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van Dijken et al Fig 1 Relative cumulative loss rates (%) of the Xeno III bonding system in combination with the two restorative materials (Tetric Ceram, Dyract AP). vical lesions. The hypothesis tested was that the polyacid resin-modified resin composite would show better clinical retention. MATERIALS AND METHODS A total of 133 Class V restorations were placed in 57 patients (32 men and 25 women) with a mean age of 61.5 years (range 43 to 84), for whom treatment of noncarious cervical lesions was indicated. All restorations were placed in dentin lesions without any intentional enamel involvement, by one experienced operator familiar with adhesive dentistry. Fortyfour restorations were placed in anterior teeth, 55 in premolars and 32 in molars. Fifty-nine restorations were made in the maxillary arch and 74 in the mandibular. A single-step self-etching primer (Xeno III, Dentsply/DeTrey; Konstanz, Germany; lot nr 0206001237) was evaluated in combination with two different restorative resinous materials, a hybrid resin composite (Tetric Ceram, Ivoclar/Vivadent; Schaan, Liechtenstein; lot E17820) and a polyacid-modified resin composite (Dyract AP, Dentsply/DeTrey; batch nr 0203001190). Liquid A of the two-part adhesive system contains water, ethanol, HEMA, UDMA and BHT (2,6-di-tertbutyl-p hydroxyl toluene) and nanofiller. Liquid B contains UDMA, CQ, EPD (p-dimethylaminoethyl benzoate) and two patented monomers Pyro-EMA (tetramethacryloxyethyl pyrophosphate and PEM-F (pentamethacryloxyethyl cyclophosphazene monofluoride). The operative field was isolated with cotton rolls and a saliva suction device. Before conditioning, the lesions were cleaned of plaque and/or saliva if necessary. The adjacent gingiva was retracted by gingival retraction instruments or matrix bands when necessary to secure unrestricted contamination-free access to the field. No bevel was placed. Application of the primer was performed according to the manufacturers’ instructions. After mixing, the primer was applied for 20 s, carefully air dried for some seconds to remove the solvent, taking care not to thin the primer layer. The layer was then light cured for at least 10 s (Astralis 7, HP curing mode; Ivoclar/Vivadent). Sixty-five restorations were made at random with the polyacid resin-modified resin composite and 68 with a high-viscosity resin composite restorative material. The restoratives were applied in most cases in two increments using selected composite instruments (Hu Friedy; Leimen, Germany) and light cured. All participants were informed about the material and the follow-up evaluations according to the rules at the Dental School Umeå. The restorations were evaluated at 6, 12, 18, and 24 months using slightly modified USPHS criteria. 3,5 Only the retention evaluations are reported here. Postoperative sensitivity was registered. Descriptive statistics were used to present the results. Cumulative retention failures were calculated by dividing the number of lost restorations at the recalls by the total number evaluated at the respective recall. Differences in distribution of the ratings between the adhesive systems for the investigated variables were statistically analyzed with the binomial test for independent samples and intraindividual comparisons of the 2 materials with Friedman’s two-way analysis of variance. 13 RESULTS At the end of the follow-up, 130 restorations could be evaluated. One patient with three restorations was not able to attend the 2-year recall. No recurrent caries was observed or postoperative sensitivity reported. Ten lost restorations (7.7%) were observed during the 2-year follow-up, resulting in relative cumulative failure frequencies for all restorations at 6, 12, 18, and 24 months of 0.8%, 3.1%, 6.9%, and 7.7%, respectively. The failure frequencies for the restorations with Tetric Ceram at the four evaluations were 0%, 0%, 5.9%, and 7.4%, and for Dyract AP restorations 1.6%, 6.5%, 8.1%, and 8.1%, respectively; the differences were not statistically significant (Fig 1). 242 The Journal of Adhesive Dentistry
van Dijken et al DISCUSSION The rapid progression of adhesive materials during the last 20 years has resulted in a situation where many adhesive systems have been replaced by modified successors which were claimed to be better without clinical validation. Clinical trials have been limited in number since they require several years of regular recalls. Enamel-resin bonds produced after acid etching with phosphoric acid have proven satisfactory and stable over time. 2,5,6 Adhesion to dentin, on the other hand, has been difficult to achieve because of the substrate’s wet nature. The efficacy of dentin bonding can be demonstrated in cervical abrasion/erosion lesions without involvement of the contiguous enamel. These surfaces are ideal to test clinical dentin bonding because they are widely available. 12 Therefore, no enamel bevel was made in the study and care was taken not to involve the enamel surface contiguous with the lesions during the etching-priming step. However, many of the lesions still contained a small enamel margin in the incisal area, and the evaluation of clinical retention to only dentin tissue was therefore not 100%. At the end of the two years, the recall rate was high (130/133). The retention rate for the adhesive system was 92.3%. Türkün recently reported a 96% retention rate after one year for the same adhesive. 