November Copyright DENTSPLY International

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1 November 2015 Copyright DENTSPLY International

2 Table of Contents Page 1. Introduction Background of Dental Restorative Composite Flowable Resin Composites Polymerization Shrinkage and Stress SureFil SDR flow Posterior Bulk Fill Flowable Base SureFil SDR flow+ Features and Benefits Compositions 5 2. Indications for Use 6 3. Physical Properties Depth of Cure: ISO Polymerization Shrinkage Stress Polymerization Shrinkage Fracture Toughness Compressive Strength Three-Body Wear Resistance Flexural Strength and Modulus Radio-Opacity Adaptation Sensitivity to Ambient Light (work Time) Water Solubility and Water Sorption Compatibility with Methacrylate Based Dental Adhesive Compatibility with Methacrylate Based Cap Layer Composite Property Summary Directions for Use 27 Copyright DENTSPLY International 2

3 1. Introduction 1.1. Background of Dental Restorative Composite Light cure dental restorative composites have been introduced into the field of conservative dentistry for the needs of cure on command from clinicians and esthetic appearance from patients. In general, dental composites encompass four main components: (1) the resin matrix or continuous phase comprising a combination of oligomer/monomer system, an initiator/co-initiator system and stabilizers; (2) filler consisting of inorganic particulates such as glass, and/or fused silica or mixed oxides such as silica-zirconia, with certain composites also comprise macro-filler based on pre-polymerized ground composite; (3) the coupling agent, usually an organo-silane that chemically bonds the reinforcing filler surface to the resin; (4) iron oxide pigments and sometimes radio-opacifier dispersed into the mixture of the resin matrix and surface modified filler to provide natural tooth colors and radio-opacity. The resin matrix of dental composites represents the continuous phase and can be viewed as the backbone of the inorganic/ organic composite system. The filler or dispersed phase is designed to enhance the strength of the softer organic polymer phase and usually consists of glass particles of different compositions, sizes, and size distributions. Filler size is only one of several parameters that affect the overall properties of a composite resin. The filler type, shape, and amount, as well as the filler/resin coupling agent contribute to the material and handling performance Flowable Resin Composites High viscosity resin composites (universal or posterior resin composites) are commonly used to restore teeth due to their high filler load, high mechanical strength, strong wear resistance, low shrinkage and good handling such as sculptability. However, due to the high viscosity and high stiffness of the paste, high viscosity resin composites are not easily to adapt to the internal cavity wall or small cavities. Flowable restoratives are used to compensate the adaptation challenges of high viscosity resin composites. Due to their low filler load and high flowability, flowable resin composites can easily adapt to the cavity with less or no manipulation. Dentists commonly use flowables as the first base layer or liners in posterior restorations. Due to the low mechanical strength, weak wear resistance and lack of sculptability, flowables are not used on load bearing occlusal surfaces. Especially due to their low filler load and high shrinkage, flowables are commonly considered as unsuitable for bulk placements. Copyright DENTSPLY International 3

4 1.3. Polymerization Shrinkage and Stress Visible light cured resin composites contain multifunctional, reactive monomers. When exposed to light, these monomers link together to create large molecules (polymers), which, in turn, link together to form a continuous network. The polymerization process requires that monomers physically move closer together to chemically react via a free radical process. This process results in a net loss of volume referred to as polymerization shrinkage if not restricted by e.g. bonding to a cavity. When this shrinkage process is restricted, stress builds up in the material. Not only will this polymerization stress be trapped within the composite itself, but it will also exert forces on bonded interfaces to which the composite is attached. It is the transfer of polymerization stress to tooth structure that is the cause of many clinical problems. In a well bonded composite restoration, polymerization contraction stress is transferred throughout the interface with the tooth. This force on tooth structure may result in enamel fracture, cuspal movement, and cracked cusps. In less bonded restorations, polymerization stress has the potential to initiate failure of the composite-tooth interface (adhesive failure) if the forces of polymerization stress exceed the bond strength. The resulting gap between the composite and cavity walls may produce post-operative sensitivity, microleakage, and/or secondary caries. If the bonding to the cavity walls is strong enough to avoid gap formation during polymerization, the stress concentrated inside the composite material can produce micro-cracks. Therefore, if the polymerization stress due to the shrinkage can be reduced, the longevity of composite restorations may be improved SureFil SDR flow Posterior Bulk Fill Flowable Base In 2009, DENTSPLY International introduced the first bulk fill flowable resin composite SureFil SDR flow Posterior Bulk Fill Flowable Base to the global market. With the incorporation of Stress Decreasing Resin (SDR ) technology and high depth of cure, SureFil SDR flow material has exhibited exceptional clinical performances and great commercial success. Following SureFil SDR flow material, other major dental product manufacturers started researching and developing similar products. Bulk fill resin composites as a product category have become widely accepted by both academic researchers and clinicians SureFil SDR flow+ Features and Benefits SureFil SDR flow+ Bulk Fill Flowable is a one-component, fluoride-containing, visible light cured, radiopaque resin composite restorative material. It is designed to be used as a base in Class I and II restorations. It is also suitable as a stand-alone restorative material in nonocclusal-contact applications. SureFil SDR flow+ material has handling characteristics typical of a flowable composite, but can be placed in 4mm increments with minimal polymerization Copyright DENTSPLY International 4

