Beruflich Dokumente
Kultur Dokumente
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A randomized controlled study evaluating the effectiveness of a two-step self-etch adhesive with and without selective phosphoric-acid etching of enamel
Bart Van Meerbeek*, Padmini Kanumilli, Jan De Munck, Kirsten Van Landuyt, Paul Lambrechts, Marleen Peumans
Leuven BIOMAT Research Cluster, Department of Conservative Dentistry, School of Dentistry, Oral Pathology and Maxillo-facial Surgery, Catholic University of Leuven, Belgium
Received 11 December 2003; received in revised form 30 April 2004; accepted 19 May 2004
KEYWORDS
Bonding; Clinical trial; Cervical lesions; Composite restoration; Self-etch adhesive
Summary Objectives: The purpose of this randomized controlled clinical trial was to test the hypothesis that a two-step self-etch approach is equally effective to restore cervical class-V lesions as a self-etch approach with beforehand selective etching of enamel using phosphoric acid. Methods: Twenty-nine patients received two or four restorations randomly following two experimental protocols (paired-tooth study design): (1) A mild selfetch adhesive (Clearl SE, Kuraray) was applied following a self-etch approach on both enamel and dentin (C-SE non-etch); (2) Similar application of Clearl SE, but including beforehand selective acid-etching of the enamel cavity margins with 40% phosphoric acid (C-SE etch). Clearl AP-X (Kuraray) was used as restorative composite for all 100 restorations. The clinical effectiveness was recorded in terms of retention, marginal integrity and clinical micro-leakage after 2 years of clinical service. Results: No restoration losses were recorded. Clinical micro-leakage was slight and only rarely observed. No signicant differences were found between both groups for the diverse parameters evaluated except for the number of small incisal marginal defects, which was signicantly higher in the C-SE non-etch group (McNemar: pZ0.0391). Signicance: The clinical effectiveness of the mild two-step self-etch adhesive Clearl SE was excellent after 2 years of clinical service. Although in general no difference in clinical performance was recorded when Clearl SE was applied following either of the experimental protocols, more marginal defects at the enamel
* Corresponding author. Address: BIOMAT-Department of Conservative Dentistry, School of Dentistry, Oral Pathology and Maxillofacial Surgery, Catholic University of Leuven, Kapucijnenvoer 7, 3000 Leuven, Belgium. Tel.: C32-16-33-75-87/24-59 (secr); fax: C32-16-33-27-52. E-mail address: bart.vanmeerbeek@med.kuleuven.ac.be (B. Van Meerbeek). 0109-5641/$ - see front matter Q 2004 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.dental.2004.05.008
376
Introduction
Todays adhesives are applied following either an etch and rinse or self-etch approach [1]. Clinical trials have documented that reliable and relatively long-lasting adhesive restorations can be achieved using etch and rinse adhesives [29]. Clinical trials investigating the effectiveness of self-etch adhesives is, however, limited [1013]. Self-etch adhesives nevertheless possess the clinical advantage that no intermediary rinse step is needed, making them more user-friendly and less technique-sensitive. Furthermore, as self-etching does not open the dentin tubules, but rather dissolves/inltrates the tubule smear plug (in contrast to an etch&rinse approach that widely opens tubules), self-etch adhesives have been reported to induce signicantly less post-operative sensitivity [11,1417]. Among current self-etch adhesives, one- and two-step adhesives exist that depending on their acidity belong either to socalled mild or strong self-etch adhesives [1]. So far, a two-step application procedure outperforms the single-step procedure, as corroborated by many laboratory studies [1,1823]. While a strong self-etch approach appears more favorable when bonding to enamel [1], a mild self-etch procedure that leaves hydroxyapatite within a submicron hybrid layer available for additional chemical interaction, warrants better bonding to dentin [1,24]. Most concern remains regarding the enamel etching-capability of the relatively high-pH mild self-etch adhesives. Often in daily clinical practice, they are applied after rst having selectively etched the enamel cavity margins with conventional 3040% phosphoric acid. Indeed, mild self-etch adhesives demineralize enamel less effectively than conventional phosphoric acid-etchants that need to be rinsed off [25]. The literature is equivocal on this issue. Some studies have reported that self-etch adhesives bond less effectively to enamel than total-etch or etch&rinse systems that use phosphoric acid [2629]. Other studies have reported that both self-etch and etch&rinse adhesives perform equally well on ground enamel [25,3034]. Though the enamel-etch pattern resulting from a mild self-etch adhesive is less dened when compared to that resulting from
