G-ænial Bond from GC technic al manual
Table of Contents 1.0 Introduction 4 2.0 Product description 3.0 Indications for use 4.0 The selective etching technique 4.1 4.2 5.0 5 5 6 Features and benefits 7 6.1 A unique formulation 6.2 The HEMA-free Principle Physical properties – Results of in Vitro Studies 7.1 The mechanisms of adhesion to enamel and dentine 7.2 Bonding performance on dentine 7.3 Bonding performance on enamel 7.
8.0 Summary of Technical Data 9.0 Clinical Study 10.0 Field evaluation 32 33 35 11.0 Technique Guide 38 12.0 Instructions For Use 39 13.
1.0 Introduction The increased popularity of aesthetic dentistry in the last 50 years has driven the need for durable aesthetic restorative materials that provide ease-of-use, give confidence in clinical outcomes and result in patient satisfaction. The advent of adhesive dentistry has made possible the creation of beautiful direct aesthetic restorations using a conservative approach.
The ideal product would deliver high adhesion to enamel whilst being “safe” on dentine, offering the advantages of both techniques. With these objectives in mind, GC has developed G-ænial Bond, a new adhesive system. 2.0 Product description G-ænial Bond is a one component self-etching light-cured adhesive, specially developed for the selective etching approach in which only the enamel is etched prior to application of the selfetching adhesive.
4.2 Why self-etching on dentine? Etching of dentine does not give any additional benefit for bond strength, as demonstrated by the independent studies below. • Microtensile bond strength tested by Professor B. van Meerbeek at the KUL, Leuven, Belgium Figure 1: Microtensile bond strength to dentine (test set up: page 17). Source: Adapted except from Prof B. van Meerbeek, KUL Leuven, Belgium, 2010 Influence of etching on Micro-Tensile Bond Strenght to Dentine significantly different (p> 0.
Disadvantages of etching with phosphoric acid It is now common consensus that phosphoric acid etching of dentine is aggressive, resulting in dentinal tubules that are widely opened, an excessively thick demineralised layer and leaving collagen fibres without any minerals. • Etching of Dentine can result in post-operative sensitivity The major problem in this situation is sealing the dentinal tubules correctly in order to avoid post-operative sensitivity.
5.0 Features and benefits Adopting a dentist oriented approach, GC formulated G-ænial Bond to offer ease of handling and excellent clinical performance of the adhesive. The result is a bonding system providing the following features: • High performance in self-etch and selective etch approaches • High bond strength to dentine • Excellent marginal integrity • Long-term, durable bond • Reduced post-operative sensitivity • Easy handling 6.0 Composition 6.
6.2 The HEMA-free Principle 6.2.1 Why exclude HEMA from the formulation?3 HEMA (2-hydroxyethyl methylmethacrylate) is added to many commercially available adhesives. Adding HEMA provides certain benefits for those products: • Excellent infiltration capacity of up to several millimeters into the etched dentine surface.
6.2.2 Influence of HEMA on bond strength over time In order to assess the long-term durability of the bond and the influence of HEMA, thermocycling tests were performed by GC R&D (2010), comparing the HEMA-free G-ænial Bond to commercially available HEMA-containing adhesive systems. Test set-up: Bovine enamel and dentine samples were embedded in acrylic resin (Unifast III) and polished with #320-grit SiC paper.
Figure 6: Shear bond strength to dentine of the HEMA-free G-ænial Bond (G-a) in comparison to various HEMA-containing bonding materials. Source:GC Corporation, Japan, 2010 Influence of HEMA on Shear Bond Strength to Dentine 35 Shear Bond Strength (MPa) 30 25 20 15 10 5 0 G-a BF EB Dentine OA OF SB+ Dentine after TC The shear bond strength to dentine increased after thermocycling for G-ænial Bond and decreased for all the HEMA containing adhesives.
7.0 Physical properties – Results of in Vitro Studies 7.1 The mechanisms of adhesion to enamel and dentine The adhesion of G-ænial Bond relies on both micro-mechanical retention and chemical bonding principles. 7.1.1 Micro-mechanical interlocking Under aqueous conditions, the two functional monomers (4-MET and phosphoric acid ester) dissolve the smear layer and mildly etch enamel and dentine surfaces, thereby creating microporosities on enamel and increasing the surface available for bonding.