5 stress. SureFil SDR flow+ material has a self-leveling feature that allows intimate adaptation to the prepared cavity walls. When used as a base/liner, it is designed to be overlayed with a methacrylate based universal/posterior composite for replacing missing occlusal/facial enamel. SureFil SDR flow+ Bulk Fill Flowable is built on DENTSPLY s successful Stress Decreasing Resin technology from SureFil SDR flow Posterior Bulk Fill Flowable Base which is the most desired bulk fill flowable resin composite. SureFil SDR flow material has exhibited exceptional clinical performances and great commercial success due to their excellent physical properties, remarkable handling characteristics, and outstanding quality control. SureFil SDR flow+ material was developed to meet additional clinical needs such as improved mechanical strength, wear resistance and radiopacity which can greatly improve the efficiency and productivity of clinician s ever-increasing composite restorations. SureFil SDR flow+ Bulk Fill Flowable restorative s major features and benefits are summarized below: 1.6. Compositions SureFil SDR flow+ Bulk Fill Flowable Restorative material has incorporated 70.5 wt% / 47.4 vol% filler. The resin matrix contains proprietary modified urethane dimethacrylate resin; TEGDMA; polymerizable dimethacrylate resin; polymerizable trimethacrylate resin; camphorquinone (CQ) photoinitiator; ethyl-4(dimethylamino)benzoate photoaccelerator; butylated hydroxy toluene (BHT); UV stabilizer. The filler contains silanated barium-aluminofluoro-borosilicate glass; silanated strontium alumino-fluoro-silicate glass; surface treated fume silicas; ytterbium fluoride; fluorescent agent; synthetic inorganic iron oxide pigments, and titanium dioxide. Copyright DENTSPLY International 5

6 2. Indications for Use Base in cavity Class I and II direct restorations Liner under direct restorative materials Class II box liner Pit & Fissure Sealant Conservative Class I restorations Core Buildup Class III and V restorations Contraindications SureFil SDR flow+ material is contraindicated for: Use with patients who have a known hypersensitivity to methacrylate resins Copyright DENTSPLY International 6

7 3. Physical Properties The data presented in the following sections represents those in vitro test procedures that are designed to closely approximate clinically relevant properties of the SureFil SDR flow+ Bulk Fill Flowable Restorative material. All results for individual test presented were performed in the same laboratories under identical conditions wherever possible. Thus, within each group of test results, comparison among products may be inferred. Caution should be applied when attempting to compare similar test results from different laboratories due to potentially different test conditions, parameters, etc. Where noted, accepted, standardized International Standards Organization (ISO) test methods were utilized in performing the testing. Copyright DENTSPLY International 7

8 3.1. Depth of Cure: ISO 4049 ISO 4049 Depth of Cure. The restorative material was light cured in a stainless steel mold with a cylindrical chamber, 4mm in diameter and 6mm deep and a Whatman No. 1 filter paper background with a Spectrum 800 halogen light at an intensity of ~550 mw/cm 2, 20 seconds for Universal shade and 40 seconds for A1/A2/A3 shades or a SmartLite Focus LED light at an intensity about 1100 mw/cm 2, 10 seconds for Universal shade and 20 seconds for A1/A2/A3 shades. The uncured side was scraped away immediately after cure using a plastic spatula and the thickness of the remaining, cured composite was measured by a micrometer. The depth of cure was the remaining thickness divided by two. ISO 4049:2009E Depth of Cure (higher is better) Material Halogen Light Depth of Cure, mm LED Light Depth of Cure, mm SureFil SDR flow+, Universal Shade SureFil SDR flow+, A1 Shade SureFil SDR flow+, A2 Shade SureFil SDR flow+, A3 Shade Copyright DENTSPLY International 8

