Filtek Bulk Fill ™

Posterior Restorative

Technical Product Profile

Table of Contents

Table of Contents Introduction......................................................................................... 3 Product Description............................................................................. 4 Product Features................................................................................. 4 Indications for Use............................................................................... 4 Composition........................................................................................ 5 Shades................................................................................................ 5 Background......................................................................................... 6 Resin System.............................................................................................. 6-7 Fillers.............................................................................................................. 7

Physical Properties.............................................................................. 8 Depth of Cure............................................................................................ 9-11 Shrinkage Stress........................................................................................... 12 Cusp Deflection............................................................................................. 12 Flexural Modulus........................................................................................... 13 In-vitro, 3-Body Wear.................................................................................... 14 Polish Retention......................................................................................14-15 Fracture Toughness....................................................................................... 16 Flexural Strength and Compressive Strength................................................. 17

Questions and Answers................................................................19-22 References........................................................................................ 23

2

Introduction

Introduction Since the introduction of light curable composites, dentists have been required to place the material in increments. These composites require light (in the proper wavelength) to excite a photo-initiator, which begins the polymerization process. If the light penetration is insufficient, poor initiation of this reaction can result, which can lead to under-cured or uncured material. The depth of cure of a composite is determined by the monomers, the initiators and the shade/opacity of the material. Additionally, the effectiveness of the light is influenced by many factors including the wavelength, the light intensity, the distance from the light source, and the exposure time. Dentists use incremental placement techniques for a variety of reasons in addition to the cure depth of the composite. Incremental placement is used to manage the shrinkage and corresponding shrinkage stress, resulting from the polymerization reaction. Incremental placement allows for more precise manipulation of the restorative to ensure adaptation, particularly at the cavosurface. It reduces the possibility of voids and aids in forming contacts and sculpting the occlusal surface prior to cure. Managing the shrinkage stress and ensuring proper adaptation may reduce the incidence of post-operative sensitivity. Additionally, incremental placement readily lends itself to creating multi-shade restorations. On the other hand, incremental placement is considered time consuming and tedious, especially in posterior teeth. Increments may increase the potential of voids to form between composite layers, and composites must be placed in a dry field. The risk of contamination leading to a compromised restoration is adversely impacted by the time it takes to place, adapt and cure each increment. In an effort to provide materials that address the challenges of incremental placement, and also provide an alternative material to amalgam, packables were launched in the late 1990s. These materials had a high viscosity and contained a high filler load. Manufacturers claimed the handling was amalgam-like and the material stiffness aided in forming contacts. In addition, many of the packables were reported to have the capability of being bulk placed, i.e., to be placed and cured in 4-5 mm increments. However, the high viscosity of these composites made adaptation to the cavosurface more challenging.1,2 The actual depth of cure of these materials was found to be less than claimed.3 Even if the adequacy of cure was acceptable, the clinical ramifications of shrinkage stress became more prominent with thicker (4-5 mm) layers. Studies have shown that many of these materials still had high shrinkage and polymerization stress. The field of materials science has made remarkable advancements with composite filling materials used for direct procedures, which offer dentists solutions to many of the issues that they see every day. It is pretty widely understood in the scientific and dental communities that bulk filling a restoration increases stresses on the tooth, and can decrease bond strength. However, with the capabilities of materials currently available to manufacturers, it is possible to create materials/products that offer lower polymerization shrinkage stress when compared to incrementally placed composites.

3

Product Description

Product Description 3M™ ESPE™ Filtek™ Bulk Fill Posterior Restorative material is a visible, light-activated restorative composite optimized to create posterior restorations simpler and faster. This bulk fill material provides excellent strength and low wear for durability. The shades are semi-translucent and low-stress curing, enabling up to a 5 mm depth of cure. With excellent polish retention, Filtek Bulk Fill Posterior Restorative is also suitable for anterior restorations that call for a semi-translucent shade. All shades are radiopaque. Filtek Bulk Fill Posterior Restorative is offered in A1, A2, A3, B1 and C2 shades.

Product Features • Packaged in 0.2 gram capsules and 4.0 gram syringes ­

- Syringes are dark teal green with white labels and shade designations

­

- Capsules are black with dark teal green caps

• 5 Shades – A1, A2, A3, B1, C2 • Class II 5 mm depth of cure for all shades

Indications for Use • Direct anterior and posterior restorations (including occlusal surfaces) • Base/liner under direct restorations • Core build-ups • Splinting • Indirect restorations including inlays, onlays and veneers • Restorations of deciduous teeth • Extended fissure sealing in molars and premolars • Repair of defects in porcelain restorations, enamel and temporaries

4

Composition

Composition The fillers are a combination of a non-agglomerated/non-aggregated 20 nm silica filler, a non-agglomerated/ non-aggregated 4 to 11 nm zirconia filler, an aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles) and a ytterbium trifluoride filler consisting of agglomerate 100 nm particles. The inorganic filler loading is about 76.5% by weight (58.4% by volume). Filtek™ Bulk Fill Posterior Restorative contains AUDMA, UDMA and 1, 12-dodecane-DMA. Filtek Bulk Fill Posterior Restorative is applied to the tooth following use of a methacrylate-based dental adhesive, such as manufactured by 3M, which permanently bonds the restoration to the tooth structure. Filtek Bulk Fill Posterior Restorative is packaged in traditional syringes and single-dose capsules.

Shades Filtek Bulk Fill Posterior Restorative material is available in 5 shades: A1, A2, A3, B1 and C2. These shades are more translucent than the body or enamel shades of other universal composites.

