a leading methacrylate system (Fig. 24).

TEST RESULTS

Marginal Quality of the Restoration Due to the low shrinkage and low polymerization stress of the Filtek LS Restorative System, a smaller portion of the bond strength has to be invested to counteract forces resulting from shrinkage. Thus, more effective bond strength remains to counteract mastication forces and forces resulting from temperature changes. The low polymerization shrinkage of Filtek LS restorative, in combination with the excellent bond strength, leads to excellent marginal integrity of the restoration (Fig. 25).

Bond strength

Bond strength

Polymerization stress

Polymerization stress

Conventional composite: adhesive and shrinkage forces work in strong opposition.

Figure 25: Bond strength and polymerization stress act in opposite directions

The Filtek™ LS System ensures marginal quality due to reduced shrinkage forces combined with excellent adhesive force values.

% Continuous Margin (Enamel and Dentin)

Filtek LS Restorations were challenged in a chewing-simulation test device which combined 450,000 cycles of loading with 50 N per load and thermocycling for 1,550 cycles between 5°C and 55°C. The results showed that Filtek LS System provides better marginal integrity before and after chewing simulation, as compared to leading methacrylate systems (Fig. 26).

100

Figure 26: Marginal integrity of the Filtek™ LS System as compared to leading methacrylate systems

80 60

Source: 3M ESPE internal data

40 20 0

Before Chewing

After Chewing

Tetric EvoCeram®/ AdheSE®

Before Chewing

After Chewing

QuiXX™/ Xeno® III

Before Chewing

After Chewing

Filtek™ LS/ LS System Adhesive

17

TEST RESULTS

Wear The wear rate of Filtek™ LS Low Shrink Posterior Restorative was determined in a three-body abrasion test according to the ACTA method. In this test, a sample wheel filled with composites (Body 1) is rotated against a structured stainless steel wheel (Body 2) in a millet suspension (Body 3). As the stainless steel wheel is narrower than the sample wheel, it leaves an abrasion mark on the samples, the depth of which can be determined by means of a profilometer. The deeper the abrasion mark, the less resistant the material is to wear. The three-body wear of Filtek LS restorative corresponds to that of the clinically-tried and proven composites (Fig. 27).

2 1.5 1 .5

pre

me

m®

Su

era oC Ev ic

Tet r

Gr

ad

ia ®

Dir ec

t

tX ® the

X™ ram

Es

Du

o

S EL

Ce

ram ic ®

Ce

LS Tet r

tek ™ Fil

4™ int Po

sm ari Ch

Fil

tek ™

Z2

50

a®

0

tek ™

3M ESPE internal data

2.5

Fil

Source:

3

Abrasion Relative to Z250

Figure 27: Three-body wear for Filtek™ LS Low Shrink Posterior Restorative and methacrylate composite

Flexural Fatigue Limit Restoration fracture due to material fatigue is one of the main reasons for failure of direct restorations. To obtain insight into the fatigue behavior of the Filtek LS restorative its flexural fatigue limit was determined and compared with conventional methacrylate composites. In this test 10,000 cycles of 3-point loading were applied with the frequency of 2 Hz, which is the upper limit of chewing frequency, under wet conditions and a constant temperature of 35°C. Several tests were done for each material, increasing the stress compared to the previous test if a material did not fail, and decreasing the stress if the material broke under loading. This procedure is referred to as the staircase approach. The flexural fatigue limit of Filtek LS restorative under wet conditions reaches top level, indicating a long-term durability of Filtek LS restorative under clinical conditions (Fig. 28).