9 SureFil SDR flow+ Bulk Fill Flowable Restorative material can be placed and light cured in increments up to 4mm. Curing Recommendations Shade Light Output Cure Time: 2mm Cure Time: 4mm Universal Halogen and LED Lights mw/cm High Power LED Lights mw/cm A1, A2, A3 Halogen and LED Lights mw/cm High Power LED Lights mw/cm Refer to DFU for light compatibility and warnings. Copyright DENTSPLY International 9

10 3.2. Polymerization Shrinkage Stress The polymerization shrinkage stress was evaluated using DENTSPLY s internal method based on ADA tensometer. The polished quartz glass rods were silanated by 2% A-174 silane/acetone solution. Uncured restorative material was injected into a cell between two glass rods, 6 mm diameter x 2.0 mm deep (C-factor = 1.50). The composite was cured with a QHL75 halogen light at a light intensity of mw/cm 2 for 60 seconds. The stress was recorded 30 minutes post-cure. All stress values were normalized by the stress of SureFil SDR flow material. Polymerization Shrinkage Stress (lower is better) Copyright DENTSPLY International 10

11 The polymerization shrinkage stress of SureFil SDR flow+ Bulk Fill Flowable Restorative material is statistically equivalent to that of SureFil SDR flow material and lower than that of other bulk fill restorative composites. Copyright DENTSPLY International 11

12 3.3. Polymerization Shrinkage The polymerization shrinkage was evaluated using DENTSPLY s internal method. Cured composite specimens were prepared by curing the composite in a stainless steel mold, 2.5 mm thick x 10mm in diameter, with Halogen light Spectrum 800 for 60 seconds each side at the room temperature. The densities of uncured and 24 hour post-cured restorative materials were determined by Helium Pycnometer (MicroMeritics AccuPycII 1330/1340). The volume shrinkage was calculated as: % volumetric shrinkage = [density (cured) density (uncured)] / density (cured) x 100 Volumetric Shrinkage The polymerization shrinkage of SureFil SDR flow+ Bulk Fill Flowable Restorative material is statistically equivalent to that of SureFil SDR flow material, Filtek Bulk Fill Flowable, Beautifil Bulk Flowable and Venus Bulk Fill restorative materials. Copyright DENTSPLY International 12

13 3.4. Fracture Toughness The fracture toughness was investigated using DENTSPLY s internal method (as currently there is no ISO method for dental composites). Stainless steel mold with a stickshaped chamber, dimensions 25 x 2 x 5 mm was filled with composites and covered with a Mylar sheet. The stick-shapes specimens were prepared by light curing the composite for 20 seconds 3 times each side with a Spectrum 800 halogen light at a light intensity of 550 mw/cm 2. After storage in deionized water at 37 0 C for 24 ± 2 hours, the specimens were cut a mm deep notch by a high speed table saw. The fracture toughness was obtained in the compressive mode under a three-point loading with Instron 3366 at a crosshead speed of 0.50 mm/min. Fracture Toughness (higher is better) Copyright DENTSPLY International 13

14 The fracture toughness of SureFil SDR flow+ Bulk Fill Flowable Restorative material is statistically equivalent to that of SureFil SDR flow material and higher than that of X-tra Base or Tetric EvoFlow Bulk Fill. Copyright DENTSPLY International 14

15 3.5. Compressive Strength Compressive strength was measured based on DENTSPLY/Caulk s internal method. Glass mold, for the preparation of a cylindrical specimen, 7 mm long x 4mm in diameter, was filled with restorative composite and sandwiched between two Mylar cover sheets. The composites were light cured both sides for 20 seconds with a Spectrum 800 halogen light at a light intensity of 550 mw/cm 2. After storage in deionized water at 37 0 C for 24 hours, the specimens were polished to 6mm long x 4mm in diameter using 600 grit sand paper. The compressive strength was obtained with Instron 3366 at crosshead speed of 5 mm/min. Compressive Strength (higher is better) The compressive strength of SureFil SDR flow+ Bulk Fill Flowable Restorative material is statically better than that of SureFil SDR flow material, Tetric EvoFlow Bulk Fill as well as human dentin. Copyright DENTSPLY International 15

16 3.6. Three-Body Wear Resistance The three-body wear resistance was evaluated using DENTSPLY s internal method based on localized Leinfelder wear. Cured composite specimens were prepared by curing the composite in a stainless steel mold, 3 mm thick x 20 mm in diameter, with Triad curing light for 2 minutes each side at room temperature. The cured specimens were post-treated at 37 o C in DI water for at least 72 hours. The treated specimens were loaded onto the Leinfelder wear testing machines, using PMMA particle / water as the media. The wear testing ran 400K cycles under 75N load at 2Hz. The wear volume loss was measured by Talysurf CLI 1000 profilometer (Taylor Hobson Precision). Wear Volumetric Loss (lower is better) It was found the three-body wear volumetric loss of SureFil SDR flow+ Bulk Fill Flowable Restorative material is statically equivalent to that of Esthet-X Flow material and better than that of SureFil SDR flow material. Copyright DENTSPLY International 16