7.1.2 Chemical interaction While micro-mechanical interlocking is hypothesized to be the basis for good adhesion, recent publications have demonstrated that additional chemical interaction between the functional monomers and the tooth substrate could improve the bond durability.4 This is known as the “Adhesion-Decalcification” (or AD) concept. The two functional monomers can form a complex with the remaining calcium salts of the hydroxyapatite crystals, which is the basis for the chemical interaction.
Figure 8: TEM photomicrographs of the dentine/adhesive interface of non-demineralised specimens (x10 000). Hy: Hybrid Layer; Ar: Adhesive resin; D: Dentine. Source: GC Corporation, Japan, 2009 Ar Ar D D G-ænial Bond BOND FORCE D Hy: 1µm D Ar Clearfil SE BOND Hy: 5µm Ar OptiBond FL In the demineralised specimens treated with G-ænial Bond or Clearfil SE Bond (Figure 9 and Figure 10), a nano-interaction zone (NIZ) was observed between the adhesive resin (Ar) and the underlying dentine (D).
Figure 10 demonstrated the higher density of hydroxyapatite crystals within the approximately 500 nm wide NIZ of G-ænial Bond. Figure 10: TEM photomicrographs of the dentine/adhesive interface of demineralised specimens (x 50000) HAp: hydroxyapatite; Ar: Adhesive resin; D: Dentine. Source: GC Corporation, Japan, 2009 D Ar HAp No HAp D Ar G-aenial Bond BOND FORCE D D No HAp HAp Ar Ar Clearfil SE BOND OptiBond FL Bond Force, Clearfil SE Bond and OptiBond FL are not registered trademarks of GC.
7.2 Bonding performance on dentine G-ænial Bond is designed for use of the self-etch approach on dentine, meaning that no phosphoric acid etching agent is used prior to application of the adhesive. The bond strength to dentine is optimal in the self-etch mode. In order to confirm the bonding performance of the adhesive layer observed on the SEM and TEM images, shear bond strength (SBS) and microtensile bond strength (µTBS) tests were conducted internally and externally.
Within the limitations of this test, G-ænial Bond demonstrates a shear bond strength to dentine higher or equal to the tested group, with the exception of three bonding systems (Optibond Solo Plus, Adper Easy Bond and Optibond All-in-one) which yielded higher results. Compared to the two reference standards in their respective categories (Clearfil SE Bond and Optibond FL), G-ænial Bond performed equally well. G-ænial Bond demonstrates excellent bonding to dentine using the self-etch technique. 7.2.
Shear Bond Strength to Dentine Tests performed by M. Derbanne, S. Le Goff and M. Degrange†, Paris, France Another in vitro study conducted by Mathieu Derbanne, Stéphane Le Goff and Michel Degrange†, University of Paris Descartes, France, evaluated the early bond strength to dentine of G-ænial Bond using either the self-etch or the etch-and-rinse technique. Test set-up: Samples were prepared from human 3rd molars and split into 2 groups.
Shear Bond Strength to Dentine after Thermocycling Tests performed by GC R&D, Japan Etched and unetched samples were stored in water and a shear bond strength (SBS) test was conducted at 24 hours after 20 000 cycles of thermocycling (Etch +group only). Test set-up: Bovine dentine specimens were polished with 320-grit SiC paper. For the Etch(+) group, etching was conducted for 10 seconds with a 37% phosphoric acid etching gel (Link Master Etchant, GC). No etching agent was apply to the Etch (-) surfaces.
7.2.3 Qualitative influence of etching on bond strength to dentine The following tests were performed to further assess the influence of etching on the quality of the dentine-adhesive interface and its potential for chemical adhesion. SEM observation of failure modes in dentine Tests performed by M. Derbanne, S. Le Goff and M.
Figure 16: Fracture surface, G-ænial Bond, self-etch, dentine. Source: Adapted excerpt from Prof. M. Degrange†, Univeristy Paris Descartes, France, 2010 G-ænial Bond, self-etch G-ænial Bond, self-etch The fractured surfaces of the self-etched sample show good impregnation into the superficial dentine. The failures observed at the interface are located between the hybrid layer and the bonding layer.
