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dental materials 24 ( 2 0 0 8 ) 915–922 available at www.sciencedirect.com journal homepage: www.intl.elsevierhealth.com/journals/dema Long-term dentin retention of etch-and-rinse and self-etch adhesives and a resin-modified glass ionomer cement in non-carious cervical lesions Jan W.V. van Dijken a,, Ulla Pallesen b a Department of Odontology, Ume˚ a University, Ume˚ a, Sweden b Department of Cariology and Endodontics, School of Dentistry, Faculty of Health Science, University of Copenhagen, Denmark article info Article history: Received 1 March 2007 Accepted 11 November 2007 Keywords: Adhesion Clinical Dental material Etch Glass ionomer Resin Restoration Self-etch abstract Objectives. The aim of this study was to evaluate the clinical long-term retention to dentin of seven adhesive systems. Methods. A total of 270 Class V restorations of four etch-and-rinse, one self-etch adhesive sys- tem and a resin-modified glass ionomer cement were placed in non-carious cervical lesions without intentional enamel involvement. The restorations were evaluated at baseline, 6, 12, 18, and 24 months and then every year during a 13-year follow-up. Dentin bonding efficiency was determined by the percentage of lost restorations. Results. During the 13 years, 215 restorations could be evaluated. The cumulative loss rate at 13 years was 53.0%, with significant different failures rates for the different systems varying between 35.6 and 86.8%. Four systems fulfilled the ADA 18-month full acceptance retention criteria. Two systems showed at 18 months and earlier high debonding rates. The annual failure rates for the etch-and-rinse systems were Optibond 3.1%, Permagen 13.0%, Scotchbond MP 4.8%, Syntac classic 2.8%; for the self-etch system P&S 4.4%; and the resin-modified glass ionomer cement Vitremer 2.7%. Conclusion. It can be concluded that all systems showed a continuous degradation of the bond with a wide variation, which was independent of the adhesion strategy. Three bond- ing systems showed a cumulative failure rate after 13 years between 36 and 41% with the best retention for the resin-modified glass ionomer cement and a four-step etch-and-rinse system. © 2007 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved. 1. Introduction Most procedures in operative dentistry involve day-to- day adhesive techniques. The introduction of amphiphilic monomers, dissolved in solvents such as water, acetone or alcohol, made the bond to dentin more reliable and improved clinical retention [1–4]. The monomers infiltrate moist dentin Corresponding author. Tel.: +46 90 7856034/226; fax: +46 90 770580. E-mail address: [email protected] (J.W.V. van Dijken). surfaces and create a molecular entanglement network with the collagen fibrils resulting in high micromechanical bonds. The exposed collagen fibrils are susceptible to hydrolytic degradation in the wet oral environment, and reduction of bond strength due to degradation of the resin–dentin bond has been observed in the laboratory and in vivo [5–8]. Clini- cal bonding effectiveness can be demonstrated in non-carious 0109-5641/$ – see front matter © 2007 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.dental.2007.11.008

Long-term dentin retention of etch-and-rinse and self-etch adhesives and a resin-modified glass ionomer cement in non-carious cervical lesions

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Page 1: Long-term dentin retention of etch-and-rinse and self-etch adhesives and a resin-modified glass ionomer cement in non-carious cervical lesions

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d e n t a l m a t e r i a l s 2 4 ( 2 0 0 8 ) 915–922

avai lab le at www.sc iencedi rec t .com

journa l homepage: www. int l .e lsev ierhea l th .com/ journa ls /dema

ong-term dentin retention of etch-and-rinse and self-etchdhesives and a resin-modified glass ionomer cementn non-carious cervical lesions

an W.V. van Dijkena,∗, Ulla Pallesenb

Department of Odontology, Umea University, Umea, SwedenDepartment of Cariology and Endodontics, School of Dentistry, Faculty of Health Science,niversity of Copenhagen, Denmark

r t i c l e i n f o

rticle history:

eceived 1 March 2007

ccepted 11 November 2007

eywords:

dhesion

linical

ental material

tch

lass ionomer

esin

estoration

elf-etch

a b s t r a c t

Objectives. The aim of this study was to evaluate the clinical long-term retention to dentin

of seven adhesive systems.

