Kalore technic al manual the science behind the smile
Over 100 scientists, chemists and researchers are focused on research and developing dental materials, fostering innovation and technological advances, utilizing a new, state-of-the-art facility. "As a leading dental company, we strongly feel the need to act as a bridge builder between dentistry and other medical specialities as well as our industry, and properly transfer their technologies into custom-made technologies useful for the further improvement of oral heath of people throughout the world." Mr.
Fast-paced and creative advances are enabled by the open layout and "communication loop" at the new research facility. A Legacy of Quality and Innovation • • • • In 2000, GC Corporation became the first company in the dental industry to receive the Deming Application Prize. In 2004, GC became the 18th company in the world to receive the "Japan Quality Medal," the highest echelon in quality control in Japan. GC Corporation became one of the earliest to receive an ISO 9001 certification in 1994.
Table of Contents 1.0 Introduction 6 2.0 6 Product Description 3.0 Indications For Use 4.0 Composition 4.1 4.2 4.3 4.3 5.0 5.1 5.2 5.3 5.4 5.5 Matrix Fillers Interfaces Initiators 6.1 Shrinkage 6.2 Shrinkage Stress 6.3 Modulus of Elasticity 6.4 Fracture Toughness 6.5 Flexural Strength 6.6 Three-Body Wear Resistance 6.7 Surface Gloss 6.8 Depth of Cure 6.9 Radiopacity 6.
7.0 7.1 7.2 7.3 7.4 7.5 7.6 7.7 8.0 Shades and Esthetics Shade Ranges Universal Shades Opaque Shades Translucent Shades Chameleon Properties Shade Guide Shade Selection for Existing and New Users 22 23 23 24 24 26 27 27 Cytotoxicity Data 29 9.0 Clinical Investigations 30 10.0 LITERATURE 31 11.0 31 ORDERING INFORMATION 12.0 Instructions For Use 32 13.0 Summary 34 14.
1.0 Introduction GC Corporation is a world leader in the field of crown and bridge composite resins, with products that include GRADIA®, a micro-ceramic composite, and GRADIA® FORTE – a nano-hybrid composite. Expertise in durable, esthetic indirect composites that were excellent alternatives to porcelain led GC Corporation to develop GRADIA® DIRECT – a direct composite material offering easy handling and unrivaled esthetics using one shade.
3.0 Indications For Use • Direct restorative for Class I, II, III, IV and V cavities • Direct restorative for wedge-shaped defects and root surface cavities • Direct restorative for veneers and diastema closure 4.0 Composition KALORE consists of a matrix, fillers, photo initiator and pigment (Table 1). 4.1 Matrix Table 1. Composition of KALORE. The matrix contains a mixture of urethane dimethacrylate (UDMA), dimethacrylate co-monomers and DX-511 monomer.
4.3 Interface The interface between the pre-polymerized fillers and the resin matrix is a critical factor. In KALORE there are three types of interactions at this interface that help to prevent early catastrophic failure. The three types of interactions are as follows: 1. Covalent bonds derived from C=C. Both the pre-polymerized fillers and methacrylate matrix monomers contain C=C groups which can cross-link with each other. Although the methacrylates are mostly cured, residual C=C groups still remain. 2.
5.1 The Importance of Low Polymerization Shrinkage (Stress) Low shrinkage and low shrinkage stress are important for several reasons. Shrinkage stress occurs when the resin matrix in composite resins shrinks in volume during polymerization, while the particles retain their pre-polymerization volume. The resulting stress at the filler and resin matrix interface remains within the cured composite resin and can lead to early replacement of restorations, as particles will be lost from the matrix.
5.3 Reducing Polymerization Shrinkage Polymerization shrinkage is influenced by clinical technique and manufacturing of the composite resin. There are several ways to reduce shrinkage from a manufacturing perspective, as described below. Table 2. Molecular weight of monomers typically used in dental composites. Increase Filler Loading Increasing filler loading in the resin matrix reduces polymerization shrinkage by decreasing the proportion of monomer content, thereby reducing shrinkage (Fig. 4).
5.4 Reducing Polymerization Shrinkage Stress Polymerization shrinkage stress is the force generated at polymerization. During polymerization, the bonded composite resin will pull towards the cavity walls as shrinkage occurs. This force is shrinkage stress. At a given level of shrinkage, the most rigid materials result in the highest stress. The modulus of elasticity (Young’s modulus) measures the rigidity of a material (its ability to resist deformation).