A1

A2

B1

A3

Figure 1: Source: 3M internal data

C2

5

Background

Background Resin System The primary aim of this development effort was to design a material that would allow a practitioner to place and cure a 5 mm deep restoration up to occlusion. In order to accomplish this task, many aspects of the resin system needed to be considered. One of the primary considerations in designing this resin system was the ability to relieve the amount of shrinkage stress upon light curing. Additionally, because this is a bulk fill material, the depth of cure of the material was a key property considered during development. Unlike many of the flowable composites on the market, this material was designed to be filled up to occlusion, so attaining high wear resistance was a central effort. Another key factor that had to be considered for a material that will be filled in bulk was optimized handling and enhanced adaptation to the cavity preparation. Methacrylate composites have an inherent tendency to shrink during polymerization and can shrink to varying degrees depending on the monomers being used. Filtek™ Bulk Fill Posterior Restorative contains two novel methacrylate monomers that, in combination, act to lower polymerization stress. One monomer, a high molecular weight aromatic dimethacrylate (AUDMA) (Figure 2), decreases the number of reactive groups in the resin. This helps to moderate the volumetric shrinkage as well as the stiffness of the developing and final polymer matrix—both of which contribute to the development of polymerization stress.

Figure 2: AUDMA Structure Source: 3M internal data

The second unique methacrylate represents a class of compounds called addition-fragmentation monomers (AFM) (Figure 3). During polymerization, AFM reacts into the developing polymer as with any methacrylate, including the formation of cross-links between adjacent polymer chains. AFM contains a third reactive site that cleaves through a fragmentation process during polymerization. This process provides a mechanism for the relaxation of the developing network and subsequent stress relief. The fragments, however, still retain the capability to react with each other or with other reactive sites of the developing polymer. In this manner, stress relief is possible while maintaining the physical properties of the polymer.

Figure 3: AFM Structure Source: 3M internal data

6

Background

DDDMA (1, 12-Dodecanediol dimethacrylate) (Figure 4) has a hydrophobic backbone that increases its molecular mobility and compatibility with nonpolar resins. DDDMA offers a low viscosity/low volatility resin that is commonly used in biomaterials and dental applications due in part to its fast cure with low exotherm and low shrinkage. This is a high-modulus resin with good flexibility and impact resistance.

Figure 4: DDDMA Structure Source: 3M internal data

UDMA (urethane dimethacrylate) (Figure 5) is a relatively low-viscosity, high-molecular weight monomer. This monomer was included in the resin system to reduce the viscosity of the resin.

Figure 5: UDMA Structure Source: 3M internal data

Additionally, the higher molecular weight effectively reduces the shrinkage while still creating a tough, highly cross-linked network. By modifying the proportions of these high molecular weight monomers, a resin system with the properties of a sculptable bulk fill material was developed. The resin system also produces polymerization shrinkage stress relief and a depth of cure of 5 mm.

Fillers The fillers included in Filtek™ Bulk Fill Posterior Restorative were designed to maximize strength, wear resistance and radiopacity while minimizing shrinkage and maintaining good handling. The filler system in Filtek Bulk Fill Posterior Restorative is the same system found in Filtek™ Supreme Ultra Universal Restorative, with the important addition of agglomerate 100 nm Ytterbium trifluoride (YbF3) particles for increased radiopacity. The remaining fillers are a combination of a non-agglomerated/non-aggregated 20 nm silica filler, a non-agglomerated/non-aggregated 4 to 11 nm zirconia filler, an aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles), making the total inorganic filler loading approximately 76.5% by weight (58.4% by volume).

7

Physical Properties

Physical Properties 4mm Depth of Cure Several methods are available for characterizing the extent of polymerization of light-cured dental composite filling materials. One is the “scrape-back” method, which is the basis of the depth-of-cure method described by ISO 4049:2009. In this ISO standard, the uncured composite is placed in a cylindrical-shaped stainless steel mold and light cured from one end of the mold. The composite is immediately extracted from the mold and the unpolymerized or low-polymerized composite is scraped off the end farthest from the light. The length of the remaining “cured” composite is measured and divided by a factor of 2. This length is typically rounded to the closest integer value and claimed as the depth of cure. This follows from the ISO 4049 specification, which allows a claimed depth of cure 0.5 mm greater than half the scrape-back measurement. It has been shown that the extent of polymerization throughout this length decreases from the end closest to the light (where light intensity was greatest) to the end where the uncured material was scraped off [4]. It was also shown in [4] that the extent of polymerization at half the scraped-back length is approximately 90% of the maximum polymerization. Depth of cure for the indicated shades of Filtek™ Bulk Fill Posterior Restorative measured using the ISO 4049 standard and a 20-second cure with the Elipar™ S10 LED Curing Light using its 10 mm light guide are shown below (Table 1).

Shade

Avg. Depth (mm)

Std. Dev.

A1

4.56

0.09

A2

4.29

0.10

A3

4.40

0.06

B1

4.24

0.04

C2

4.39

0.06

Table 1. ISO 4049 Depth of Cure – Filtek™ Bulk Fill Posterior Restorative. 20s exposure, Elipar™ S10 LED Curing Light

Another common method for assessing extent of polymerization is microhardness testing, which has been shown to correlate with the extent of polymerization [5]. As in the ISO method, it is typical to place the uncured composite in some type of mold and light cure from one end of the mold. This sample is then extracted and the hardness is measured along its length. Rather than reporting the actual hardness value measured, it is more meaningful to represent the hardness at any given point within the sample as a percentage of the maximum hardness attained. It has been shown with a variety of different composites that 80% of the maximum hardness was associated with 90% of the maximum polymerization [6].