Methods. A total of 270 Class V restorations of four etch-and-rinse, one self-etch adhesive sys-

tem and a resin-modified glass ionomer cement were placed in non-carious cervical lesions

without intentional enamel involvement. The restorations were evaluated at baseline, 6, 12,

18, and 24 months and then every year during a 13-year follow-up. Dentin bonding efficiency

was determined by the percentage of lost restorations.

Results. During the 13 years, 215 restorations could be evaluated. The cumulative loss rate

at 13 years was 53.0%, with significant different failures rates for the different systems

varying between 35.6 and 86.8%. Four systems fulfilled the ADA 18-month full acceptance

retention criteria. Two systems showed at 18 months and earlier high debonding rates.

The annual failure rates for the etch-and-rinse systems were Optibond 3.1%, Permagen

13.0%, Scotchbond MP 4.8%, Syntac classic 2.8%; for the self-etch system P&S 4.4%; and

the resin-modified glass ionomer cement Vitremer 2.7%.

Conclusion. It can be concluded that all systems showed a continuous degradation of the

bond with a wide variation, which was independent of the adhesion strategy. Three bond-

ing systems showed a cumulative failure rate after 13 years between 36 and 41% with the

best retention for the resin-modified glass ionomer cement and a four-step etch-and-rinse

system.

emy

degradation in the wet oral environment, and reduction of

© 2007 Acad

. Introduction

ost procedures in operative dentistry involve day-to-ay adhesive techniques. The introduction of amphiphilic

onomers, dissolved in solvents such as water, acetone or

lcohol, made the bond to dentin more reliable and improvedlinical retention [1–4]. The monomers infiltrate moist dentin

∗ Corresponding author. Tel.: +46 90 7856034/226; fax: +46 90 770580.E-mail address: [email protected] (J.W.V. van Dijken).

109-5641/$ – see front matter © 2007 Academy of Dental Materials. Puoi:10.1016/j.dental.2007.11.008

of Dental Materials. Published by Elsevier Ltd. All rights reserved.

surfaces and create a molecular entanglement network withthe collagen fibrils resulting in high micromechanical bonds.The exposed collagen fibrils are susceptible to hydrolytic

bond strength due to degradation of the resin–dentin bondhas been observed in the laboratory and in vivo [5–8]. Clini-cal bonding effectiveness can be demonstrated in non-carious

blished by Elsevier Ltd. All rights reserved.

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l s 2 4 ( 2 0 0 8 ) 915–922

Fig. 1 – Cumulative loss rates (%) of the bonding systemstested in Class V non-carious lesions during the 13-year

916 d e n t a l m a t e r i a

cervical lesions located mainly in dentin, in which no cavitypreparation or macro-mechanical retention is used. Unfortu-nately, most of these published trials are of limited durability,and more information about the clinical performance over asignificant period of time is necessary [8,9]. Recently, a largevariation in clinical long-time dentin bonding effectivenesswas shown between adhesive systems, independent of adhe-sion strategy [8]. The purpose of this study was to presentthe long-term clinical effectiveness of four etch-and-rinse, oneself-etch bonding system, and a resin-modified glass ionomercement in non-carious cervical lesions.

2. Materials and methods

A total of 270 Class V restorations were placed in 88 patients(46 men and 42 women) with a mean age of 56.7 years (range28–83), for whom treatment of non-carious cervical lesionswas indicated. All restorations were placed in dentin lesions,without any intentional enamel involvement, by one expe-rienced operator who was familiar with adhesive dentistry.The following adhesive systems were successively investi-gated as they became available in different time periods: threethree-step etch-and-rinse systems: Optibond (n = 44), Perma-gen (n = 41), Scotchbond Multi-Purpose (n = 43); one four-stepetch-and-rinse system: Syntac classic (n = 47); a one-step self-etch system: PSA (n = 46) and a resin-modified glass ionomercement Vitremer (n = 49) (Table 1).

