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Clinical evaluation of EBS dentine bonding agent:one year results

2000, Australian Dental Journal

There are numerous dentine bonding agents c u r r e n t l y on the market, the majority of which adhere by means of infiltration of a hydrophilic p o l y m e r i z a b l e diacrylate into dentinal collagen exposed by acid treatment. The purpose of the present study was to evaluate the clinical performance of one such product, EBS dentine bonding, in nonundercut caries-free cervical lesions. Forty cavities were restored in eight patients of mean age 53 years. The manufacturer's instructions were followed, which involved essentially etching the enamel and dentine for 20 seconds with 32 per cent phosphoric acid, application and evaporation of EBS Primer, followed by placement and curing of EBS Bond, and restoring the cavity with Pertac II (ESPE) hybrid resin composite. Restorations were photographed at base line and one year for evaluation of marginal discolouration on a continuous linear rating scale. A t six months, one patient with four restorations was not available; the remaining 36 restorations were all present. At one year, one restoration was missing, giving a cumulative retention rate of over 97 per cent. One of the 36 restorations exhibited very mild marginal discolouration.

SCIENTIFIC A R T I C L E Australian Dental Journal 2000;45:(2):115-117 Clinical evaluation of EBS dentine bonding agent:one year results Martin J Tyas,* Michael F Burrow† Abstract There are numerous dentine bonding agents currently on the market, the majority of which adhere by means of infiltration of a hydrophilic polymerizable diacrylate into dentinal collagen exposed by acid treatment. The purpose of the present study was to evaluate the clinical performance of one such product, EBS dentine bonding, in nonundercut caries-free cervical lesions. Forty cavities were restored in eight patients of mean age 53 years. The manufacturer’s instructions were followed, which involved essentially etching the enamel and dentine for 20 seconds with 32 per cent phosphoric acid, application and evaporation of EBS Primer, followed by placement and curing of EBS Bond, and restoring the cavity with Pertac II (ESPE) hybrid resin composite. Restorations were photographed at base line and one year for evaluation of marginal discolouration on a continuous linear rating scale. At six months, one patient with four restorations was not available; the remaining 36 restorations were all present. At one year, one restoration was missing, giving a cumulative retention rate of over 97 per cent. One of the 36 restorations exhibited very mild marginal discolouration. Key words: Dental bonding, dentine bonding agents, acid etching, tooth abrasion therapy. (Received for publication October 1999. Revised January 2000. Accepted February 2000.) Introduction The bonding of resin composite to enamel is now a well established clinical procedure, achieved by treating the enamel with acid,commonly 32 per cent phosphoric acid, which selectively etches either the prisms or the interprismatic substance to leave a high energy, porous surface. Bonding of resin composite to dentine is much more challenging, due to its heterogeneous, low energy and relatively wet nature.1 The early dentine bonding agents were designed to bond chemically to the dentine,2 but this *Reader, School of Dental Science,The University of Melbourne. †Senior Lecturer, School of Dental Science, The University of Melbourne. Australian Dental Journal 2000;45:2. did not occur in practice and clinical failure rates were high in non-undercut non-carious cervical lesions.3 Following the work of Nakabayashi et al.,4 almost all the current dentine bonding agents achieve adhesion mechanically by infiltration into the dentinal collagen, exposed by acid treatment of the dentine, by a hydrophilic polymerizable monomer (a ‘primer’). The infiltrated collagen is termed the ‘ hy b ri d ’ or ‘resin-reinforced’ layer, and the methacrylate groups on its surface can then bond chemically to the subsequently placed resin composite, assisted by an intermediate layer of ‘adhesive’ or ‘bond’ which acts as a wetting agent.2 Commercial products commonly employ simultaneous enamel and dentine etching, in order to enhance the efficiency of the bonding procedure. One such material is EBS (ESPE Dental AG, Seefeld, Germany).The etch consists of 32 per cent phosphoric acid, the Primer is an aqueous solution of hydroxyethylmethacrylate (HEMA) and methacryl magnesium chelate (MMC), and the Bond is malonic acid alkyl methacrylate (MAM) and bis-methacrylates. There are limited published data on EBS. A tensile bond strength of 9.8 MPa,5 and shear bond strengths of 17.2 MPa5 and 33.6 MPa,6 have been reported. In a clinical study, van Dijken7 reported a zero one year loss rate of zero for Pertac (ESPE Dental AG, Seefeld, Germany) resin composite restorations bonded with EBS in noncarious cervical lesions (NCCL). However, this appears to be the only study of this type available. The purpose of the present study was to evaluate the clinical performance, with respect to retention and marginal discolouration, of the EBS bonding system in NCCLs, using Pertac II as the resin composite. The data can then be used to assess the external validity of van Dijken’s study7 and to confirm the efficacy of the chemistry of the system. Materials and methods Eight patients (age range 24-75 years; mean age 53 years) gave informed consent for inclusion in the 115 study. Forty teeth were restored according to the manufacturer’s instructions: 1 upper molar; 8 upper premolars; 7 upper anteriors; 2 lower molars; 15 lower premolars; 7 lower anteriors. The teeth were cleaned for a few seconds with a pumice/water slur ry on a rubber cup at slow speed, then washed and dried. Etching gel was applied to the cavity and surrounding tooth structure for 20 seconds and washed off with a copious air/water spray. The cavity was dried with oil-free air and the EBS Primer (B/N 002) applied for 20 seconds with a scrubbing action with the sponge-ended applicator supplied.The (water) solvent was evaporated by air, and EBS Bond (B/N 022) applied in the same way as the Primer, followed by gentle air-thinning and photopolymerization for 20 seconds. Pertac II resin composite was applied in a single increment, photocured, and the final restoration polished using fine diamonds and Soflex discs (3M Dental Products, St Paul, MN, USA). Restorations were photographed on colour slide film for evaluation of marginal discolouration on a continuous linear rating scale of zero to eight against a standard set of photographs.8 Patients were recalled at six months and one year for evaluation of r e s t o r ation integrity and for photographs for assessment of marginal discolouration. Results At six months all examined restorations were present, however, one patient with four restorations was lost to the study.The retention rate, using survival analysis, was therefore 100 per cent.At one year,one restoration was missing from an upper right canine, giving a retention rate of 97.7 per cent. At six months no marginal discolouration was visible. At one year one restoration exhibited a score of 2 for marginal discolouration, that is, it was clinically hardly detectable. Discussion The two published bond strength values of EBS5,6 are widely different at 17.2 MPa and 33.6 MPa .T h e disparity between bond strength measurements of the same material in different laboratories has been discussed previously9 and is inherent in dentine bond strength testing. In any case, laboratory bond strength may not be indicative of clinical performance.10 EBS is claimed to bond to dentine by diffusion of the primer into the collagen to form a hybrid layer, facilitated by the HEMA, which is water soluble and polymerizable, and this has been observed on s c a n n i n g electron micrographs. 6 However, the manufacturers also suggest that the additional component in the EBS Primer,methacryl magnesium chelate, may react with dentinal calcium to form 116 methacryl calcium chelate, and thus some chemical bonding may also occur. This possibility does not appear to have been confirmed analytically. The study reported here is essentially a pilot study, based on a relatively small number of restorations. No attempt was made to select teeth or patients based on specific criteria, and the design of the study is therefore analogous to the way the materials might be used in a general practice. The effectiveness of the bond is demonstrated clinically by the high retention rate in NCCLs, which were non-undercut, and thus restoration retention depended mainly on the adhesive efficacy of the EBS.The one year