TEM observations on dentine Test performed by GC R&D, Japan In order to better understand the influence of etching on the adhesion mechanism to dentine, interfaces of G-ænial Bond with dentine prepared with and without prior acid etching were examined using TEM by GC R&D. Test set-up: Bovine dentine specimens were polished with 320-grit SiC paper. For the Etch(+) group etching was conducted for 10 seconds with a 37% phosphoric acid etching gel (LINK MASTER ETCHANT, GC).
7.2.4 Influence of surface roughness on bond strength to dentine Shear bond strength to dentine Tests performed by GC R&D, Japan The following test was performed in order to assess the potential influence of surface roughness in bur cut dentine on shear bond strength. Test set-up: Bovine teeth were embedded in acrylic resin (Unifast III) and the exposed enamel and dentine surfaces were polished with #180, 320 and 600 grit SiC paper respectively. G-ænial Bond was applied on the surface of the samples.
7.3 Bonding performance on enamel G-ænial Bond has been designed for use in the selective and self-etch techniques. To confirm the bonding performance of G-ænial Bond on enamel, the following tests were performed. 7.3.
7.3.2 Influence of etching on bond strength to enamel While G-ænial Bond demonstrates good bonding values to enamel, etching of the enamel is preferred if the surface to which the adhesive will be applied consists mainly of enamel rather than dentin, and particularly if the surface consists of intact (uncut) enamel.
Shear bond strength to enamel Tests performed by GC R&D, Japan The purpose of the following study was to assess the adhesion properties of G-ænial Bond with and without phosphoric acid etching (AET). The resulting shear bond strength (SBS) tests were conducted at 24 hours and after 2000 cycles of thermocycling. Test set-up: Bovine enamel specimens were polished with 320-grit SiC paper.
7.3.3 Influence of surface roughness on bond strength to enamel Shear bond strength to enamel Tests performed by GC R&D, Japan The test described below was conducted to assess the influence of bur cut-induced surface roughness on shear bond strength. Test set-up: Bovine teeth were embedded in acrylic resin (Unifast III) and the exposed enamel and dentine surfaces were polished with #180, 320 and 600 grit SiC paper respectively. G-ænial Bond was then applied on the surface.
7.4 Quantitative marginal analysis In order to assess the quality of restorations bonded with G-ænial Bond, using the self-etch and selective etching (etch-and-rinse of enamel) techniques, quantitative marginal analyses were conducted by Dr Uwe Blunck - Charité Universitätsmedizin Berlin, for both Class V and Class I restorations. (2008 & 2010) Test set-up: • Standardised Class V or I preparations were made in extracted human teeth stored in 0.5 % chloramine-T solution (8 per group).
Self-etch technique: Class V The study followed the test set-up as defined page 28: • Standardised Class V preparations were made in extracted incisors (8 per group). • The adhesive system GBA 400 (commercially available as G-ænial Bond) was applied in combination with GC Gradia Direct Posterior according to the manufacturer’s instructions.
Conclusion of the Class V study Within the limitations of this study, the adaptation of G-ænial Bond in class V preparations has proven to be very effective using either the self-etch or the etch-and-rinse technique, independent of the composite used. It is therefore expected that the long-term marginal adaptation of G-ænial Bond restorations will also be very effective under similar clinical conditions. 7.4.
Etch-and-rinse technique, Class I The study followed the test set-up as defined on page 28 • Eight Class I preparations per group were prepared and filled in extracted human molars • After phosphoric-acid etching of the enamel and dentine portions of the preparations for 10 seconds with 37% phosphoric acid (Omni-Etch, Omnident), the preparations were filled with G-ænial Bond in combination with either GC Gradia Direct Posterior, GC G-ænial Posterior, GC Kalore or Filtek Z250 (3M ESPE) using an incremental t
8.0 Summary of Technical Data Etching has proven to provide higher bond strength to enamel but has no added value for dentine, as shown by test results. Thus, etching of dentine is not recommended. However, the selective etching approach is very safe with G-ænial Bond. Test results have shown that there is no decrease in bond strength to etched dentine; therefore, there is no adverse effect if the etchant inadvertently reaches the dentine while etching the enamel.
9.0 Clinical Study 9.1 Class V Clinical Study Study conducted by Professor M. Ferrari, University Siena, Italy Purpose: Post-operative sensitivity is a common complication when Class V restorations are placed on vital teeth. The aim of the first part of this prospective clinical trial was to evaluate the early post-operative sensitivity of Class V restorations placed using GBA 400, available commercially under the brand name G-ænial Bond, in combination with Gradia Direct LoFlo.