Before conditioning, the lesions were cleaned preopera-tively from plaque and/or saliva if necessary. The adjacentgingiva was retracted by gingival retraction instruments ormatrix bands when necessary to secure unrestricted con-tamination free access to the field [3]. No bevel was placed.Conditioning of the etch-and-rinse system lesions was per-formed by applying phosphoric acid or maleic acid followedby thoroughly water spraying for 20 s, carefully air dryingin order to maintain a moist dentinal surface following thewet-bonding technique to prevent collapse of unsupportedcollagen (Table 1). Applying of adhesives and/or light curingwas performed according to the manufacturers instructions(Table 1). The resin composite materials were applied inat least two increments using a selected resin compositeinstrument (Hu Friedy). The resin-modified glass ionomer wasapplied in bulk and contoured with a slightly wet cotton pellet.Each increment was light cured for 40 s with a light unit, whichwas controlled for good light intensity once a week (Luxor, ICI,Macclesfield, UK; 400 mW/cm2).

The restorations were evaluated at baseline, 6, 12, 18,and 24 months and then at least every year during 13 yearswith regard to retention, marginal adaptation, color match,marginal discoloration, secondary caries and surface rough-ness. Slightly modified USPHS criteria were used [10]. Theclinical bonding effectiveness was determined by the per-centage of lost restorations during the evaluation period.In this study only the retention data, which are relevantfor the long-term evaluation of the bond are given. The

Statistical Package for Social Sciences, Version 14.0 (SPSS,Chicago, USA) was used to process the data. Descriptivestatistics were used to present the results. Cumulative reten-tion failures were calculated by dividing the number of

follow-up.

lost restorations at the recalls by the total number evalu-ated. Differences in distribution of the ratings between theadhesive systems for the investigated variables were statisti-cally analyzed by the binomial test for independent samples[11].

3. Results

During the 13 years, 20 patients with 55 restorations (Opti-bond 12, Permagen 3, Scotchbond Multi-Purpose 6, Syntacclassic 14, PSA 16, Vitremer 4) could not be evaluated at allrecalls due to moving of the patients (22), death (27) or pros-thetic or periodontal reasons (6). At the end of the follow-up,215 restorations could be evaluated. A cumulative numberof 114 restorations (50.3%) was lost during the 13 years. Forthe etch-and-rinse systems Optibond 40.6%, Permagen 86.8%,Scotchbond Multi-Purpose 62.4%, Syntac classic 36.4%, theone-step self-etch system PSA 56.6% and the resin-modifiedglass ionomer cement Vitremer 35.6%. The annual failurerates for the etch-and-rinse systems were Optibond 3.1%, Per-magen 13.0%, Scotchbond MP 4.8%, Syntac classic 2.8%, forthe self-etch system PSA 4.4%, and the resin-modified glassionomer cement Vitremer 2.7%. Significant differences in lossrates were observed between the systems (p < 0.05). The fol-lowing ranking was found between the clinical effectivenessof the systems with the best material mentioned first: Syntacclassic, Optibond, Vitremer > Scotchbond MP, PSA > Permagen.The cumulative loss rates at the recall periods during thefollow-up of the different restorative systems are shown inFig. 1. None of the restorations was replaced because ofrecurrent caries, post-operative sensitivity or esthetic rea-sons.

4. Discussion

Adhesion technology progressed rapidly during the last decen-nium showing improved bond strength in vitro [1,12]. Most

of these bond strength tests are performed directly afterestablishment of the bond. The biomaterial–tooth inter-faces despite good initial bond strength are subjected tomechanical as well as chemical degradation. In the oral envi-
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d e n t a l m a t e r i a l s 2 4 ( 2 0 0 8 ) 915–922 917

Table 1 – Composition and handling of the bonding systems

Adhesive system Composition Treatment Manufacturer

Optibond/Herculite XR Conditioner: phosphoric acid 38% C: 15 s, rinse, dry (wetbonding technique)

Kerr Corp, Orange, USA

Primer: ethanol, water, HEMA, GPDM(glycerophosphate dimethacrylate), MMEPor MEP (mono (2-methacryloxy) ethylphtalate. PAMM (phtalic acid amino ethylmethacrylate)

P: 30 s, dry Primer 751464 adhesive751633 composite 052892

Bonding resin (Optibond dual-cure): (Aactivator) Bis-GMA (bisphenol-glycidylmethacrylate), HEMA, GPDM, catalysts(benzoylperxide and camphorquinone) (BPaste) fumed silica, 0.6 �mbariumaluminiumborosilicate glass,Disodium hexafluorosilicate, HEMA,tertiary amine