Source: Prof. Braem, University of Antwerp

90 80 Shear Flexural Fatigue Limit (MPa)

Figure 28: Flexural fatigue limit of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composites

70 60 50 40 30 20 10 0

18

Charisma®

Tetric® Ceram

Filtek™ Z250

SureFil®

Solitaire® 2 Prodigy® Condensable®

Filtek™ LS

TEST RESULTS

Compressive Strength and Flexural Strength A high compressive strength and a high flexural strength of the restoration material protects from fractures and stabilizes the tooth at the same time, especially when used in posterior restorations. The compressive strength of Filtek LS restorative was determinded by increasing the load on specimens of 3x3x5 mm until fracture. Flexural strength was determined using the a three-point bending test. In this test the material is fixed at two points and stress is applied to a third point until fracture. During the test, compressive forces built up on the upper side and tensile forces at the lower side. Both the compressive strength and flexural strength of Filtek LS restorative rank within the range of clinically proven composites and are substantially above the ISO 4049 limit of 80 MPa (flexural strength) (Fig. 29). 500 450

Compressive Strength

400

Flexural Strength

Figure 29: Compressive strength and flexural strength of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composites

350 (MPa)

300

Source:

3M ESPE internal data

250 200 150 100

Tet r

se ™ mi

me

Fil

Pre

pre

tek ™

Su

Ve n

us ™

LS tek ™

H® 3

Fil

TP

tX ® the

dio ®

Es

an Gr

mo lio

era

He

oC ic

Ev

lar ®

m®

o Du

S

X™

EL ram

Ae

lite ™

Ce

LS

Pa

Qu

ck

Gla

ab

cie

r

le

0

iXX ™

50

Flexural Modulus The flexural modulus defines the rigidity of a material and is determined on the basis of the same experimental set-up as flexural strength. There are no standard values indicating how high the flexural modulus of a restoration material should be. If the flexural modulus is too high, the material is more brittle and filling fractures are more likely. If the flexural modulus is too low, the tooth would not be provided with adequate stability. The flexural modulus of Filtek LS restorative ranks within the range of clinically-proven composites (Fig. 30). Figure 30: Flexural modulus of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composites

20000 15000

Source:

3M ESPE internal data

10000

EL S

ite ®

Sig

ma

a® Es

tel

Ch ari sm

Ve nu s™

LS

TP H® Ce 3 ram X™ Tet Du ric o Ev oC era m®

tX ®

k™

Fil te

50 Z2

Es the

XR V™

k™

Fil te

ulit e

He rc

Fil

tek ™

P6 0

dio ® an Gr

™

iXX Qu

e™

0

LS

5000

Ae lit

Flexural Modulus (MPa)

25000

19

TEST RESULTS

Fracture Toughness (KIC) Fracture toughness is a measure of the resistance of a material to crack formation. A notch is sawed into rod-shaped test bodies, which are then pulled apart with increasing energy until the notch propagates as a crack and the specimen breaks. The fracture toughness of Filtek™ LS Low Shrink Posterior Restorative is in the range of clinically proven methacrylate composites (Fig. 31). 3

Figure 31: Fracture toughness of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composites

2

K1C

Source: Prof. Kunzelmann, University of Munich

2.5

1.5

1

LS tek ™

Qu

Fil

iXX ™

y® dig

lio He

Tet r

Fil

Pro

mo

Ce ic ®

tek ™

Z2

50

ram

0

lar ®

0.5

Depth of Cure The depth of cure was determined by a scratch test in accordance with ISO 4049:1999. For the test, composite cylinders are light cured in a brass mold. After polymerization, the brass mold is removed and the non-polymerized soft composite is scraped off with a spatula. The height of the remaining composite cylinder is measured. On the basis of these measurements Filtek LS restorative may be placed in increments of up to 2.5 mm (Fig. 32). 9

Figure 32: Depth of cure in metal molds according to ISO 4049:1999

8

Dr. Ilie, University of Munich

Depth of Cure (mm)

7

Source:

6 5 4 3 2

20

LS k™ Fil te

mo lar ® He lio

m Ce ra ic ® Tet r

Z2 50 k™ Fil te

Pro d

0

igy ®

1

TEST RESULTS

Ambient Light Stability Ambient light stability contributes to the convenience of handling of a composite material. The ambient light stability of Filtek LS restorative was evaluated according to ISO 4049, which requires stability of a composite to be at least 60 seconds at 8000 Lux illumination (Fig. 33). The silorane technology of Filtek LS restorative offers the dentist up to 9 minutes to place and shape the restoration under operatory light illumination.