retention rate of over 97 per cent is in agreement with that of van Dijken,7 who reported a 100 per cent retention rate of the 52 EBS/Pertac restorations in his study. The single restoration which showed slight marginal discolouration in the present study may be a result of a technique failure, for example, inadequate etching of the enamel or excessive drying of the Primer. If there was a fundamental problem with the material, more restorations would probably have been affected. Thus,the results of this study contribute to the external validity of van Dijken’s study,7 and the two studies together, involving the restoration of 92 NCCLs, confirm the good clinical performance of EBS. There is currently a trend towards so-called ‘onebottle’ systems, although this is strictly incorrect as almost all products only combine primer and adhesive (bond) into one bottle and still require a separate etch.There are some advantages of using a ‘one-bottle’ system, such as simplified stock control and infection control, but the total time taken for the bonding procedure is not necessarily less than that for a ‘two-bottle’ system.11,12 The main issue concerning EBS (a ‘two-bottle’ system) is that each cavity must be scrubbed for 20 seconds with the Primer and for 20 seconds with the Bond. The basis for a 20 second scrub is the bond strength data of May,13 who reported a tensile bond strength of 9.6 MPa when the Primer was left undisturbed on the dentine for 60 seconds, and 11.4 MPa when the dentine was ‘scrubbed’ with the Primer for 20 seconds. These values were not significantly different; however, when restoring one tooth, the scrubbing technique would save 40 seconds. Conversely, if there were more than three cavities being restored simultaneously, the individual scrubbing technique would take longer overall than passive placement. The manufacturer should therefore consider allowing the option of a 60 second passive Primer application, as well as a 20 second scrub. EBS has now been superseded by EBS-Multi. The components of EBS-Multi are the same as those of EBS, except that part of a self-cure polymerization initiator is included in the Primer. This self-cure Australian Dental Journal 2000;45:2. initiator has no function when EBS-Multi is used with a photocured resin composite, but is important when used with a resin luting cement (Compolute; ESPE Dental AG, Seefeld,Germany). When used in the adhesive restoration of non-carious cervical lesions, the performance of EBS-Multi would be expected to be no different from that of EBS. Acknowledgement This study was supported by ESPE Dental AG, Seefeld, Germany. References 1. Douglas WH. Clinical status of dentine bonding agents. J Dent 1989;17:209-215. 2. Eick JD, Gwinnett AJ, Pashley DH, Robinson SJ. Current concepts on adhesion to dentin. Crit Rev Oral Biol Med 1997;8:306-335. 3. Tyas MJ. Clinical testing – has it proved the efficacy of adhesives? Int Dent J 1993;43:343-347. 4. Nakabayashi N, Nakamura M, Yasuda N. Hybrid layer as a dentin-bonding mechanism. J Esthet Dent 1991;3:133-138. 5. May KN, Swift JR, Bayne SC. Bond strengths of a new dentin adhesive system. Am J Dent 1997;10:195-198. 6. El Kalla IH, Garcia-Godoy F. Bond strength and interfacial micromorphology of four adhesive systems in primary and permanent molars. J Dent Child 1998;65:169-176. Australian Dental Journal 2000;45:2. 7 . van Dijken JWV. Clinical effectiveness of nine dentin adhesives in Class V cervical lesions. J Dent Res 1997;76:185: Abstr 1369. 8. Tyas MJ, Burns GA, Byrne PF, Cunningham PJ, Dobson BC,Widdop FT. Clinical evaluation of Scotchbond:one-year results. Aust Dent J 1986;31:159-164. 9. Øilo G, Olsson S. Tensile bond strength of dentin adhesives: a comparison of materials and methods. Dent Mater 1990;6:138-144. 10. Finger WJ. Dentin bonding agents. Relevance of in vitro investigations. Am J Dent 1988;1:184-188. 11. Clinical Research Associates. Dentin-resin adhesion, newest systems. CRA Newsletter 1996;20:1-3. 12. Clinical Research Associates. Dentin-resin adhesion, 5 newest products. CRA Newsletter 1997;21:1-2. 13. May R. Dentin tensile bond strength: effect of different primer application. J Dent Res 1998;77:638: Abstr 50. Address for correspondence/reprints: Associate Professor Martin J. Tyas, School of Dental Science, The University of Melbourne, 711 Elizabeth Street, Melbourne,Victoria 3000 117