B: apply, light light cure20 s

Permagen/Pekafill Conditioner: phoshoric acid 10% C: 15 s Permagen Ultradent ProdInc, South Jordan, Utah,USA P 0208 B 0120PekafillBayer Dental, Leverkusen,Germany 2068H

Primer: A: NTG-GMA (N-tolyglycine-glycidilmethacrylate) B: proprietary hydrophylicresin, acetone

P: 30 s, remove excess anddry 15 s

Bonding resin: 2-HEMA, Bis-GMA B: brush 20 s and air thin,light light cure 20 s

ScotchbondMulti-Purpose/Z100

Conditioner: maleic acid 10% C: 20 s, rinse, dry 3M, St Paul, Mn, USAP920327 7540

Primer: 40% HEMA, 13% polyalkenoic acidcopolymer with methacrylate groups(Vitrabond polymer), water 50 vol%; 30 s,gently air dried

P: 30 s, dry

Bonding resin: HEMA, Bis-GMA,Hexafluorphosphate, photoinitiator;applied and light cured 20 s

B: brush, air, light cure20 s

Syntac classic/Tetric Conditioner: 36% phosphoric acid C: 15 s Ivoclar/Vivadent, Schaan,Liechtenstein P 440206 A440268 H440356 T 462276

Primer: 25% triethylenglycol dimethacrylate(TEGDMA), 4% maleic acid, 41 and 30%water

P: 15 s, dry

Adhesive: 35% PEGDMA (polyethylene glycoldimethacrylate), 5% glutaraldehyde, 60%water

A: brush

Resin (Heliobond): 60% Bis-GMA, 40%TEGDMA

R: brush, light light cure15 s

PSA/Dyract Self-etching Primer: PENTA(dipentaerythrietol pentacrylatephosphonate ester), TEGDMA, elastomericurethane-modified Bis-GMA resin (R-5-62),fluoride, acetone, photoinitiator

P: 10 s, dry light cure 20 s DeTrey/Dentsply,Konstanz, Germany

Vitremer Primer: polyacrylic acid modified withgrafted pendant HEMA groups, 2-HEMA,ethanol, photocuring initiators (CQ) powder:fluoroaluminosilicate glass/70w%),potassium persulphate and ascorbic acid(patented catalyst system), benzoylperoxide liquid: a copolymer of poly (maleicacid) and HEMA = polyacrylic acid modifiedwith grafted pendant HEMA groups(MA-PAA) (15w%), 2-HEMA (5w%), water(8wt%), Camphoroquinon, photoinitiator:microencapsulated water-soluble ascorbicacid/potassium persulfate

Light cure 20 s 3M, St Paul, MN, USA

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918 d e n t a l m a t e r i a

ronment factors like moisture, physical stresses, chewinghabits, dietary components and changes in temperature andpH, acting simultaneously, may accelerate degradation of thebiomaterial–tooth interfacial bond. Several studies observedthat dentin bond strength declines over time as a result ofmechanical and hydrolytic degradation [7,12–15]. A large dropin micro-tensile strength between one-day and one-year agedspecimens have also been observed [16]. In a recent longi-tudinal follow-up study the continuous degradation of thedentin–resin bond over longer time periods expressed by theincreasing loss rates of restorations in non-carious cervicallesions was observed [8]. This was confirmed by the retentionrates observed in the present study.

Replacements of adhesive materials after only a few yearson the market by modified successors, claimed to be betterwithout clinical validation, is common practice in operativedentistry. Long-term trials have been limited in number. Peu-mans et al. observed that only 40% of Class V clinical trialswere published as peer reviewed articles [4]. Most of thesetrials were 3-year or shorter follow-ups and only a few stud-ies reported observation times up to 5 years and longer. Thepresent study is the second part of long-term evaluations ofClass V adhesive restorations placed in non-carious cervicallesions [8,9]. In the first part only one of seven investigatedadhesive systems was still marketed at the end of the 13-yearfollow-up. In the present study a higher frequency, four outof six, adhesive systems were still used. The latest guidelinesof the American Dental Association (Dental and enamel adhe-

sive materials: ADA, Council on Dental Materials, Instruments,and Equipment, 1994) for submission of dentin and enameladhesive materials require for provisional acceptance at thesix-month recall a retention rate of at least 95% of the restora-