Figure 33: Ambient light stability of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composite at 8000 Lux (Method based on ISO 4049)

8

6

Source:

4

3M ESPE internal data

LS tek ™ Fil

H® 3 TP

dio ® an Gr

H® tru ec Sp

se ™

Pa

m®

ck

TP

ab

le

iXX ™ mi

Fil

tek ™

P6

0

50 Z2 tek ™ Fil

the

Qu Pre

Tet r

ic

Ev

oC

era

m®

0

tX ®

2

Es

Ambient Light Stability (min)

10

21

TEST RESULTS

Water Sorption and Exogenic Staining The water sorption of composite restorations leads to swelling and possibly reduction in material properties – and it also facilitates exogenic discoloration. Filtek™ LS Low Shrink Posterior Restorative was compared to methacrylate systems regarding water uptake according to ISO 4049 and its tendency to acquire staining in a coffee-stain test. In the course of this test specimens are immersed in a coffee solution over extended periods of time and the resulting discoloration is expressed as a Delta E-value (Fig. 34). Water sorption for Filtek LS restorative is very low due to the hydrophobicity of the silorane matrix, which results in a very low tendency for exogenic staining.

Source: 3M ESPE internal data

6

Premise™

5

Delta E coffee staining

Figure 34: Water uptake (ISO 4049) and exogenic staining (coffee-stain test) Delta-E values of Filtek™ LS Low Shrink Posterior Restorative and methacrylate composites

Venus™

Grandio

®

4

Tetric EvoCeram®

Estelite® Sigma

3

CeramX™

2

Filtek™ LS 1

0 5

10

15

20

Water uptake (µg/mm3) ISO 4049

Clinical Studies Prof. Ernst, Johannes Gutenberg University of Mainz, Germany Filtek LS restorative is being studied in Class II restorations with an experimental adhesive, together with QuiXfil posterior restorative and Xeno III adhesive, in a split-mouth design. 102 restorations were placed in 46 patients. At baseline and at one year, the restorations were evaluated according to the Ryge/CDA criteria. After one year, all restorations showed clinically excellent and acceptable results. No Charlie or Delta scores were documented (Schattenberg et al. 2007). Prof. Eliasson, University of Iceland In this study the clinical performance of Filtek LS restorative is being tested with an experimental adhesive system, and is compared to Tetric Ceram and a self-etching adhesive, AdheSE. At least one pair of restorations was placed in each patient according to research protocol. At one year, 53 restoration pairs in 31 patients were examined using the modified Ryge/CDA scale. No Charlie and Delta scores were seen. Color match was unchanged. One Tetric Ceram restoration was removed because of sensitivity. At one year, both materials appeared to be clinically acceptable and comparable.

22

3M ESPE APPLICATION TEST

3M ESPE Application Test To evaluate the handling of the Filtek LS system, an in-vivo application test with 43 general practitioners in five European countries was conducted. Dentists were asked to rate several handling criteria of the Filtek™ LS Low Shrink Posterior Restorative. On a 5-point scale, rating 1 stands for an excellent performance and rating 5 for a poor performance (Fig. 35).

Excellent 1

Figure 35: General practitioners rate the handling characteristics of Filtek™ LS Low Shrink Posterior Restorative

2 3

Source:

3M ESPE internal data

4

s tic the Es

ion ap Ad lor Co

Po

lish

ab

tat

ility

ing ish Fin

tab ility ssi ng Op Tim era e U tor nd y-L er igh t

ulp

ce

Sh old To H ility

Sc

ap

e

ility ab ck Pa Ab

Pro

Sti

ck

ine

ss

To I

ns

tru

me

nt

Poor 5

With over 1,100 fillings placed during the 6-week trial period, this application test confirmed the convenient handling of Filtek LS restorative. In a second in vivo application test, 1,145 fillings were placed by 43 general practitioners in Germany. No cases of post-operative sensitivity were reported. 86% stated they were satisfied with the overall handling of the Filtek LS System, and 84% found the system easy to use.