phosphoric-acid etching [35], no correlation was found between enamel-etch morphology and shear bond strength to ground enamel [36]. Mild self-etch adhesives have also been reported to less effectively interact with dentin, in particular when prepared by a coarse-grit diamond that resulted in a rather compact, thick and thus relatively difcult to penetrate smear layer [3740]. In addition, with regard to bond durability, bonds produced by self-etch adhesives appear more vulnerable to degradation due to areas of increased permeability present at the hybridized adhesive dentin interface complex [41]. Water was suggested to be incompletely removed and resulted in regions of incomplete polymerization and/or hydrogel formation, making the interface permeable and thus more degradation sensitive. Though new in-vitro testing methodology tends to better predict clinical performance [1,42,43], clinical trials remain needed to ultimately evaluate the clinical efcacy of such self-etch adhesives. To date, clinical trials evaluating adhesives are, however, rather scarce, the main reason for which is that manufacturers often introduce a successor product to the market even before a trial on the precursor product has been completed. Another problem of clinical trials is the many clinical variables simultaneously involved [8,44], making clear interpretations regarding clinical effectiveness of the adhesive itself often difcult or even not justied. The objective of this article is to report the 2-year results of a randomized controlled clinical trial investigating the clinical effectiveness of a representative mild two-step self-etch adhesive following a paired-tooth study design. The actual hypothesis tested was that a two-step self-etch approach is equally effective to restore cervical class-V lesions as a self-etch approach with beforehand selective etching of enamel using phosphoric acid.
Clinical effectiveness of 2-step self-etch adhesive non-etch) and compared to the application of the same adhesive following the same application protocol, but after the enamel cavity margins were selectively acid-etched with 40% phosphoric acid (control; abbreviated as C-SE etch).
377
Restorative procedure
Operative procedures were performed by two specially instructed and experienced dentists from the university dental school. If needed to prevent patient discomfort during restorative procedures, local anesthesia was applied with 1.8 ml of 2% lidocain with 1:80,000 epinephrine (Lignospan 2%, Septodont, St-Maur, France). All restorative procedures were done under rubberdam isolation using the gingival retraction clamp Ivory212 (Columbus Dental, St Louis, MO, USA). The tooth surface was rst cleansed with a slurry of pumice and water to remove the salivary pellicle and any remaining dental plaque. The dentin walls of the lesion were supercially roughened with a coarse diamond bur to remove any supercial caries or discolored tooth tissue before the bonding procedure was initiated. Tooth preparation did include a 12 mm short enamel bevel to increase surface area for bonding and to enhance aesthetics. No lining material was applied. Lesions were restored according to the manufacturers instructions (Table 1) except for the control group, when the enamel margins were beforehand selectively etched with 40% phosphoric acid (K-etchant, Kuraray) during 15 s and subsequently thoroughly rinsed, and air-dried. The natural cervical tooth anatomy was restored with Clearl AP-X (Kuraray) in minimally two increments to reduce polymerization shrinkage effects and to achieve effective setting upon curing using an Optilux 500 light-curing unit (Demetron-Kerr) with a light output not less than 550 mW/cm2. Finishing and polishing were accomplished using pinetree-shaped contouring diamonds (Komet, Lemgo, Germany), rubber points (Eve, Ernst Vetter, Pforzhein, Germany), exible discs and nishing strips (Sof-Lex Pop-On set, 3M, St Paul, MN, USA).
Table 1 Adhesive
Adhesive composition and application procedure. Components and composition Primer: 10-MDP, HEMA, hydrophilic dimethacrylate, CQ, N,N-diethanol p-toludine, water Adhesive: 10-MDP, Bis-GMA, HEMA, hydrophilic dimethacrylate, CQ, N,N-diethanol p-toludine, silanized colloidal silica 40% phosphoric acid, thickener Application procedure Apply primer for 20; gently air-blow
K-etchant (Kuraray)
Apply etchant selectively on enamel and leave for 15 s; thoroughly rinse and gently air dry (only for C-SE etch).