17 3.7. Flexural Strength and Modulus Flexural Strength was measured according to ISO Stainless steel mold with a stick-shaped chamber, dimensions 25 x 2 x 2 mm was filled with composites and covered with a Mylar sheet. The stick-shapes specimens were prepared by light curing the composite for 20 seconds 3 times both sides with a Spectrum 800 halogen light at a light intensity of 550 mw/cm 2. After storage in deionized water at 37 0 C for 24 hours, the flexural strength was obtained in compressive mode under a three-point loading with Instron 3366 at a crosshead speed of 0.75 mm/min. Flexural strength measures the strength of the material under 3-point bending. Flexural modulus measures the stiffness of the material. Flexural Strength (higher is better) Copyright DENTSPLY International 17

18 Flexural Modulus (higher is better) Both the flexural strength and flexural modulus of SureFil SDR flow+ Bulk Fill Flowable Restorative material are not statistically different from those of SureFil SDR flow material. Copyright DENTSPLY International 18

19 3.8. Radiopacity The radiopacity was measured based on ISO mm thick disk composite specimen was cured in disk stainless steel mold, 1mm thick x 30mm in diameter, with Triad 2000 for 2 minutes each side. Radiopacity of a restorative material was determined by comparing the optical density of a radiograph of a 1.0 mm thick cured material to that of a 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5 mm stepped standard aluminum block. Radiopacity (higher is better) Copyright DENTSPLY International 19

20 Radiopacity indicates the visibility of composite restorations on X-ray radiographs. As shown in the above figures, the restoration with SureFil SDR flow+ Bulk Fill Flowable Restorative material will have better visibility than the restorations with lower radiopacity restorative materials. Copyright DENTSPLY International 20

21 3.9. Adaptation The adaptation was evaluated using DENTSPLY s internal method. Caries-free, unrestored human third molars were used to prepare Class I type cavity with the approximate cavity dimension of 5mm (length) x 4mm (width) x 4mm (depth). After cleaning and drying, Prime & Bond NT was applied and light cured per DFU. SureFil SDR Flow and SureFil SDR Flow+ materials were also placed and cured without manipulation per DFU (simply dispense 4mm and cured). After restoration, teeth were sectioned into halves mesio-distally. All sectioned samples were observed using the Infinite Focus Microscope (IFM) (Alicona Imaging, Grambach/Graz, Austria) or Keyence Microscope on the composite-tooth interface. The composite-tooth interface pictures are shown as the following. SureFil SDR flow material SureFil SDR flow+ material SonicFill 2 Even with the simply dispense to 4mm and cure technique without manipulating the paste, both SureFil SDR flow and SureFil SDR flow+ materials achieved great adaptation to the irregular cavity walls and resulted in gap free restorations. As a comparison, even with proper dispensing, packing and curing per the manufacturer s directions for use, high viscosity materials such as SonicFill 2 showed poor adaptation to the cavity wall and multiple gaps can be observed in the restoration. Copyright DENTSPLY International 21

22 3.10. Sensitivity to Ambient Light (Work Time) The sensitivity to ambient light was measured based on ISO A thin film of uncured restorative material was placed on a micro slide and exposed to xenon light and ultraviolet filter with an intensity of lux in Heraeus Sun Tester box. Then the radiated restorative was sandwiched between two micro slides and the homogeneity of the restorative was observed by naked eyes. The maximum ambient light exposure time without changes in the physical homogeneity of the restorative material was recorded as work time. Work Time (higher is better) The work time of SureFil SDR flow+ Bulk Fill Flowable Restorative material is slightly longer than that of SureFil SDR flow material Copyright DENTSPLY International 22

23 3.11. Water Solubility and Water Sorption This test was based on ISO The light cured specimens (1 mm thick by 15 mm in diameter) were transferred, to a desiccators maintained at 37 0 C. After 22 hours, the specimens were removed and stored in a second desiccator maintained at 23 0 C for 2 hours and then weighed. This cycle was repeated until a constant mass, m 1, was obtained. After the final drying, measurements were made of the diameter and the thickness in order to calculate the volume, V. The specimens were immersed in water at 37 0 C for 7 days in such a way that they are vertical, having a minimum of 3 mm separation between specimens. After 7 days, the specimens were removed, washed with water, surface water blotted until free from visible moisture, dried in the air for 15 seconds, and weighed 1 min. after removal from the water. This mass was recorded as m 2. After this weighing, the specimens were reconditioned to constant mass in the desiccator. Record the constant mass as m 3. The values for water sorption, Wsp, were calculated using the following equation: Wsp = (m 2 m 3 ) / V The values for solubility, Wsl, were calculated using the following equation: Wsl = (m 1 m 3 ) / V Material Water Sorption, µg/mm 3 Water Solubility, µg/mm 3 SureFil SDR flow+ material SureFil SDR flow+ Bulk Fill Flowable Restorative material has water sorption less than 40 µg/mm 3 and water solubility less than 7.5 µg/mm 3 and therefore meets ISO 4049 requirement. Copyright DENTSPLY International 23