23

Clinical Case

Clinical Case Clinical Application of Filtek LS System ™

The direct restorative filling with the Filtek LS System requires no special technique. It works just like state-of-the-art composite/adhesive systems with one substantial improvement. Due to its greatly reduced sensitivity to ambient light, Filtek™ LS Low Shrink Posterior Restorative can be placed, shaped and modeled under full operatory light illumination for as long as 9 minutes. The case shown is typical: A Class II composite filling had to be replaced due to the occurrence of secondary caries after marginal gap formation.

Initial situation

Shade selection

Prepared cavity with rubber dam, wedge and matrix after removal of old filling and excavation of secondary caries.

Application of LS System Adhesive Self-Etch Primer

Application of LS System Adhesive Self-Etch Primer for 15 seconds with black microbrush, followed by gentle air dispersion and 10 seconds of light curing.

Application of LS System Adhesive Bond

Application of LS System Adhesive Bond with green microbrush, followed by gentle air dispersion and 10 seconds of light curing.

24

Clinical Case

Application of Filtek LS Low Shrink Posterior Restorative

Placement and shaping of Filtek™ LS Low Shrink Posterior Restorative under full operatory light conditions.

20 seconds light curing (Elipar™ FreeLight 2).

Finishing and Polishing (Sof-Lex™).

Final Filtek™ LS Low Shrink Posterior Restorative filling after rehydration of the teeth.

25

Self-Etch Primer and Bond Selbstätzender Primer und Bond

TECHNIQUE GUIDE

Technique Guide

™ ™ ™ Filtek Filtek Silorane Silorane ™ Filtek Silorane ™Posterior Low Shrink Low Low Shrink Posterior Shrink Posterior Restorative Restorative Restorative Filtek Silorane Low Shrink Posterior Restorative ™ NiedrigNiedrig Niedrig schrumpfendes schrumpfendes schrumpfendes Seitenzahn-Füllungsmaterial Seitenzahn-Füllungsmaterial Seitenzahn-Füllungsmaterial

Use only as a system!

Filtek LS Restorative Low Shrink Posterior Niedrig schrumpfendes Seitenzahn-Füllungsmaterial

Low Posterior Restorative NiedrigShrink schrumpfendes Seitenzahn-Füllungsmaterial Silorane Silorane System System Adhesive Adhesive Adhesive Silorane System Adhesive Self-Etch Self-Etch Self-Etch Primer Primer and Primer Bond and andAdhesive Bond Bond LS System Silorane System Adhesive Self-Etch Selbstätzender Selbstätzender Selbstätzender Primer Primer und Primer Bond und und Bond Bond Primer and Bond Self-Etch Primer and Bond Self-Etch Primer and Bond Selbstätzender Primer und Bond Selbstätzender Primer und Bond

™ Filtek Silorane Use only as a system!

Use only Use asonly only a system! as aa system! system! Use as

1

Use only as a system!Low Shrink Posterior Restorative Niedrig schrumpfendes Seitenzahn-Füllungsmaterial

Silorane System Adhesive Self-Etch Primer and Bond Selbstätzender Primer und Bond

1

1

11

2

1

3

35

3

16

2 2

4

7

7

10

8

8

11

3M ESPE 3M ESPE Filtek Silorane Filtek Silorane

26

9

Made in U.S.A. Made by in U.S.A. by 3M ESPE3M ESPE Dental Products Dental Products St. Paul, MN 55144-1000 St. Paul, MN 55144-1000 10 EC REP EC REP 3M ESPE3M AGESPE AG

2

6

5 5

5 4

66

6

55

3

22

44

4

33

4

5

2

3 Use only as a1 system!

3

6

7

7

7 8

9

5 9

9 10

9

12

4 8

6 10

3M ESPE Filtek Silorane Silorane System SiloraneAdhesive System Adhesive Made in U.S.A. by 3M ESPE Made in Germany by Made in Germany by Dental Products 3M ESPE AGESPE AG 3M St. Paul, MN 55144-1000 Dental Products Dental Products D-82229 Seefeld D-82229- Germany Seefeld - Germany EC REP 3M ESPE AG Dental Products