16 For provisional acceptance, the latest guidelines of the American Dental Association (Dental and enamel adhesive materials: ADA, Council on Dental Materials, Instruments, and Equipment, 1994) for submission of dentin and enamel adhesive materials require that no more than 5% of the restorations have been lost and not more than 5% of the restorations may show microleakage at the 6-month recall. To obtain full acceptance, the cumulative incidence of clinical failures in each of two independent clinical studies has to be lower than 10% lost restorations and 10% microleakage after 18 months. The dentin retention rates for the tested adhesive were 3.1% and 6.9% at 6 and 18 months, respectively, fulfilling the ADA guidelines for enamel-dentin adhesive systems. There were no significant differences in clinical retention rates between the restorations placed with the resin composite or the polyacid-modified resin composite. The hypothesis was therefore not accepted. Kemp-Scholte et al 8 showed that materials with lower elasticity modulus can act as an elastic buffer, which relieved contraction stresses and improved marginal integrity. Since most polyacid-modified resin composites include resins with a modulus of elasticity value between those of resin composite and glass-ionomer cement, these materials may work as a stress-breaking barrier between the tooth and the composite. 1 A significantly better adaptation was observed with the SEM replica technique for a polyacid-modified resin composite/resin composite sandwich technique compared to resin composite only restorations. 9 However, the same authors could not show any clinical evidence for the interfacial adaptation results observed by SEM. No significant statistical or clinical differences were observed between the two techniques during 3- and 9-year periods. 10,11 The polyacid-modified resin composite tested in the present study has a modulus of elasticity value close to that of resin composite materials, which may partly explain why no differences were observed (personal communication, E. Asmussen). CONCLUSION It can be concluded that the single-step self-etching adhesive showed acceptable clinical retention rates during the evaluation period, independent of restorative material used. ACKNOWLEDGMENTS This study was supported in part by the County Council of Västerbotten and Dentsply DeTrey, Konstanz, Germany. REFERENCES 1. Attin T, Vataschki M, Hellwig E. Properties of resin-modified glass-ionomer restorative materials and two polyacid-modified resin composite materials. Quintessence Int 1996;27:203-209. 2. de Munck J, van Landuyt K, Peumans M, Poitevin A, Lambrechts P, Braem M, van Meerbeek B. A critical review of the durability of adhesion to tooth tissue: methods and results. J Dent Res 2005;84:118-132. 3. Dijken van JWV. A clincial evaluation of anterior conventional, microfiller and hybrid composite resin fillings. A six year follow up study. Acta Odont Scand 1986;44:357-367. 4. Dijken van JWV. Multi-step versus simplified enamel-dentin bonding systems- Réalités Cliniques 1999;10:199-222. 5. Dijken van JWV. Durability of new restorative materials in Class III cavities. J Adhes Dent 2001;3:65-70. 6. Frankenberger R, Krämer N, Petschelt A. Long term effect of dentin primers on enamel bond strength and marginal adaptation. Oper Dent 2000;25:11- 19. 7. Gernhardt CR, Biesecke G, Schaller HG. Tensile bond strength of a self-conditioning dentin adhesive system in vitro [abstract 338]. J Dent Res 2003;82:B 55. 8. Kemp-Scholte CM, Davidson CL. Marginal integrity related to bond strength and strain capacity of composite resin restorative systems. J Prosth Dent 1990;64:658-664. 9. Lindberg A, Dijken van JWV, Hörstedt P. Interfacial adaptation of a Class II polyacid-modified resin composite/ resin composite laminate restoration in vivo. Acta Odont Scand 2000;58:77-84. 10. Lindberg A, van Dijken JWV, Lindberg M. A 3-year evaluation of a new open sandwich technique in class II cavities. Am J Dent 2003;15:33-36. 11. Lindberg A, van Dijken JWV, Lindberg M. 9-year evaluation of a poly-acid-modified resin composite open sandwich technique in class II cavities. J Dent 2007;35:124-129. 12. Peumans M, Kanumilli P, De Munck J, van Landuyt K, Lambrechts P, van Meerbeek B. Clinical effectiveness of contemporary adhesives: A systematic review of current clinical trials. Dent Mater 2005;21:864-881. 13. Siegel S. Nonparametric Statistics. New York: McGraw-Hill, 1956. 14. Tay FR, Pashley DH. Water-treeing – a potential mechanism for degradation of dentin adhesives. Am J Dent 2003;16:6-12. 15. Tay FR, Pashley DH, Yiu CKY, Sanares AME, Wei SHY. Factors contributing to the incompatibility between simplified-step adhesives and self-cured or dualcured composites. Part I. Single-step self-etch adhesive. J Adhes Dent 2003;5:27-40. 16. Türkün LS. The clinical performance of one- and two-step self-etching adhesive systems at one year. J Am Dent Assoc 2005;136:656-664. Clinical relevance: The adhesive showed a good clinical performance during the 2 year follow-up in noncarious cervical lesions. Vol 9, Supplement 2, 2007 243
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