Bis-GMA, bisphenol-glycidyl methacrylate; CQ, dl-camphorquinone; HEMA, hydroxyethyl methacrylate; 10-MDP, 10-methacryloyloxydecyl dihydrogen phosphate.
378
Restorations were examined at baseline, 6 months, 1 year and 2 years of clinical service for retention, marginal integrity, clinical micro-leakage, postoperative sensitivity, caries recurrence, and tooth vitality. All parameters were recorded using a modied index system introduced by Vanherle et al. [45]. Color slides were made pre-operatively, at baseline and at each recall. Two independent examiners carried out all evaluations using the predetermined set of criteria [45]. The evaluators were blinded to the adhesive technique used in any given restoration. Any discrepancy between evaluators was resolved at chair side. Clinical effectiveness was determined in terms of the abovementioned parameters, of which retention (no complete loss of restoration), marginal integrity (severe defects) and clinical micro-leakage (severe discoloration) were considered as key parameters, determining the overall parameter clinical success rate.
100
100
100
100
100
100
100
100
Severe sensitivity
100
Mild sensitivity
Absence of sensitivity
94
98
94
98
Statistical analysis
Statistical analysis compared on a pair-wise basis the ratings of retention, perfect marginal integrity and absence of clinical micro-leakage between the experimental and control group using the McNemar test at a signicance level of 5% (p!0.05).
100
100
100
96
15
13
15
22
13
The clinical data for the diverse parameters evaluated are summarized in Table 2. Major parameters such as retention rate, perfect marginal integrity, absence of clinical micro-leakage, absence of sensitivity, absence of caries recurrence, preservation of tooth vitality and the overall clinical success rate are depicted as a function of time for the experimental and control group in the Fig. 1. The recall rate was 86% or higher at the different recalls for both experimental groups. Reasons for not showing up at each recall were checked. They appeared not related to any negative appreciation of the patient for the restorative work done (nor to lost restorations), but rather because of secondary reasons such as crown restoration of teeth involved (four restorations in one patient at the 1- and 2-year recall, or 4% of the total restoration number), the patient that moved to an area away from Leuven (two restorations in one patient at the 2-year recall, or 2%), or the patient that could not be reached
13
13
72
70
Retention rate
100
100
100
100
Recall rate
96
96
100
C-SE non-etch
100
C-SE non-etch
Experimental group
C-SE etch
C-SE etch
Table 2
6 months
1 year
Recall
C-SE etch
86
100
80
88
85
12
12
Results
22
10
10
95
95
100
100
100
379 retention rate for both the experimental C-SE nonetch as the control C-SE etch group. With regard to marginal integrity, statistical analysis revealed signicant differences between the two groups only at the 2-year control (Table 3). Additional selective etching of enamel margins with phosphoric acid (C-SE etch) resulted in a signicantly higher percentage of perfect marginal integrity than when the adhesive was applied following a solely self-etch approach (C-SE non-etch). At all recalls, the C-SE non-etch group revealed more enamel margin defects than C-SE etch group, of which the difference became statistically signicant at the 2-year recall. Regarding dentin margin defects, some variation in occurrence was observed with the C-SE etch group having a higher percentage of dentin margin defects than the C-SE non-etch group at the 6-month and 1-year recall, and vice versa at the 2-year recall. None of these differences were statistically signicant. All margin defects, either recorded along the enamel or dentin margins, were recorded as small. No severe enamel or dentin margin defects were recorded for both groups up to the 2-year recall. With regard to clinical micro-leakage, only 7 and 5%, respectively, of the C-SE non-etch and C-SE etch restorations demonstrated supercial, localized margin discoloration. For both groups, no
Figure 1 Graph presenting the results of the major evaluation criteria in function of time for the experimental C-SE non-etch and the control C-SE etch group.