Silo

Ma 3M Den D-8

Indications

INDICATIONS, SHADES AND COMPOSITION

Filtek™ LS Low Shrink Posterior Restorative, together with LS System Adhesive Self-Etch Primer and Bond, is a system for direct, posterior restorative filling. It can be used for the following posterior restorations:

• Class I • Class II

Filtek LS restorative and LS system adhesive may be used together with glass ionomer cements or resin-modified glass ionomer cements, as cavity liners or bases. Composites and compomers (including flowable composites and compomers), which are bonded to the tooth substance using an adhesive, may not be used as a liner or base under a Filtek LS filling.

Shades Filtek LS posterior restorative is offered in the shades A2, A3, B2 and C2. All shades are radiopaque.

Composition Filtek LS Low Shrink Posterior Restorative:

• Silorane resin • Initiating system: camphorquinone, iodonium salt, electron donor • Quartz filler • Yttrium fluoride • Stabilizers • Pigments

LS System Adhesive Self-Etch Primer:

• Phosphorylated methacrylates • Vitrebond™ copolymer • BisGMA • HEMA • Water • Ethanol • Silane-treated silica filler • Initiators • Stabilizers

LS System Adhesive Bond:

• Hydrophobic dimethacrylate • Phosphorylated methacrylates • TEGDMA • Silane-treated silica filler • Initiators • Stabilizers

27

QUESTIONS AND ANSWERS

Questions and Answers • What is the difference between Filtek™ LS Low Shrink Posterior Restorative and conventional composites currently on the market?

Conventional composites utilize methacrylate resins. Filtek LS restorative is based on new silorane resin technology. Because of this new resin technology, a dedicated adhesive, 3M™ ESPE™ LS System Adhesive Self-Etch Primer and Bond is required. Together they are referred to as the Filtek™ LS System

• Has this “new” silorane chemistry been thoroughly tested?

Yes, the Filtek LS System has been thoroughly tested throughout the development process by dentists and academics world wide. Beyond tests needed to comply with regulatory requirements, numerous additional studies were completed. The data show that the Filtek LS System performs well in both in vitro and in vivo studies.

• For what indications can I use the Filtek LS System? Filtek LS restorative and LS System Adhesive form a system for direct posterior filling procedures: Class I and II.

• Do I need any special moisture-control precautions when placing fillings with the Filtek LS System? No. The same isolation techniques are used for the Filtek LS System as any other conventional composite/adhesive system. Rubber dam is recommended, but not mandatory.

• Do I need to prepare the cavity in a special way for Filtek LS System restorations? No. Filtek LS restorative/LS System Adhesive has to follow the usual guidelines for adhesive restorations; i.e., minimal invasive treatment, no special undercuts and beveled margins as needed.

28

QUESTIONS AND ANSWERS

• Why do I need a dedicated adhesive? Conventional dental adhesives on the market today were developed for methacrylate-based filling materials. The Filtek LS System is based on a completely new resin system, so a new adhesive is needed to provide optimum system performance.

• Can I use Filtek LS restorative with other adhesives than LS System Adhesive? No. The use of a different adhesive will lead to inadequate bond strength between the adhesive and the restorative. The longevity of the restoration may be jeopardized.

• Can the LS System adhesive be used with conventional methacrylate composites? No. LS System Adhesive has been designed for the use with Filtek LS Low Shrink Posterior Restorative only. The use of LS System Adhesive with a conventional composite will lead to inadequate bond strength between the adhesive and the restorative. The longevity of the restoration may be jeopardized.

• Why did 3M ESPE make LS System Adhesive a 6th generation adhesive?