Table 2 – Reported retention rates of restorations placed with th

Bonding Reference Years of evaluation

SBMP Van Meerbeek et al. [17] 2 yrsDuke at al. [18] 1 yr

Tyas [19] 6 mo, 12 mos, 24 mosTyas [20] 2 yrsVan Meerbeek et al. [21] 3 yrsTrevino et al. [22] 3 yrs

Platt et al. [23] 2 yrsPlatt et al. [24] 3 yrsBrowning et al. [25] 1 yrBrowning et al. [26] 2 yrsvan Dijken [27] 6 mos, 18 mos, 5 yrsOzgunltay, Onen [28] 3 yrsAw et al. [29] 1 yrAw et al. [30] 3 yrs

Syntac classic Cury et al. [31] 1 yrMazer et al. [32] 3 yrsTyas [33] 2 yrsFolwaczny et al. [34] 2 yrsvan Dijken [27] 6 mos, 18 mos, 5 yrs

Optibond Bayne et al. [35] 2 yrsBoghosian [36] 2 yrsvan Dijken [27] 6 mos, 18 mos, 5 yrs

4 ( 2 0 0 8 ) 915–922

tions placed. To obtain full acceptance, a retention of 90%after 18 months is required. No long-term retention figuresare required. Three of the adhesive systems, one three-stepetch-and-rinse, one self-etch system and the resin-modifiedglass ionomer cement fulfilled both the provisional and thefull acceptance. In vitro as well as in vivo, large variations havebeen observed for the individual adhesive systems (Table 2 )[1,12,17–68]. In vivo, the skill and experience of the operator isa source of variability in the results. In the present study allbonding systems were handled and restorations performedby the same dental team, in order to decrease the effect of theoperator factor. This allows ranking of the systems tested butdoes not give information about variations in durability of thesystems due to operator variability.

The best retention figures in the present study wereobserved for the resin-modified glass ionomer cement Vit-remer and the etch-and-rinse adhesive systems Syntac classicand Optibond. The good clinical bond of the resin-modifiedglass ionomer cement confirmed short-term results of severalother clinical investigations, despite their low bond strengthvalues reported in the laboratory [1]. Few clinical evaluationsinvestigated Optibond and Syntac classic. Three Class V abra-sion lesion studies, using bevelling and etching of the incisalenamel, reported no lost restorations after 1–2 years for Opti-bond [35–37]. One of these reported recently a 3% loss ofretention evaluating 36 of the original 80 restorations at base-line [38]. A 2.3% failure rate of only dentin-bonded restorationswas observed after 18 months [27]. The Syntac classic sys-

tem showed no lost restorations in one 1-year and one 3-yearfollow-up [31,32]. In both studies the incisal enamel was acidetched. Higher loss rates, 5 and 20% in two 2-years and a 15%in a 18-month follow-up of dentin-bonded lesions have been

e bonding systems investigated in the present study

Loss of retention Comments

4%, 2% No bevel etch + bevel0% A; bevel/no bevel maleic acid/phosphoric

acid9%, 14%, 27% A27% 10%maleic acid4%, 2% no bevel bevel11.3%, 2.2%, 0% A; bevel, rubberdam no bevel, rubberdam

bevel + no rubberdam11% A19% A7%, 3% Silux, bevel Z100, bevel11%, 14% Silux, bevel Z100, bevel phosphoric acid6%, 26%, 40% A5% A, bevel + etch2% Bevel + etch12% Bevel + etch

0% A; enamel etch0%, 45% A: maleic acid etch no etch5%20.0% A, enamel etch2.1%, 14.9%, 23.4% A

0%, 3% A; enamel etch enamel/dentin etch0% A, enamel etch0%, 2.3%, 13.8% A

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d e n t a l m a t e r i a l s 2 4 ( 2 0 0 8 ) 915–922 919

Table 2 (Continued )

Bonding Reference Years of evaluation Loss of retention Comments

Peumans et al. [37] 1 yr 0% A; bevel + etchBoghosian et al. [38] 13 yrs 3% A; bevel + etch