9.2 Class II Clinical Study Study conducted by Professor M. Ferrari, University Siena, Italy Purpose: The aim of this clinical study was to evaluate the post-operative sensitivity and clinical performance of Class II restorations placed using GBA 400, commercially available under the brand name G-ænial Bond, in combination GDLS-200 resin composite, commercially available under the brand name Kalore. Materials and methods: Patients were selected who required at least one and no more than two restorations.
10.0 Field evaluation Thirty dentists from all over Europe tested G-ænial Bond in 2010, placing in total almost 800 restorations. Most of the dentists were using different bonding systems in their surgeries. Figure 29: Number of restorations in each indication type How many restorations did you place with the trial material? 250 204 201 200 G-ænial Bond was used to restore all types of preparations. In total, almost 800 restorations were placed.
10.2 Handling Results G-ænial Bond has been designed to require only a very limited number of application steps, thereby offering ease and simplicity of use and avoiding the risk of errors during application. The bottle dispenser, viscosity, and the surface appearance were all designed to fulfil these objectives. Figure 31: Evaluation of the viscosity of G-ænial Bond 93% of users found the viscosity of the product appropriate.
10.3 Post-operative sensitivity Figure 33: Incidence of post-operative sensitivity Did your patients experience any post-operative sensitivity? 100% 90% 87% 80% 70% 60% 50% 40% 30% One of the major reasons for using a self-etching adhesive is to ensure a low incidence of post-operative sensitivity. Even though etching of the enamel was often performed which could have led to some inadvertent etching of dentine very few cases of post-operative sensitivity were reported.
11.0 Technique Guide The application of G-ænial Bond requires only a very limited number of steps: In self-etch mode Application Waiting 10 sec. Drying 5 sec. with max air Light-curing In selective etch mode Phosphoric acid applica- Rinsing Drying tion for 10s on enamel only Application of bonding Waiting 10 sec agent to the entire area 38 G-ænial Bond Technical Manual Drying 5 sec.
12.0 Instructions For Use G-ænial Bond ONE COMPONENT SELF-ETCHING LIGHT-CURED ADHESIVE For use only by a dental professional in the recommended indications. Recommended Indications 1. Bonding of light-cured composites and acid-modified composites (compomers) to tooth structure. 2. Bonding of dual-cured luting and core build-up composites to tooth structure, provided these materials are light-cured. Contraindications 1. Pulp capping. 2. In rare cases, this product may cause sensitivity.
b) IMMEDIATELY apply to the prepared enamel and dentine surfaces using the disposable applicator (Fig. 4). c) Leave undisturbed for 10 seconds after applying (Fig.5). d) Then, dry thoroughly for 5 seconds with oil-free air under MAXIMUM air pressure. Use vacuum suction to prevent splatter of the adhesive (Fig. 6). The final result should be a thin adhesive film with the Fig. 4 appearance of frosted glass and that does not visibly move under further air pressure.
Storage Store at room temperature (1-28°C) (33.8-82.4°F). If not in use for a prolonged period of time, store in refrigerator. Shelf life: 2 years from date of manufacture. Package 1. G-ænial Bond Bottle Kit: 5 mL liquid (1), disposable dispensing dish (20), disposable applicator fine (50) 2. G-ænial Bond Bottle Refill: 5 mL liquid (1) 3. G-ænial Bond 3-bottle Pack: 5 mL liquid (3) Caution 1. G-ænial Bond is flammable. Do not use near naked flame. Keep away from sources of ignition.
13.0 Literature references 1. Adhesive Properties of New All-in-one Adhesive, GC G-BOND PLUS. A. Arita, T. Kimura, T. Kumagai and T. Sakuma. Abstract 1802 – IADR 2009 Miami, USA 2. Vertical and Horizontal Setting Shrinkages in Composite Restorations. M. Irie, Y. Tamada, Y. Maruo, G. Nishigawa, M. Oka, S. Minagi, K. Suzuki and D. Watts. Abstract 2443 – IADR 2009 Miami, USA 3. Influence of composite resin on bond strength of all-in-one adhesives. C. Goracci, M. Margvelashvili, M. Sedda, E. Magni and M.
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