Self-etch adhesives are known for their reduced risk of post-op sensitivity compared to total-etch systems. A major goal of silorane technology is to reduce shrinkage and polymerization stress, which can lead to a reduction in the risk of post-operative sensitivity. Coupling a self-etch adhesive with this low-shrink restorative will maximize this benefit.

• What happens if I separately etch enamel and/or dentin before applying the LS System Adhesive? On dentin and prepared enamel, the self-etching LS System Adhesive needs no additional etching step. However, a separate etch will not reduce the bond strength.

29

QUESTIONS AND ANSWERS

• Should I etch uncut enamel before bonding? Yes. Due to the mild etching of 3M™ ESPE™ LS System Adhesive, it is recommended to use a phosphoric acid etch on uncut enamel prior to application of LS System Adhesive.

• Can I wet my instrument with LS System Adhesive for placing and modeling of Filtek™ LS Low Shrink Posterior Restorative? No. Using an adhesive to lubricate an instrument for placing Filtek LS restorative is not recommended.

• Can I use the Filtek LS System in a “sandwich” technique with GIC/RMGIC as a base or liner? Yes. Filtek LS restorative and LS System Adhesive may be used together with glass ionomer or resin-modified glass ionomer liners or bases that do not require a separate adhesive.

• Can I use Filtek LS restorative as a base filling and cover it with a methacrylate composite? No. Filtek LS restorative should not be used as a base under a conventional composite. Filtek LS restorative requires use of LS System Adhesive dedicated adhesive system. LS System Adhesive is not compatible with conventional methacrylates.

• Can I use a flowable composite as a liner? No. Flowable composites and compomers should not be used as liners under a Filtek LS System filling. These materials require use of a conventional dental adhesive. Traditional dental adhesives are not compatible with the Filtek LS Low Shrink Posterior Restorative. If a liner is desired, a GI or RMGI such as Vitrebond™ or Vitrebond™ Plus Light Cure Glass Ionomer Liner/Base is recommended.

30

QUESTIONS AND ANSWERS

• Can Filtek LS restorative fillings be repaired with a conventional methacrylate composite system? Yes, conventional adhesives can be used to bond methacrylate composites to cured Filtek LS restorative. Of course, Filtek LS restorative can also be repaired using the Filtek LS System adhesive and restorative.

• Why does Filtek LS restorative contain a quartz filler? The silorane resin is compatible with the surface chemistry of quartz. In addition, the refractive indices of quartz filler and the silorane resin match, which provides for a clinically acceptable opacity. Radiopacity is provided by the addition of yttrium fluoride.

• What is the particle size of the quartz filler? The average particle size of the quartz is 0.47 µm with a particle size range of .04 to 1.7µm.

• Can I use a “bulk placement” technique with Filtek LS restorative? What is the depth of cure? No. Filtek LS restorative has to be placed incrementally. Increment depth should be 2.5 mm or less.

• Do I need to dim the operatory light during placement of Filtek LS restorative? No, Filtek LS restorative allows up to 9 minutes of working time under full operatory light conditions.

31

QUESTIONS AND ANSWERS

• Can I use high-power curing lights, such as plasma arc lamps or lasers, for curing Filtek™ LS Low Shrink Posterior Restorative? No. In the case of silorane chemistry, both the light intensity and a minimum light exposure time are critical to polymerize the restorative. This minimum exposure time would cause too much heat generation when using a plasma arc or laser.

• What’s the difference between shrinkage and stress? Shrinkage is the process of volumetric contraction upon curing of the composite. Stress is the force that the shrinking composite exerts on the surrounding tooth structure.

• If I carefully layer my methacrylate composite, don’t I compensate for the shrinkage?

32

The layering technique does compensate for shrinkage to a certain degree. However, even when applying a sophisticated layering technique, methacrylate composites will produce a significantly higher polymerization stress compared to the low-shrink and low-stress optimized Filtek™ LS Low Shrink Posterior Restorative System.

SUMMARY

Summary Managing polymerization shrinkage, especially in the posterior region, is one of the most pressing challenges that is still not fully addressed with state-of-the-art composite filling materials. Over the last ten years several attempts were made to gain a low-shrinking material, but today still the vast majority of composites on the market show volume shrinkage values in the range of 2-3%.