Permagen Dickinson et al. [39] 1 yr 1.4% Avan Dijken [27] 6 mos, 18 mos, 5 yrs 16.0%, 31.8%, 52.3% A, A

P&S Barnes et al. [40] 2 yrs 3 % AElderton et al. [41] 3 yrs 0% ALoher et al. [42] 2 yrs 6% ASchuster et al. [43] 1 yr 21%Tyas [44] 1 yr 3% AMerte et al. [45] 1 yr 4.8% AWicht et al [46] 1 yr 10.0% AAbdalla, Alhadainy [47] 2 yrs 0% Carious lesionsJedynakiewicz et al. [48] 3 yrs 2% ATyas [49] 2 yrs 3%Klimm et al. [50] 2 yrs 22% AWicht et al. [51] 1 yr 7.0% A; bevel + enamel etchGladys et al. [52] 18 mos 11%Tyas [53] 3 yrs 3%Merte et al. [54] 18 mos 9.3%Lenarda et al. [55] 4 yrs 17.2%, 10.0% etch no etch Cavities with

macro-retentionFolwaczny et al. [34,56,57] 2 yrs, 2 yrs, 5 yrs 9.0%, 8%, 18.0%Gladys et al. [58] 3 yrs 14.0% Avan Dijken [27] 6 mos, 18 mos, 5 yrs 0%, 4.0%, 16.0% AUnlu et al. [59] 4 yrs 41% ALoguercio et al. [60] 5 yrs 21.5%

Vitremer Mamenut, Tyas [61] 1 yr 0Schwartz et al. [62] 1 yr 0% ARobbins et al. [63] 2 yrs 0% AAbdalla, Alhadainy [47] 2 yrs 0% Carious lesionsDuke et al. [64] 3 yrs 0% AGladys et al. [52] 18 mos 0%Gladys et al. [65] 3 yrs 0%van Dijken [27] 6 mos, 18 mos, 5 yrs 0%, 4.1%, 16.3% AErmis [66] 2 yrs 5%Ozgunltay, Onen [28] 3 yrs 2%Loguercio et al. [60] 5 yrs 7%Chinelatti et al. [67] 1 yr 0%Franco et al. [68] 5 yrs 4%

tions

rp

Ssuw4[mtSntbml

A, reported as Abstracts only; yr, year(s); mo, month(s). Bevel: restoraetched with phosphoric acid.

eported compared with the annual failure rate of 2.8% in theresent study [27,33,34].

Large variations in retention have also been observed forcotchbond Multi-Purpose. Short time, 1–3-year follow-upshowed loss rates between 0 and 27% [17–30]. Annual fail-re rates in 12 studies (Table 2) varied between 0 and 13.5%,ith a medium value of 4.6%, which can be compared with the

.8% annual loss rate in the present follow-up. Brackett et al.69]observed recently a 50% marginal leakage along gingival

argins in Class V restorations. Perdigao et al. [70] reportedhat resin penetration and hybrid layer formation with thecothbond Multi-Purpose system in mineralized dentin wasot consistent. High shear bond strength values and penetra-

ion of the primer into demineralized dentin were reportedy others [71–73]. The large variations in the different studiesay be due to differences in research design such as different

esion conditioning and/or preparation methods, and different

are placed in lesions where the incisal enamel was beveled and/or

resin composites used. The system was introduced with anaqueous solution of 10% maleic acid with a polyvinyl alcoholthickener (pH 1.2) later replaced by phosphoric acid condition-ing. The primer is an aqueous solution of HEMA and a modifiedpolyacrylic acid with polymerizable methacrylate groups.Conflicting laboratory data concerning the replacement ofmaleic acid with phosphoric acid have been reported [74]. Alaboratory study has shown similar dentin bond strength val-ues for maleic and phosphoric acid [75]. Re et al. [76] reporteda technique sensitivity of the system.