8

Physical Properties The clinical significance of both tests as described above is not known. In other words, the extent of polymerization that is needed for a durable restoration has not been determined. Some investigators have suggested 80% of maximum microhardness (equivalent to half the scraped-back length as defined by the ISO standard) as a minimum threshold [4,5]. This recommended threshold, however, is not based on clinical studies or laboratory models involving extracted teeth. Recent laboratory studies involving extracted human teeth have suggested a lower limit of polymerization at 73% of maximum microhardness or 80% of maximum polymerization [6].

5mm Depth of Cure (ex vivo tooth model)

Oregon Health & Science University The depth of cure of Filtek™ Bulk Fill Posterior Restorative prototypes was investigated in Class II slot preparations in extracted molars at the Oregon Health & Science University. The experimental tooth was placed in a simulated arch between two adjacent teeth. The depth of the preparation was 5 mm to the gingival floor with a 3 or 7 mm width and 2 mm depth (Figure 6).

1.

2. Extract restoration Center Band Axial 5mm deep 7m m 2mm

• Class II Slot Preparation in molar tooth not tapered • Metal matrix

0.1mm 1.1 2.1 3.1 4.1 5.1

Tooth Side

4. Measure Knoop Microhardness a) along band side, b) down middle, c) along axial side of tooth in 1 mm increments starting 0.1 mm from top and 0.5 mm within the band and tooth side surfaces. Band Side

3. Cut restoration through middle in the mesial-distal direction

Figure 6: Source: Oregon Health & Science University

9

Physical Properties

Prior to placement, the preparation was lightly coated with petroleum jelly to facilitate extraction of the restoration. A circumferential metal Tofflemire matrix was applied and the composite was placed in one 5 mm increment and light cured either with a single or a multi-sited exposure with an Elipar™ S10 LED Curing Light. The curing lamp was measured to have an output of 1,000mW/cm2. After curing, the restorations were recovered and sectioned mesiodistally. Microhardness was then measured at three locations down the length of the restorations—1) 0.2 mm within the composite adjacent to the matrix band, 2) down through the center of the restoration, and 3) 0.2 mm within the composite adjacent to the axial face of the preparation (Figure 7). Three pastes differing in opacity were investigated. The results obtained with the paste with the highest opacity, which most resembles the final prototype, are presented below. Twelve replicates were run for each exposure condition. Figure 7 reveals a spatial dependence of cure at the deepest (5.1 mm) portion of the restoration with the hardness adjacent to the metal matrix band exhibiting the lowest value. It is also apparent that the hardness does not meet the 80% threshold at any of the locations measured at this depth. At 4.1 mm depth, the interfacial hardness adjacent to the tooth is comparable to that at the middle of the restoration, while the hardness adjacent to the matrix band is suppressed below the 80% threshold. While the curing conditions are not sufficient to meet the threshold cure throughout the Class II restoration at a depth of 4 mm, the results support a sufficient exposure for a 4 mm depth of cure in a Class I restoration where, based on these results, the extent of cure at the tooth-composite interface and down the middle of the restoration are similar.

70.0

Figure 7: Hardness versus depth. 20-second occlusal cure, 1000mWcm-2, 7 mm diameterwide restoration

Knoop Hardness

Source: Oregon Health & Science University

60.0 80% of maximum hardness

50.0 40.0 0.2mm Tofflemire

30.0

Middle

20.0

0.2mm tooth edge

10.0 0.0 0.0

1.0

2.0

3.0

4.0

5.0

6.0

Depth / mm

70.0 60.0

Hardness

50.0 10

40.0

80% of maximum

0.2mm Tofflemire

80% of maximum hardness

Middle 0.2mm tooth edge

Physical Properties

0.2mm Tofflemire

Middle 1.0 2.0 3.0 4.0 5.0 6.0 0.2mm toothprotocol edge has been An alternative, multi-sited curing shown Depth / mmto be effective for bulk light-cured composite materials in 10.0 Class II restorations made in extracted human teeth [10]. In this investigation, the restoration was first exposed with the light 0.0 from the occlusal surface followed by subsequent exposures from the buccal and lingual surfaces. This multi-sited approach to be effective 2.0 in obtaining a 53.0 mm depth of cure II restoration using 0.0 was shown1.0 4.0 in the Class 5.0 6.0the prototype composite as shown in Figure 8. In this case, the protocol included a 10-second occlusal cure and an additional Depth / mm 10-second cure from both the mesio-buccal and linguo-buccal directions after removing the matrix band. Since the attenuation of light through tooth mineral is likely greater than that through the prototype composite (Figure 8), the 70.0 multi-sited cure technique was duplicated for a 3 mm diameter-wide restoration, thereby creating a greater curing challenge. 60.0 The results are depicted in Figure 9. In both cases, the multi-sited curing technique was effective in achieving the threshold of 80% maximum hardness.