24 3.12. Compatibility with Methacrylate Based Dental Adhesive Notched-Edge (Ultradent) Shear Bond Strength (SBS) to tooth based on ISO 29022:2013 was used to determine enamel & dentin bonding. Freshly extracted, caries-free and un-restored human molars (for dentin) and bovine teeth (for enamel) were used. Teeth were sectioned, mounted in a cylindrical block using cold-cure acrylics, then ground with sand papers until a flat dentin or enamel surface is exposed. Tooth surface was prepared (etching, rinsing, etc) according to the bonding agent s DFU. With Prime & Bond elect, the enamel surface was total etched with Caulk 34% Tooth Conditioner Gel and the dentin surface was self-etched by the adhesive. The adhesive was applied and cured per its DFU. Then Ultradent mold opening was centered over the treated substrate. Composite was carefully placed into the mold and cured with a halogen light. After curing, the mold insert was carefully removed and the bonded specimen was stored in 37 o C DI-water for 24 hour before testing. SBS test was performed on Instron 3366 at a crosshead speed of 1 mm/min on the interface of the specimen. The maximum strength was recorded. Shear Bond Strength (Higher is better) It was found that the shear bond strengths of SureFil SDR flow+ Bulk Fill Flowable Restorative material with Prime & Bond elect adhesive on both Enamel and Dentin surfaces are statistically equivalent to those of Esthet-X Flow with Prime & Bond elect on both Enamel and Dentin surfaces. SureFil SDR flow+ Bulk Fill Flowable Restorative material is chemically compatible with methacrylate based dental adhesives. Copyright DENTSPLY International 24

25 3.13. Compatibility with Methacrylate Based Cap Layer Composite Dentsply Internal Method. In a stainless steel mode with a cavity of 4mm in diameter and 4mm of SureFil SDR flow (or SureFil SDR flow+) material was bulk placed and cured, or 2 mm of TPH Spectra LV was placed and cured incrementally. Then on top of the cured composite, two increments of TPH Spectra LV composite were placed and cured. The cured specimen was aged in DI water at 37 o C for at least 24 hours. The shear bond strength test was carried on Instron 3366 at a speed of 1mm/min. The steel chisel tip was placed perpendicular to the interface between composite layers in the specimen. The maximum strength was recorded. Shear Bond Strength (Higher is better) It was found that the shear bond strength between SureFil SDR flow+ Bulk Fill Flowable Restorative material and TPH Spectra material as the cap layer is statistically equivalent to that between SureFil SDR flow and TPH Spectra materials, or that between different layers of TPH Spectra materials. SureFil SDR flow+ Bulk Fill Flowable Restorative material is chemically compatible with methacrylate based cap layer composites. Copyright DENTSPLY International 25

26 4. Property Summary SureFil SDR flow+ Bulk Fill Flowable Technical Data Value Unit Polymerization Stress 1.8 MPa Fracture Toughness 1.9 MPa*m 1/2 Flexural Strength (ISO 4049) 119 MPa Flexural Modulus 6300 MPa Compressive Strength 260 MPa Volumetric Shrinkage 3.7 % Water Sorption (ISO 4049) 18 µg/mm 3 Water Solubility (ISO 4049) 2.4 µg/mm 3 Depth of Cure (ISO 4049) 4.3 mm Radiopacity (ISO 4049) 2.6 mm Al Work Time (ISO 4049) 100 second Filler Content 70.5 / 47.4 (weight / volume) % Filler Size (average) 4.6 µm Beautifil Bulk Flowable, Beautifil Bulk Restorative, Filtek Bulk Fill Flowable, Filtek Bulk Fill Posterior, SonicFill 2, Tetric EvoCeram Bulk Fill, Tetric EvoFlow Bulk Fill, Venus Bulk Fill, X-tra Base are not registered trademarks of DENTSPLY International. Copyright DENTSPLY International 26

27 5. Directions for Use Copyright DENTSPLY International 27

28 Copyright DENTSPLY International 28