because of unknown reasons (eight restorations in two patients at the 2-year recall, or 8%). None of the restorations was lost during the 2-year study period resulting in a excellent 100%
Table 3 C-SE non-etch McNemar pair-wise statistical analysis. C-SE etch 6-Month recalla C-SE etch Fail Perfect marginal integrity Fail No fail Enamel margin defects Fail No fail Dentin margin defects Fail No fail
a b c
No fail
3 4 7
3 40 43
O0.9999 6 44 50
4 10 14
9 25 34
O0.9999 13 35 48
8 0 8
9 26 35
0.0039 17 26 43
0 1 1
2 47 49
O0.9999 2 48 50
0 4 4
6 38 44
0.7539 6 42 48
4 1 5
8 30 38
0.0391 12 31 43
3 3 6
1 43 44
0.625 4 46 50
3 7 10
4 34 38
0.5488 7 41 48
3 1 4
3 36 39
0.625 6 37 43
Recall rateZ100% (100 out of 100 restorations examined). Recall rateZ96% (96 out of 100 restorations examined). Recall rateZ86% (86 out of 100 restorations examined).
380 deep, generalized discoloration was detected. Tooth sensitivity was almost non-existing with only mild sensitivity (to air or tactile contact) being recorded for maximum 6% of all restorations placed. Caries recurrence was not observed in the 2-year study period. No tooth became non-vital due to the cervical restoration. The overall 2-year clinical success rate was 100% excellent for both C-SE etch and C-SE non-etch. Due to the low clinical failure rates, any inuence of lesion category on the clinical outcome could be found.
B. Van Meerbeek et al. effectiveness to dentin was found between an etch&rinse and a mild self-etch approach [1]. This randomized controlled clinical trial revealed that up to 2 years of clinical service the mild two-step self-etch adhesive Clearl SE (Kuraray) performed excellent (C-SE non-etch). With regard to the primary evaluation parameters that determine the overall clinical success rate, no signicant difference was recorded with the control group (C-SE etch). The only parameter that appeared signicantly different between both groups is the higher prevalence of small enamel margin defects recorded when Clearl SE was applied following a solely self-etch approach (Tables 2 and 3). It should, however, be emphasized that these defects are small in a sense that they can hardly be spotted by the naked eye, but can only be sensed by moving a relatively sharp probe under light pressure across the restoration-tooth margin. These defects did certainly not require any repair (nor replacement of the whole restoration), and therefore should be regarded as being of clinically negligible relevance. Clearl SE is a two-step self-etch adhesive, of which the self-etching primer contains 10-methacryloxydecyl dihydrogen phosphate (10-MDP) as functional monomer dissolved in water to result in a pH of around 2 (Table 1). Clearl SE interacts with dentin rather supercially producing a hybrid layer of about 1 mm depth at maximum. The excellent clinical effectiveness of Clearl SE recorded in this study may therefore in part result from simultaneous demineralization and inltration of dentin, having lead to a shallow, but uniform and thus stable resininltrated dentin layer [14,39]. Furthermore, within the shallow hybrid layer residual hydroxyapatite around the exposed collagen brils remains available for additional chemical interaction with the functional monomer 10-MDP [1,24,47]. Following recent research, 10-MDP has been shown to chemically interact with hydroxyapatite [24]. Among three monomers investigated (10-MDP, 4-MET or 4-methacryloxyethyl trimellitic acid, and phenyl-P or 2-methacryloxyethyl phenyl hydrogen phosphate), 10-MDP revealed not only the most intense chemical interaction with hydroxyapatite, but the resultant bond with calcium appeared also most hydrolytically stable [24]. Besides self-etching, such an additional chemical bonding efcacy of 10-MDP with tooth minerals should theoretically contribute to the actual adhesive potential to dentin, but also to enamel that consists of nearly only mineral substance, with which 10-MDP can chemically react. The resulting two-fold micromechanical and chemical bonding mechanism may
Discussion
Non-carious mixed enamel/dentin class-V lesions were selected to test the clinical effectiveness of the two-step self-etch adhesive Clearl SE in this study. Cervical lesions are regarded as the ideal cavities to test the clinical effectiveness of adhesives because (1) they present no macromechanical undercuts; (2) they require for at least 50% bonding to dentin; (3) when restored, they result in an enamel as well as dentin margin; (4) they are widely available; (5) they are usually found in anterior teeth or premolars with good access and (6) they have the worst long-term prognosis because of the high proportion of dentin margins and the high stress build-up in the cervical area [1,8,46]. This clinical trial was randomized and the examiners were blinded for the adhesive approach applied per lesion and per patient. The