Knoop Hardness Knoop Hardness

Knoop Knoop Hardness

60.0 30.0 50.0 20.0 40.0 10.0 30.0 0.0 20.00.0

50.0 70.0

Hybrid Layer

40.0 60.0 30.0 50.0

0.2mm tooth edge

20.0 40.0

Middle

10.0 30.0

0.2mm Tofflemire

0.0 20.0

80% of maximum hardness

80% of maximum hardness

0.2mm tooth edge 0.0

Middle 1.0

2.0

0.2mm Tofflemire

10.0

3.0

4.0

5.0

Figure 8: Hardness versus depth. 10s occlusal/ 10s mesio-buccal/ 10s linguo-buccal, 7 mm diameter restoration, 1000mWcm-2 Source: Oregon Health & Science University

6.0

Depth / mm

0.0 0.0

1.0

2.0

3.0

4.0

5.0

6.0

Depth / mm

60.0

Figure 9: Hardness versus depth. 10s occlusal/ 10s mesio-buccal/ 10s linguo-buccal, 3 mm diameter restoration, 1000mWcm-2

Knoop Hardness Knoop Hardness

50.0 40.0 60.0

80% of maximum hardness

Hybrid Layer

30.0 50.0

0.2mm tooth edge

20.0 40.0

Middle

80% of maximum hardness

0.2mm Tofflemire 10.0 30.0

0.2mm tooth edge Middle

0.0 20.0 0.0 10.0 0.0

Source: Oregon Health & Science University

1.0

0.2mm2.0 Tofflemire

3.0

Depth / mm

4.0

5.0

6.0 11

Physical Properties

Shrinkage Stress Cusp Deflection Shrinkage can cause stress in the tooth, the bonding layer and within the composite. Stress can be a result of the combination of shrinkage and modulus. For materials with similar shrinkage, the material with the higher modulus (or stiffness) will produce greater stress. Conversely, for materials with similar modulii, the material that exhibits the highest shrinkage will produce greater stress. Cusp deflection is a 3M test method that was designed to provide a relative estimate of polymerization shrinkage stress resulting from placing and curing a dental composite in a 4x4 mm open-ended cavity. The cavity dimension roughly simulates a large cavity preparation (e.g., mesial – occlusal – distal (MOD) preparation). The surface of the aluminum cavity is sandblasted, silane treated and a dental adhesive is applied. A composite is then placed in the aluminum cavity to a final depth of 4 mm, either incrementally or bulk filled, and cured with a dental curing light (e.g., one 4 mm deep application of bulk fill composite or two 2 mm deep increments of incremental composite, each placed and light cured). A linear variable displacement transducer is used to measure the displacement of the aluminum cavity wall due to polymerization shrinkage stress. Aluminum was selected as the block material because it has a modulus similar to human enamel. A similar cusp deflection method using an aluminum block has been described in the literature.4

14

Figure 10: Cusp Deflection of common bulk fill and incrementally placed composites

12 Cusp Deflection (microns)

Source: 3M internal data

10 8 6 4 2 0 Filtek™ Filtek™ HyperFIL™ QuiXX® SureFil™ X-tra fil SonicFill™ Grandio® Herculite® TPH Bulk Fill Posterior Posterior SO Ultra Spectra™ Z250 HV Posterior Restorative Restorative Universal Restorative

16 14

12

ral Modulus (Gpa)

Park J, Chang J, Ferracane J, Lee IB: How should composite be layered to reduce shrinkage stress: Incremental or bulk filling? Dental Materials 2008; 24:501-1505.

4

12 10

8 6

Cusp Deflection (microns) Cusp Deflection (microns)

10

14 8

Physical Properties

12 6 10 4

8 Flexural Modulus 2 6 Flexural modulus is a method of defining a material’s stiffness. A high modulus indicates a rigid material. The flexural 0 modulus is measured by applying a load to a material specimen that is supported at each end. A low flexural™ modulus ™ Filtek HyperFIL™ QuiXX® SureFil™ X-tra fil SonicFill™ Grandio® Herculite® TPH 4 Filtek can aid in reducing duringPosterior cure. Bulk Fill stress generated Posterior SO Ultra Spectra™ Z250 2

HV

Restorative Restorative

Posterior

Universal Restorative

0 Filtek™ SureFil™ X-tra fil SonicFill™ Grandio® Herculite® TPH Filtek™ HyperFIL™ QuiXX® Bulk Fill Posterior Posterior SO Ultra Spectra™ Z250 HV Posterior Restorative Restorative Universal Restorative

16

Flexural Modulus (Gpa) Flexural Modulus (Gpa)

14 12

Figure 11: Flexural modulus of common bulk fill composites Source: 3M internal data

10 816 614 412 210 08 Filtek™ Bulk Fill Posterior

6

Tetric EvoCeram® Bulk Fill

HyperFIL™

SonicFill™

QuiXX® Posterior Restorative

X-tra fil

4 2 0

16

Filtek™ Bulk Fill Posterior

Polish Retention (gloss %)

Flexural Modulus (Gpa) Flexural Modulus (Gpa)

14

Tetric 70EvoCeram® Bulk Fill 60

12 10 816 614 412 210 08 Filtek™ Bulk 6 Fill Posterior 4

HyperFIL™

SonicFill™

QuiXX® Posterior Restorative

X-tra fil

50 40

20

Figure 12: Flexural modulus of common incrementally placed composites

10

Source: 3M internal data

30

0 Tetric EvoCeram® Herculite® Ultra Filtek™ Bulk Fill Posterior

TPH Spectra™ HV® SO Grandio

Filtek™ Supreme Grandio® SO ® Ultra Universal TPH Spectra™ HV Tetric EvoCeram Bulk Fill

Herculite® Ultra

2 0

2.5

Filtek™ Bulk Fill Posterior

Tetric EvoCeram® Herculite® Ultra

1.5 2.5

Grandio® SO

2 ss (MN m-3/2)

Wear (relative to Z250) 0)