3M™ ESPE™ Filtek™ LS Low Shrink Posterior Restorative is part of a revolutionary new filling system that will herald a new era in restorative dentistry. In contrast to conventional, methacrylate-based composites, Filtek LS restorative is polymerized in a ring-opening polymerization reaction. Filtek LS restorative is characterized by the lowest polymerization shrinkage on the market. Featuring a polymerization shrinkage of less than 1% also contributed greatly in reduction of polymerization stress. Lower polymerization stresses potentially reduce the risk of post-operative sensitivity, cusp deflection and, therefore, enamel cracks.

Furthermore, low polymerization shrinkage and stress, in combination with excellent adhesive properties of the 3M™ ESPE™ LS System Adhesive Self-Etch Primer and Bond, result in an excellent marginal integrity of Filtek LS System restorations.

The LS System Adhesive is a dedicated adhesive leveraging 3M ESPE̓s long-term experience on self-etch adhesives. The composition of LS System Adhesive especially addresses the technological needs of adhesive bonding of the new Filtek LS restorative resin to enamel and dentin.

Filtek LS restorative and LS System Adhesive represent the next generation of restorative filling materials, combining esthetics and mechanical properties you know for conventional hybrid composites with low polymerization shrinkage due to a revolutionary new resin system. The system is well proven by scientific researchers all over the world, confirming the mechanical strength and convenient clinical handling of the Filtek LS System.

33

LITERATURE

Literature Braem M. J., Davidson C. J., Lambrechts P., Vanherle G. (1994), In vitro flexural fatigue limits of dental composites. J Biomed Mater Res 28:1397-402. Braga R. R. and Ferracane J. L. (2004), “Alternatives in Polymerization contraction stress management.” Crit Rev Oral Biol Med 15:176-78. Bouillaguet S., Gamba J., Forchelet J., Krejci I., Wataha J. C. (2006), Dynamics of composite polymerization mediates the development of cuspal strain. Dent Mater 22:896-902. Braga R. R. and Ferracane J. L. (2004), Alternatives in Polymerization Contraction Stress Management. Crit Rev Oral Biol Med 15(3):176-184. Brandenbusch M., Meyer G. R., Canbek K., Willershausen B., Ernst C. P. (2007), One year performance of an innovative silorane posterior composite. IADR 2007, Abstract #1581. Cook W. D., Beech D. R., Tyas M. J. (1985), Structure and properties of methacrylate based dental restorative materials. Biomaterials 6:362-368. DeGee A. J., Feilzer A. J., Davidson C. L. (1993), True linear polymerization shrinkage of unfilled resins and composites determined with a linometer. Dent Mater 9:11-14. De Munck J., Van Landuyt K., Peumans M., Poitevin A., Lambrechts P., Braem M., Van Meerbeek B. (2005), A Critical Review of the Durability of Adhesion to Tooth Tissue: Methods and Results. J Dent Res 84(2):118-132. Dogon I. L. (2004), A Histological Evaluation of a New Adhesive/Composite Restorative System. IADR 2004, Abstract #4093. Ernst C. P., Meyer G. R., Klöcker K., Willershausen B. (2004), Determination of polymerization shrinkage stress by means of a photoelastic investigation. Dent Mater 20, 313-321. Guggenberger R., Weinmann W., Kappler O., Fundingsland J., Thalacker C. (2007), Historical Evolution of Volumetric Polymerization Shrinkage of Restorative Composites. IADR 2007, Abstract #0403. Guggenberger R. and Weinmann W. (2000), “Exploring beyond methacrylates.” Am J Dent 13 (Spec No):82D-84D. Hickel R. and Manhart J. (2001), Longevity of restorations in posterior teeth and reasons for failure. J Adhes Dent 3(1):45-64.