5.5 GC Corporation’s Technology for Reduction of Shrinkage (Stress) The new monomer DX-511, licensed from DuPont under an exclusive partnership agreement, is based on urethane dimethacrylate chemistry and designed to combine excellent handling and physical properties with low shrinkage (stress). DX-511 is compatible with all current composite and bonding systems. DX-511 Monomer The molecular structure of DX-511 includes a long rigid core and flexible reaction arms.
6.1 Shrinkage Independent Testing - ACTA Figure 9. Volumetric shrinkage of various composite materials versus time. Source: ACTA, Amsterdam. Independent testing of volumetric setting shrinkage was conducted for several composites at the ACTA, Shrinkage (Vol.%) Amsterdam. Measurements were 14 continuously recorded using a mercury 12 dilatometer. To conduct the test, composite was applied to the bottom 10 surface of a glass stopper, which was 8 then inserted into the mercury dilatometer.
Independent Testing - Indiana University Independent testing of volumetric shrinkage on the same types of composites was conducted at a third site by Dr. Jeffrey A. Platt in the Division of Dental Materials, Indiana University School of Dentistry. Approximately 20 quarts of distilled water were poured into a Styrofoam container and allowed to stand overnight. The next day, the water temperature was recorded and checked periodically during the day for temperature stability.
Figure 11. Volumetric shrinkage of various composite materials. Source: GC Corporation. Setting shrinkage was measured in-house, in accordance with ISO Draft 2007-07-10 Dentistry - Polymerization shrinkage of filling materials. Pre- and post-curing composite resin densities were measured and the polymerization shrinkage calculated accordingly. KALORE demonstrated one of the lowest levels of volumetric shrinkage of all composites tested (Fig. 11).
Independent Testing of Shrinkage Stress - OHSU Independent testing of shrinkage stress using a Bioman stress measurement device was conducted by Dr. Ferracane at OHSU School of Dentistry. This test uses a cantilever load-cell (500 kg) fitted with a rigid integral clamp, with a circular steel rod (10 mm diameter x 22 mm long) held vertically and perpendicular to the load-cell axis by the end of the cantilever.
Before each stress measurement, two pieces of quartz rod (6 mm in diameter) were flattened and polished with 600 grit wet silicon carbide paper, and two layers of silanation were applied to one end of each rod. The upper rod was mounted with the silanated end pointing down. Then the bottom quartz rod was aligned vertically to the upper rod and mounted with the silanated end pointing up. The distance between the two silanated ends was fixed at 2.25 mm for all samples.
Setting shrinkage stress was measured in-house using a universal testing machine EZ-S (Shimadzu) with a custom-made jig. Two glass slides were pre-treated with sandblasting and a silane coupling agent, then attached to both the upper and the lower jig. A composite resin sample (1.66 mL) was placed on the lower glass slide and pressed by lowering the upper glass slide on it until a 4 mm clearance remained between the upper and lower glass slides. Figure 14. Shrinkage stress of various composite materials.
6.4 Fracture Toughness Figure 17. Fracture toughness of various composite materials. Source: GC Corporation. Fracture toughness, a measure of a material’s ability to resist the propagation of a formed crack, is defined as the toughness against bending stress. The toughness is calculated as the underlying area of a stress-strain curve. A higher value for fracture toughness implies greater resistance to the catastrophic propagation of cracks. KALORE demonstrated high resistance to crack propagation (Fig.
6.6 Three-Body Wear Resistance Figure 20. Three-body wear resistance test set-up. To measure three-body wear resistance in-house, composite specimens were prepared and moved up and down along a 5 cm path at a rate of 30 strokes per minute. They were held in indirect contact with an acrylic plate under a load of 350 gf and, simultaneously, the sample holder slid horizontally along a 2 cm path at a rate of 30 strokes per minute.
Figure 23. Surface gloss of various composite materials. Source: GC Corporation 6.7 Surface Gloss To test surface gloss, samples 15 mm in diameter and 1.5 mm thick were lightcured and finished with 600 grit sandpaper. Finished samples were polished in steps with GC Pre-Shine, GC Dia-Shine and GC Dia Polisher paste. After each polishing step, the surface gloss rate was measured using a VG-2000 (Nippon Denshoku). KALORE was found to have a gloss rate among the highest of all materials tested (Fig. 23).