Filtek™ Supreme Ultra Universal

2.5

2

12

TPH Spectra™ HV

13 1.5

0 Filtek™ Bulk Fill Posterior

Tetric EvoCeram® Bulk Fill

HyperFIL™

SonicFill™

QuiXX® Posterior Restorative

X-tra fil

Physical Properties

16

Flexural Modulus (Gpa)

14 In-vitro, 3-Body Wear 12

The wear rate was determined using an in-vitro 3-body wear test. In this test, composite (1st body) is loaded onto a 10 which contacts another wheel, which acts as an “antagonistic cusp” (2nd body). The two wheels counterrotate wheel, against 8 one another dragging abrasive slurry (3rd body) between them. Dimensional loss is determined by profilometry at the6 end of 200,000 cycles. In tests where wear is monitored at regular intervals, it is found to be linear. Consequently, wear rates can be predictive beyond the length of the actual test. 4

The 3-body wear of Filtek™ Bulk Fill Posterior Restorative is significantly less than a number of bulk fill and 2 incrementally placed composites, including SonicFill and Tetric EvoCeram Bulk Fill (Figure 13). 0

Filtek™ Bulk Fill Posterior

Tetric EvoCeram® Herculite® Ultra

TPH Spectra™ HV

Filtek™ Supreme Ultra Universal

Grandio® SO

2.5

Source: Oregon Health & Science University

14

2 3-Body Wear (relative to Z250)

Figure 13: 3 -body wear of common bulk fill and incrementally placed composites

Filtek™ Bulk SonicFill® Fill Posterior

8 6 4

0

16 14 dulus (Gpa)

0.5

10

2

14

1

0

70

Toothbrush Abrasion Composite materials were shaped into tiles and thoroughly cured. The surfaces were polished wet using a Buehler 60 variable-speed grinder-polisher to remove the air-inhibited layer and to ensure a uniform surface. They were stored in water at 37ºC for 24 hours. Gloss was measured. The samples were brushed with toothpaste and a toothbrush that was Filtek™ HyperFIL™ 50QuiXX® SureFil™ X-tra fil SonicFill™ Grandio® Herculite® TPH Filtek™ AutomaticPosterior Toothbrush Machine. Gloss measurements taken ™after Z250 500 cycles and then every 1000 Bulk Fillmounted on an Posterior SO UltrawereSpectra Restorative Posteriorcycles. The test Restorative HV Universal was terminated after 6000 toothbrush strokes. 40

Restorative

The polish retention of Filtek Bulk Fill Posterior Restorative is significantly higher than a number of bulk fill composites, including SonicFill and Tetric EvoCeram Bulk Fill (Figure 14), and significantly higher than a number of incrementally 30 placed composites, including Herculite Ultra and TPH Spectra HV (Figure 15). 20

12 10

TPH Tetric Herculite® Filtek™ Z250 QuiXX® HyperFIL™ Tetric Posterior Universal EvoCeram® Spectra™ EvoCeram® Ultra Restorative Bulk Fill HV Restorative

Polish Retention

Polish Retention (gloss %)

Cusp Deflection (microns)

12

1.5

10

Fractur

0

Filtek™ Bulk SonicFill® Fill Posterior 0.5

Tetric TPH Herculite® Filtek™ Z250 QuiXX® HyperFIL™ Tetric Universal Posterior EvoCeram® Spectra™ EvoCeram® Ultra Restorative Restorative Bulk Fill HV

Physical Properties

0 Filtek™ Bulk Fill Tetric EvoCeram® Posterior Bulk Fill 70

QuiXX® Posterior Restorative

X-tra Fil

HyperFIL™

Figure 14: Polish retention of common bulk fill composites

3

50

Source: 3M internal data

40

Fracture Toughness (MN m-3/2)

Polish Retention (gloss %)

60

SonicFill™

30 20 10

2.5 2 1.5 1 0.5

0 Filtek™ Bulk Fill Posterior

® 0SonicFill

Alert®

X-tra fil

Filtek™ Tetric Bulk Fill EvoCeram® Posterior

Herculite® Ultra

Tetric QuiXX® Surefil™ EvoCeram® Posterior Posterior ® TPHRestorative Filtek™ Z250 Filtek™ P60 Filtek Restorative Bulk™Fill Grandio Spectra™ Universal SO Supreme Posterior HV Ultra Restorative Restorative Universal

180 160

70

140 Flexural Strength (MPa)

Polish Retention (gloss %)

60 50 40 30 20

Figure 15: Polish retention of common incrementally placed composites

120 100

Source: 3M internal data

80 60 40

10 0

20

Filtek Bulk Fill 0 Posterior ™

Grandio® SO Filtek™ Bulk Fill Posterior

2.5

TPH Spectra™ HV Herculite® Ultra Tetric EvoCeram® Bulk Fill Tetric QuiXX® HyperFIL™ X-tra Fil EvoCeram® Posterior Bulk Fill Restorative

SonicFill™

200 180 160 Pa)

m-3/2)

2

140

15

4

Polish Retention (gloss %) Polish Retention (gloss %)

Flex Fl

60 60 2 50 2 50 0 40 0 ™ ® 40 Physical Properties Filtek Bulk Tetric EvoCeram Herculite® Ultra TPH Spectra™™ Filtek™™ Supreme Grandio® SO ™ ® Filtek Filtek Bulk Tetric EvoCeram Herculite® Ultra TPH Spectra Grandio® SO 30 Fill Posterior Ultra Supreme Universal HV HV Fill Posterior Ultra Universal 30 20 20 10 10 2.5 0 2.5 0 ™ ® ™ ® The values reported fracture the energy required to propagate aHerculite crack. In® Ultra this test, a Filtekfor Bulk Fill toughness Grandio(K1c) HV TPH Spectra SO are related TetrictoEvoCeram ™ ® ™ ® ® Filtek Bulk Fill Grandio TPH Spectra HV Herculite Ultra SO Tetric EvoCeram Posterior Bulk Fill 2 short bar of materialPosterior is cured. A notch is cut into it. The bar is Bulk placed Fill on a fixture that supports either end and an anvil is 2 4

positioned above the notch. The anvil presses down until the bar breaks.