34

LITERATURE

Ilie N. and Hickel R. (2006), Silorane-based Dental Composite: Behavior and Abilities. Dental Materials Journal 25:3. Palin W. M., Fleming G. J. P., Nathwani H., Burke F. J. T., Randall R. C. (2005), In vitro cuspal deflection and microleakage of maxillary premolars restored with novel low-shrink dental composites. Dent Mater 21:324-335. Palmer T. M., Gessel T. F., Christensen C. C., Melonakos S. J., Ploeger B. J. (2005), Volumetric Shrinkage of “Low Shrinkage” Composite Resins. IADR 2005, Abstract 0296. Schattenberg A., Meyer G. R., Willershausen B., Ernst C. P. (2007), Shrinkage stress of new experimental low-shrinkage resin composites. IADR 2007, Abstract #0412. Schweikl H., Schmalz G., Weinmann W. (2004), The Induction of Gene Mutations and Micronuclei by Oxiranes and Siloranes in Mammalian Cells in vitro. J Dent Res 83:17-21. Watts D. C. and Cash A. J. (1991), Determination of polymerization shrinkage kinetics in visible-light-cured materials: methods development. Dental Materials 7:281-287. Watts D. C., Marouf A. S., Al-Hindi A. M. (2003), Photo-polymerization shrinkage-stress kinetics in resin-composites: methods development. Dental Materials 19:1-11. Watts D. C. (2005), Shrinkage-Stress Kinetics of Silorane versus Dimethacrylate Resin-Composite. IADR 2005, Abstract #2680. Weinmann W., Thalacker C., Guggenberger R. (2004), Siloranes in dental composites. Dent Mater 21:68-74. Yamazaki P. C. V., Bedran-Russo A. K. B., Pereira P. N. R., Swift E. J. Jr. (2006), Microleakage Evaluation of a New Low-shrinkage Composite Restorative Material. Operative Dentistry 31-6, 670-676.

35

TECHNICAL DATA

Technical Data Filtek™ LS Low Shrink Posterior Restorative

Property

36

Resin Matrix

Siloranes

Filler

Quartz and Yttrium fluoride

Filler Load by Weight (%)

76%

Average Particle Size (µm)

0.47

Curing Time (seconds)

Halogen light devices:



Output 500 – 1400 mW/cm2, 40 sec, standard mode



LED light devices:



Output 500 – 1000 mW/cm2, 40 sec, standard mode



Output 1000 – 1500 mW/cm2, 20 sec, standard mode

Increment Thickness (mm)

2.5

Volumetric Shrinkage (Bonded disc method)

0.9%

Fracture Toughness (K1C)

1.6

Flexural Fatigue Limit (MPa)

77

Compressive Strength (MPa)

394

Flexural Strength (MPa)

123

Flexural Modulus (GPa)

9.6

In vitro Wear (3-body wear in µm/cycles)

65/200,000

Number of Shades

4

37

Dental Products

3M Canada

3M Center Building 275-2SE-03 St. Paul, MN 55144-1000 U.S.A. 1-800-634-2249

Post Office Box 5757 London, Ontario N6A 4T1 Canada 1-888-363-3685

Please recycle. Printed in U.S.A. © 3M 2007. All rights reserved. 70-2013-0085-5

3M, ESPE, Adper, Elipar, Filtek, L-Pop, Prompt, Sof-Lex, Vitrebond and Z100 are trademarks of 3M or 3M ESPE. Used under license in Canada. AdheSE, Aelite, Alert, APX, Charisma, CeramX, Clearfil, Definite, ELS, Estelite, EsthetX, EvoCeram, Futurabond NR, Glacier, Gradia, Grandio, Heliomolar, Herculite, Herculite XRV, iBond, InTen-S, Miris, Optibond, Point 4, Premise, Prime & Bond NT, Prodigy, Prodigy Condensable, QuiXX, Renamel, Saremco ELS, Solitaire, Spectrum, Spectrum TPH, SureFil, Tetric, Tetric EvoCeram, TPH, TPH3, Venus, Xeno and XtraFil are not trademarks of 3M.