6.10 Handling and Working Time The working time of various composite materials was tested. The working time for KALORE was found to be sufficient, at 135 seconds (Fig. 26). Figure 26. Working time of various composite materials. Source: GC Corporation. Working Time (sec) KALORE Tetric Evoceram† Premise† EsthetX† Filtek Silorane† Filtek Z250† Filtek Supreme DL† 0 100 200 300 400 500 600 7.
7.1 Shade Ranges The shades of KALORE are designed for single and multi-shade layering techniques. KALORE has three clearly defined shade groups with clearly defined colors for easy recognition: • Universal shades (color code on unitip cap / syringe label: green) • Opaque shades (color code on unitip cap / syringe label: burgundy) • Translucent shades (color code on unitip cap / syringe label: grey) The universal shades are ideal for single-shade layering techniques.
The chameleon effect can be seen by applying KALORE to the center of corresponding Vita®† classical shade guide fingers (Fig. 28). Figure 28. Chameleon effect of KALORE Universal shades applied to different Vita®† shades. Figure 29. Difference in opacity between Universal A3 and Opaque A3. 7.3 Opaque Shades KALORE Opaque shades are available as AO2, AO3, AO4, OBW and XOBW.
Figure 30. Class IV cavity restored with differing shades. AO3, A3 and NT on left side, AO3 and A3 on right side. The application of CVT will increase the vividness of Class V restorations significantly (Fig. 31). Figure 31. Class V restorations with cervical shading. CV on left side, CV and CT on right side.
7.5 Chameleon Properties Figure 32b. Reflection of a natural tooth. KALORE offers excellent chameleon properties due to the different interfaces within the material. These result in optical properties and light reflection that are similar to tooth structure (Fig. 32) and enable single and multi-shade restorations with unrivaled esthetics (Fig. 33). Reflection by enamel crystals Reflection by dentin enamel junction Reflection by peritubular dentin Reflection by dentinal tubules Enamel Figure 32a.
7.6 Shade Guide Figure 34. KALORE shade guide. KALORE shades are linked to the Vita®† Classical shade guide. For shade matching with KALORE, the body section is the most representative part of this guide. However, several translucent shades are custom made and require use of the KALORE shade guide. The individual shade samples increase in thickness to enable the clinician to judge the influence of thickness of the composite layer on the shade (Fig. 34). 7.
Existing Users of GC Composite Materials The tables below show the shade ranges available for the composite materials available through GC America. Table 8a. Standard / universal shades. Standard / Universal Shades A1 A2 A3 A3.
Main differences between GC KALORE and GRADIA DIRECT shades 1. Changes in terminology: • Universal shades versus Standard shades. • Opaque shades versus Inside special. • Translucent shades versus Outside special. 2. Changes in bleach shades: • KALORE shades OBW and OXBW are same as GRADIA DIRECT BW and XBW shades. • KALORE BW and XBW are new universal bleach shades with no equivalent GRADIA DIRECT shade. 3. Change in C2 and D2: • KALORE C2 and D2 have a translucency similar to the other Universal shades.
9.0 Clinical investigations Post-operative sensitivity and other clinical parameters of Class II made with KALORE resin composite after one year of clinical service. Ferrari M, Cagidiaco MC, Chazine M., Paragliola R, Grandini S. University of Siena, Italy. Purpose: The aim of this clinical study was to evaluate the post-operative sensitivity and clinical performance of Class II restorations made with KALORE resin composite in combination with G-BOND™.
10.0 Literature 1. 1-year evaluation of Class II made with “KALORE” resin composite. M. Ferrari, M. Cagidiaco, M. Chazine, R. Paragliola and S. Grandini. EADR 2009, abstract 010. 2. Polymerization Shrinkage Ratio and Force of Various Resin Composites. F. Fusejima, S. Kaga, T. Kumagai and T. Sakuma. EADR 2009, abstract 0292. 3. Polymerization Shrinkage Ratio of Various Resin Composites. S. Kaga, F. Fusejima, T. Kumagai, T. Sakuma. IADR 2009, abstract 2441. 4.