1.5 1.5

The fracture toughness of Filtek™ Bulk Fill Posterior Restorative is higher than Tetric EvoCeram Bulk Fill and QuiXX Posterior Restorative (Figure 16).

1

Figure 16: Fracture 1 toughness of common bulk fill composites 0.5

2.5 2.5

0.5

Source: 3M internal data

0

0

2 Fracture Toughness (MN m-3/2) Fracture Toughness (MN m-3/2)

3-Body Wear (relative to Z250) 3-Body Wear (relative to Z250)

Fracture Toughness

® ™ ® ™ SonicFill TPH Herculite®® Filtek™™ Z250 Tetric Bulk 1.5 QuiXX HyperFIL Tetric Filtek ® ™ ™ 1.5 ® Tetric ® Herculite Z250 TPH ™ EvoCeram Bulk SonicFill QuiXX Tetric ® Spectra Filtek Posterior HyperFIL Universal Ultra Filtek Fill Posterior EvoCeram ® ™ ® Universal Posterior Fill Posterior EvoCeram Ultra Restorative Bulk Fill Spectra HV EvoCeram Restorative Restorative Restorative Bulk Fill HV 1 1

0.50.5

70 70

00 ™ ® Filtek Filtek™Bulk BulkFillFill Tetric TetricEvoCeram EvoCeram® Bulk Fill Posterior Bulk Fill Posterior

50 50

Figure 17:  Fracture 30 toughness 30 of common incrementally placed 20 composites 20 Source: 3M internal data

10 10 0

® QuiXX QuiXX® Posterior Posterior Restorative Restorative

X-tra X-traFilFil

™ HyperFIL HyperFIL™

™ SonicFill SonicFill™

The fracture toughness of Filtek Bulk Fill Posterior Restorative is higher than Tetric EvoCeram and Herculite Ultra (Figure 17).

40 40

33 2.52.5

Fracture Toughness (MN m-3/2) Fracture Toughness (MN m-3/2)

Polish Retention (gloss %) Polish Retention (gloss %)

60 60

0

2

22

1.51.5

Filtek™ Bulk ™ Filtek Bulk Fill Posterior Fill Posterior

SonicFill® ® SonicFill 11

Alert® Alert®

X-tra fil X-tra fil

Tetric Tetric ® EvoCeram EvoCeram Bulk Fill® Bulk Fill

QuiXX® ® QuiXX Posterior Posterior Restorative Restorative

Surefil™ ™ Surefil Posterior Posterior Restorative Restorative

0.50.5 00

16

™™ ®® Tetric Herculite Filtek Filtek™™ Filtek Tetric Herculite Filtek ®® BulkFillFill EvoCeram EvoCeram Ultra Supreme Bulk Ultra Supreme Posterior Ultra Posterior Ultra Universal Universal

Grandio®® Grandio SO SO

Filtek™™Z250 TPH Filtek Z250 TPH Spectra™™ Universal Universal Spectra HV Restorative HV Restorative

Filtek™™ P60 P60 Filtek Posterior Posterior Restorative Restorative

-3/2) Fracture FractureToughness Toughness(MN (MNmm-3/2 )

2.5 2 2

Physical Properties

1.5 1.5 1 1

Flexural Strength and Compressive Strength 0.5 0.5 Flexural strength is determined in the same test as flexural modulus. Flexural strength is the value obtained when the 0 sample 0 breaks. This test combines the forces found in compression and tension. Compressive strength is particularly ® ™ ™ Herculite Tetric Filtekforces Filtek™™ of chewing TPH Filtek™ Grandio®® and simultaneous Z250 Filtek P60 important because Rods®are made material applied ™ ™ ® Tetric forces. Filtek Herculite Filtek TPH ™ Filtek Filtek™of the Grandio Z250are P60to the Bulk Fill EvoCeram Ultra SO Spectra Supreme Universal Posterior ® ™ Bulk Fill EvoCeram Ultra SO Spectra Supreme Universal Posterior opposite ends of the sample length. The sample failure forces. Restorative HV tensile Posterior Ultra is a result of shear and Restorative Posterior

Ultra Universal Universal

HV

Restorative Restorative

The flexural strength of Filtek™ Bulk Fill Posterior Restorative is higher than Tetric EvoCeram Bulk Fill and QuiXX Posterior Restorative and similar to other common bulk fill composites (Figure 18).