In the evaluations of Scotchbond Multi-Purpose, the bond-ing system was combined with a microfilled or a hybridresin composite of the same manufacturer, Silux and Z100,

respectively. It has been suggested that the clinical reten-tion of an adhesive restoration depends, not only on theretention capacity of the adhesive system used but prob-ably also on the visco-elastic properties of the restorative
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r

920 d e n t a l m a t e r i a

material used. Kemp-Scholte and Davidsson [77,78] showedthat an intermediate material with reduced elastic modu-lus may function as a stress-absorbing layer and improvemarginal sealing. If the bonding tooth surface remains intact,the flexibility of the resin composite material may play a com-pensating role in coping with remaining contraction stresses[79]. When restoratives with relatively low Youngıs mod-uli of elasticity are used, elastic deformation may partiallycompensate for forces created by compression of the restora-tion during function. Z100 is among the fastest curing resincomposites associated with a high contraction stress anda low flow factor [80]. Van Meerbeek et al. [17] showed ina clinical study of Class V restorations placed with differ-ent dentin adhesive systems that the retention rate wasimproved as the moduli of the resin composite declined. Hey-mann et al. [81] reported a higher retention loss for a highmodulus hybrid resin composite compared to a microfilled.These studies used older types of dentin bonding system.Studies using newer amphiphilic bonding systems could notshow the influence of differences in modulus on retentionrate [25,37,82,83]. However, all these evaluations were shorttime studies and did not show the influence of long-termaging. Browning et al. [26] investigated both Silux and Z100and reported 11 and 14% loss rates, respectively, after 2years.

The Permagen primers were similar to the Allbond 2primers, containing NTG-GMA and a proprietary hydrophilicresin in alcohol. Low shear bond strength have been reportedfor the system [73]. In an abstract, 1.4% failure rate after 1year was observed for the Permagen system [39]. In a recentstudy the Allbond 2 system showed a 54% loss rate after 13years compared to the 86.8% for Permagen, which showed thehighest and totally unacceptable loss rate in the present study[27]. Manufacturers have a clinical responsibility in marketingdental products. In the CE directives it is prohibited to placemedical devices on the market if there are founded reasonsto suspect that they compromise the safety and health of thepatient when properly applied. Failure of dental restorativeswill probably not influence general health, but degenerationand material and/or tooth fracture will certainly compromisedental health, which is unfortunately not included in thedirective requirements. The results of the present and theabove mentioned recently published follow-up studies indi-cate clearly the necessity to include clinical evaluation of newrestoratives before marketing if medical devices should pro-vide dental patients with a high level of protection.

PSA was one of the first commercial self-etching agents,which was applied to unetched dentin and enamel in combi-nation with a polyacid-modified resin composite restorative.The adhesive component PENTA, a phosphoric acid monomerwas claimed to bond ionically to the hard calcium tissues andhas been used in several successor bonding systems of thesame manufacturer [84]. The primer combines demineraliza-tion and priming in one step. It does not remove the smearlayer but creates a resin reinfiltrated smear layer. Fritz et al.[85] showed that the PSA primer, used as pretreatment of a

compomer, does not produce any visible etching pattern onenamel. Bond strength to dentin reported varied between 8and 21 MPa [53]. High variations in loss rates in Class V non-carious cervical lesions have been reported for the self-etching

4 ( 2 0 0 8 ) 915–922

primer, varying between 0 and 21% after 1–2 years [40–56].After calculating the annual failure rates of all published stud-ies, a medium annual failure rate of 5.3% per year was obtainedfor the self-etching primer (Table 2).

In some studies the incisal or occlusal margin of enamelwas beveled. The purpose of the bevel was to increase theenamel surface for adhesion and to improve the esthetic out-come. The presence of a bevel will improve retention andreduce microleakage [86–88]. Van Meerbeek et al. [17] showedthat when enamel was etched with phosphoric acid a reli-able retention of restorations was obtained also with bondingsystems which showed inferior clinical dentin retention. How-ever, several short-term follow-ups failed to show differencesin retention loss between beveled and non-beveled cavities[21,22].

It can be concluded that all systems showed a continu-ous degradation of the bond with a wide variation, which wasindependent of the adhesion strategy. The three best bond-ing systems, including a resin-modified glass ionomer cement,showed a cumulative failure rate after 13 years between 36 and41%.

Acknowledgments

This study was supported in part by the County Council ofVasterbotten and Insamlingsstiftelsen Umea University.

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