12.0 instructions for use GC KALORE LIGHT-CURED RADIOPAQUE UNIVERSAL COMPOSITE RESTORATIVE For use only by a dental professional in the recommended indications. RECOMMENDED INDICATIONS 1. Direct restorative for Class I, II, III, IV, V cavities. 2. Direct restorative for wedge-shaped defects and root surface cavities. 3. Direct restorative for veneers and diastema closure. CONTRAINDICATIONS 1. Pulp capping. 2. In rare cases the product may cause sensitivity in some people.
Note : 1. Material should be placed and light cured in layers. For maximum layer thickness, please consult above table. 2. Lower light intensity may cause insufficient curing or discoloration of the material. 7. Finishing and Polishing Finish and polish using diamond burs, polishing points and discs. To obtain a high gloss, polishing pastes can be used. SHADES 26 Shades 15 Universal Shades (color code on unitip cap / syringe label: green) XBW (Extra Bleaching White), BW (Bleaching White), A1, A2, A3, A3.
13.0 Summary KALORE is a state-of-the-art, direct composite resin designed for anterior and posterior direct restorations. The incorporation of the proprietary monomer DX-511 has enabled optimization of the physical properties of the composite material. KALORE offers reduced polymerization shrinkage and polymerization stress. In laboratory testing, KALORE demonstrated the lowest shrinkage stress of all composites tested.
The following tests were conducted on both sets of samples to confirm the superior performance of KALORE and that the filler particles in KALORE are retained in the matrix: 1. Shrinkage stress test 2. Three-body wear resistance test 3. Combined polish retention/surface roughness test Materials and Methods 1. Shrinkage stress test Setting shrinkage stress was measured in-house using a universal testing machine EZ-S (Shimadzu) with a custom-made jig.
3. Combined polish retention/surface roughness test Composite samples were prepared in an acrylic mold and their surfaces polished using sandpaper with #80, #180, #320, #600, #1000, #1500 and #2000 grits, followed by final polishing with a buff and 1µm alumina. After measuring the surface gloss rates, the samples were moved up and down along a 4 cm path at a rate of 30 strokes per minute and held in indirect contact with an acrylic plate under a load of 350 gf load.
Wear Test Results Wear data was similar for both composite materials tested, despite the fact that the glass and pre-polymerized filler particles in the KALORE without DuPont matrix were disrupted due to shrinkage forces. This can be explained by the protective action of the innovative and newly developed pre-polymerized fillers that are highly loaded with 400 nm glass filler and heat-cured. The relatively high content of pre-polymerized fillers protects the resin effectively against threebody wear.
In another test, the wear resistance of KALORE was compared to a number of other composite materials. Both the wear resistance data and SEM images confirmed that materials with a higher shrinkage stress demonstrate greater particle loss from the matrix, resulting in more wear. Table 3.Three-body wear and shrinkage stress. Three-body wear (µm) Shrinkage Stress (N) (SD) Estelite Quick†, Tokuyama Pre-polymerized Sample broken 10.0 Grandio†, Voco Hybrid 30.2 (9.0) 11.
Combined Polish Retention and Surface Roughness Test Results The initial surface gloss of KALORE without DuPont was lower than for KALORE, and the surface roughness was higher. Since the only difference between the two formulations was the amount of residual stress in the matrix, it was concluded that the inferior properties of KALORE without DuPont are due to greater stress on the particles with a higher risk of filler loss during the polishing procedure.
GC KALORE x2500 CLSM Images Figure 7. CLSM images of KALORE with DuPont matrix after polish retention test. Immediately after polishing retention test. After 100,000 cycles polish. Note that although a slightly rougher surface is observed after the polish retention test, the surface remains smooth. GC KALORE without DuPont x2500 CLSM Images Figure 8. CLSM images of KALORE without DuPont matrix after polish retention test. Immediately after polishing retention test. After 100,000 cycles polish.
Figure 9a. Polymerization shrinkage stress. Large stress on the surface Polymerization Shrink Volume Figure 9b. Polymerization shrinkage stress with KALORE. Less stress on the surface Polymerization Shrink Volume It can be concluded that DX-511, the new low shrinkage monomer, is effective in reducing shrinkage stress as demonstrated by testing of KALORE.
Notes 42 GC Kalore Technical Manual
GC Kalore Technical Manual 43
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