Flexural FlexuralStrength Strength(MPa) (MPa)

180 180 160 160

Figure 18: Flexural strength of common bulk fill composites

140 140

Source: 3M internal data

120 120 100 100 80 80 60 60 40 40 20 20 0 0

Filtek™™ Filtek Bulk Fill Bulk Fill Posterior Posterior

Tetric Tetric ® EvoCeram ® EvoCeram Bulk Fill Bulk Fill

QuiXX® QuiXX® Posterior Posterior Restorative Restorative

HyperFIL™ HyperFIL™

X-tra Fil X-tra Fil

SonicFill™ SonicFill™

Flexural Strength (MPa) Flexural Strength (MPa)

The flexural strength of Filtek Bulk Fill Posterior Restorative is higher than Tetric EvoCeram and Herculite Ultra and similar to other common incrementally placed composites (Figure 19). 200 200 180 180 160 160 140 140 120 120 100 100 80 80 60 60 40 40 20 20 0 0

Figure 19: Flexural strength of common incrementally placed composites Source: 3M internal data

Filtek™ Bulk Fill ™ FiltekPosterior Bulk Fill Posterior

Tetric Tetric ® EvoCeram EvoCeram®

Herculite® Herculite®

TPH Spectra™ TPH Spectra HV ™ HV

Filtek™ Filtek™Ultra Supreme Supreme Ultra Universal Universal

Gradio® SO Gradio® SO

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Physical Properties

400 350

Source: 3M internal data

300

Compressive Strength (MPa)

Figure 20: Compressive strength of common bulk fill composites

250 200 150 100 50 0 Filtek™ Bulk Fill Posterior

18

QuiXX® Posterior Restorative

SonicFill™

HyperFIL™

Tetric EvoCeram® Bulk Fill

X-tra Fil

Questions and Answers

Questions and Answers What makes Filtek™ Bulk Fill Posterior Restorative unique? The AFM monomer used in Filtek Bulk Fill Posterior Restorative allows dentists to place one-step restorations without compromising wear resistance or stress relief. This, in addition to its excellent handling, makes Filtek Bulk Fill Posterior Restorative a truly a unique restorative material.

What is the benefit of Filtek Bulk Fill Posterior Restorative vs. incrementally placed composites? The greatest benefit is fast and easy one-step placement. You can restore a 5 mm deep Class II preparation significantly faster than placing and curing in increments.

How is Filtek Bulk Fill Posterior Restorative different than Filtek™ Bulk Fill Flowable Restorative? The greatest difference is Filtek Bulk Fill Posterior Restorative has been designed as a stress-bearing restoration with strength properties similar to other universal and posterior composite restoratives. It can also be filled to the occlusal surface up to 5 mm. On the other hand, when Filtek Bulk Fill Flowable Restorative is used in a stress-bearing Class I or II restoration, a 2 mm minimum thickness of a traditional composite must be used on the occlusal surface.

What is the volumetric shrinkage of Filtek Bulk Fill Posterior Restorative? The shrinkage of Filtek Bulk Fill Posterior Restorative is similar to Filtek™ Z250 and Filtek™ Supreme Ultra Universal Restoratives.

What’s the difference between polymerization shrinkage and polymerization stress? Polymerization shrinkage, when expressed as a volume, is simply the decrease in volume of the composite as it shrinks due to the curing process. Polymerization shrinkage stress is the stress created 1) in the bonding interface between the tooth and the shrinking composite, 2) in the tooth provided the adhesive does not fail, and 3) in the composite between the shrinking resin and the filler particles.

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Questions and Answers

Why is polymerization shrinkage stress important? Polymerization shrinkage stress can contribute to adhesive failure between the tooth and composite, which may result in post-operative sensitivity, marginal leakage and marginal discoloration. If the bond does not fail, polymerization stress may cause fracture of the enamel adjacent to the cavosurface, which may contribute to marginal ditching over time. Polymerization stress may also cause an inward deflection of the cusps in Class II restorations. Over time, composites have been observed to absorb sufficient water to compensate for some or most of this deflection.10

How do the new monomers help relieve polymerization stress? Filtek™ Bulk Fill Posterior Restorative contains two novel methacrylate monomers that, in combination, act to lower polymerization stress. One monomer, a high molecular weight aromatic dimethacrylate (AUDMA) decreases the number of reactive groups in the resin. This helps to moderate the volumetric shrinkage as well as the stiffness of the developing and final polymer matrix—both of which contribute to the development of polymerization stress. The second unique methacrylate represents a class of compounds called addition-fragmentation monomers (AFM). During polymerization, AFM reacts into the developing polymer as with any methacrylate, including the formation of cross-links between adjacent polymer chains. AFM contains a third reactive site that may cleave through a fragmentation process during polymerization. This process provides a mechanism for the relaxation of the developing network and subsequent stress relief. The fragments, however, still retain the capability to react with each other or with other reactive sites of the developing polymer. In this manner, stress relief is possible while maintaining the physical properties of the polymer.

Is this a nano-filled material? What is the filler? The filler system uses the same nanofiller technology as Filtek Supreme Ultra restoratives–a combination of silane-treated nanoclusters and individual silane-treated nanosilica and nanozirconia. In addition, it contains nano-scale ytterbium trifluoride to impart improved radiopacity.

How does the radiopacity compare to our other composites? Filtek Bulk Fill Posterior Restorative is one of our most radiopaque composites. We achieve this high level of radiopacity by incorporating nano ytterbium trifluoride.

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Questions and Answers

Why is Filtek™ Bulk Fill Posterior Restorative described as a BPA-free dental material? We’ve replaced the BisGMA monomer that is used in our other composites with a dimethacrylate that does not use Bisphenol A in its synthesis. This was done to maximize the stress relief during polymerization.

What adhesive should I use with Filtek Bulk Fill Posterior restorative? All methacrylate-based dental adhesives are compatible with Filtek Bulk Fill Posterior Restorative.

How can I be assured of getting good cavity adaptation of Filtek Bulk Fill Posterior Restorative— especially in the proximal box? Start dispensing in the deepest portion of the preparation, holding the tip close to the preparation surface. For proximal areas, hold the tip against the matrix to aid material flow into the proximal box. Withdraw the capsule tip slowly as the cavity is filled, and avoid lifting the tip out of dispensed material while dispensing to reduce voids. When dispensing has been completed, drag the capsule tip against the cavity wall while withdrawing from the operative field.

What is the curing protocol? It depends upon the class of restoration and the intensity of your curing lamp. For Class II restorations that are 5 mm deep, we instruct curing for 10 sec from the occlusal surface followed by curing 10 sec each from the mesio- and/or distobuccal and lingual directions after having removed the matrix band. For a Class I restoration, which is not likely to be more than 4 mm deep, we instruct curing from the occlusal surface for 20 sec. These times are applicable for curing lamps with an intensity of 1000mWcm-2 or greater. For curing lamps with intensities less than 1000mWcm-2, we instruct that the cure times are doubled. Caries Classification

Increment Depth

All halogen lights (with output of 550-1000mW/cm2)

3M™ ESPE™ LED lights (with output 1000-2000mW/cm2)

Classes I, III, IV and V

4 mm

40 sec

20 sec

Class II

5 mm

20 sec occlusal, 20 sec buccal, 20 sec lingual

10 sec occlusal, 10 sec buccal, 10 sec lingual

Note: For class II restorations, remove the matrix band prior to the buccal and lingual curing steps.

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Questions and Answers

Yes, but how can I be sure that I’m getting a sufficient cure at 5 mm? The three-sited curing technique that we recommend was based on in vitro studies carried out at the Oregon Health & Science University. We discovered in a 5 mm-deep Class II preparation that the cure adjacent to the metal matrix band was equivalent to the cure down the center of the restoration as well as the cure at the restoration-tooth interface when a three-sited curing technique was used. When the restoration was cured from the occlusal direction only, the cure adjacent to the metal matrix tended to be lower at deeper depths compared to the rest of the restoration. This tells us that there is less light available for polymerization adjacent to metal matrix bands at deeper depths within the restoration. A three-sited curing technique overcomes that limitation.

Does a 4 mm Class II restoration require the three-sited curing technique or can I cure it for 20 seconds as you described for a Class I? To ensure sufficient cure throughout the restoration, we recommend the three-sited curing technique be used for 4 mm Class II restorations as well.

What are the indications for use? Filtek™ Bulk Fill Posterior Restorative was designed to be durable in stress-bearing Class I and II restorations. The bulk fill capability also makes it appealing as a light-cured core build-up. In the Instructions for Use, it is noted that Filtek Bulk Fill Posterior Restorative can be used in Class III through V restorations. As Filtek Bulk Fill Posterior Restorative is semi-translucent, the esthetic outcome in anterior restorations will be affected by variables such as the location of the restoration and underlying tooth color. When esthetics are a primary outcome, we recommend using a Filtek™-branded universal restorative. See Instructions for Use for a complete list of indications.

What shades are offered and how do they compare to our other Filtek products? There are five shades of Filtek Bulk Fill Posterior Restorative: A1, A2, and A3, B1 and C2. These are based on the Vitapan Classical Shade Guide, and hence are similar to the Filtek Supreme family of composites. Filtek Bulk Fill Posterior Restorative shades, however, are more translucent than all but the translucent shades of Filtek™ Supreme family to enable the bulk curing feature.

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References

References

[1] Opdam N, Roeters F, Peters M, Burgersdijk R, Teunis M. Cavity wall adaptation and voids in adhesive Class I restorations. Dent Mater 1996; 12:230–235. [2] Opdam N, Roeters F, Joosten M, Veeke O. Porosities and voids in Class I restorations by six operators using a packable or syringable composite. Dent Mater 2002; 18:58–63. [3] Herrero A, Yaman P, Dennison J. Polymerization shrinkage and depth of cure of packable composites. Quintessence Int 2005; 36:35 –31. [4] Halvorson R, Erickson R, Davidson C. An energy conversion relationship predictive of conversion profiles and depth of cure of resin-based composite. Oper Dent 2003; 28:307-314. [5] Ferracane J. Correlation between hardness and degree of conversion during the setting reaction of unfilled dental restorative resins. Dent Materials 1985; 1:11-14. [6] Bouschlicher M, Rueggeberg F, Wilson B. Correlation of bottom-to-top surface microhardness and conversion ratios for a variety of resin composite compositions. Oper Dent 2004; 29:698-704. [7] You C, Xu X, Burgess JO. Depth of cure of core-build material with three different curing lights [abstract 1736]. J Dent Res 2001; 80:252. [8] Ernst CP, Meyer GR, Müller J, Stender E, Ahlers MO, Willershausern B. Depth of cure of LED vs QTH light-curing devices at a distance of 7 mm. J Adhes Dent. 2004; 6(2):141-50. [9] Vandevalle K, Ferracane J, Hilton T, Erickson R, Sakaguchi R. Effect of energy density on properties and marginal integrity of posterior resin composite restorations. Dent Materials 2004; 20:96-106. [10] Campodonico C, Tantbirojn D, Olin P, Versluis A. Cuspal deflection and depth of cure in resin-based composite restorations filled by using bulk, incremental and transtooth-illumination techniques. J Am Dent Assoc 2011; 142:1176-1182.

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3M, ESPE, Elipar, Filtek, Scotchbond, Soft-Lex and Vitrebond are trademarks of 3M or 3M Deutschland GmbH. Used under license in Canada. © 3M 2015. All rights reserved. Alert, Grandio SO, Herculite, HyperFIL, QuiXX, SonicFill, SureFil, Tetric Evo Ceram, TPH, Spectra, VITAPAN and X-tra fil are not trademarks of 3M.