paired-tooth design involved the placement of two or four of the two adhesive/composite protocols per patient, and this in pairs of equal teeth (rst and second premolar at the same side, left and corresponding right incisor, canine or premolar, respectively). Consequently, clinical effectiveness was pair-wise evaluated at the patient level, comparing both adhesive protocols mutually for each pair. Clearl SE (combined with Clearl AP-X) was chosen representing so-called mild two-step self-etch adhesives because of its repeatedly proven excellent performance in independent laboratory studies [1,9,18,21,23,32,34,35]. As control, Clearl SE was applied on enamel/dentin in the same manner with the only difference that the enamel cavity margins were selectively etched using 40% phosphoric acid prior to the application of Clearl SE. The rationale behind this study design was that following laboratory ndings an etch&rinse approach (including phosphoric-acid etching) still provides the most effective bond to enamel, while not much difference in bonding
Clinical effectiveness of 2-step self-etch adhesive thus to a large extent have lead to the excellent clinical performance of Clearl SE recorded in this study. It may also explain why despite the rather mild enamel-etching effect (as compared to that resulting from phosphoric-acid etching), Clearl SE bonded fairly well to enamel (no severe margin defects). Actually, the examiners could never tell which of the two restorations (per pair) was placed following a full self-etch application protocol, or following a self-etch procedure after enamel was selectively etched with phosphoric acid. Besides preventing restoration loss, such intimate monomertooth tissue interaction may also better protect the restoration against marginal leakage over time [48,49]. This was conrmed in this study, in which hardly any marginal discoloration as clinical sign of leakage was recorded, and this irrespective of if Clearl SE was applied following the experimental or control application protocol (Table 2 and Fig. 1). The retention as well as the clinical microleakage rates of Clearl SE applied following either of the two adhesive approaches exceeded by far the ADA guidelines (less than 10% restoration loss and deep restoration staining at 18 months) to acquire full acceptance [50]. Consequently, up to 2 years of clinical service the two-step self-etch approach was equally effective to restore cervical class-V lesions as the control approach that received beforehand selective etching of enamel with phosphoric acid, by which the hypothesis advanced in this study was rejected. Another factor that may have contributed to the excellent clinical performance of Clearl SE is the particle-lled adhesive resin that has a ller content of 10 wt%. Clearl SE contains nano-ller (20 nm, according to technical information provided by Kuraray), resulting in a thicker adhesive layer and thus more exible interface that is thought to relieve interfacial tensile stress (stressabsorber) between the shrinking composite and the rigid dentin substrate [5153]. Such a exible intermediary resin may also help to counteract other stress factors (like occlusal loading) that must affect the bond longevity over time. When compared to the clinical performance of other adhesives, Clearl SE as a two-step self-etch adhesive performs up to 2 years as favorable as conventional three-step etch&rinse adhesives [1,3, 4,68]. An apparently less favorable clinical effectiveness of Clearl SE with a 2-year retention rate of 93% was reported by Tu rku n [13]. Unfortunately, the actual number of restoration losses was not mentioned in that paper, since the author clearly stated that four non-recalled patients (with one to possibly three restorations) were considered to
381 have missing restorations [13]. Consequently, the actual retention rate should have been substantially higher than the reported 93% (when the nonrecalled restorations would not have been taken in consideration). In literature, no other clinical trial was found to have tested the clinical effectiveness of Clearl SE in cervical lesions. Some clinical data are available on its predecessor Clearl Liner Bond 2 (Kuraray) that also belongs to the group of mild two-step self-etch adhesives [1]. A 91% 2-year and a 92% 3-year retention rate were reported, respectively, by van Dijken [54] and Latta et al [55]. The two-step self-etch adhesive Clearl Liner Bond 2 and its successor Clearl SE differ for the functional monomer, with phenyl-P in Clearl Liner Bond 2 being replaced by the more stable 10-MDP monomer in its successor Clearl SE. One may consequently expect that Clearl SE performs clinically better than its predecessor, as conrmed in this study with a 100% retention rate at 2 years. Much less favorable clinical effectiveness is commonly recorded for other simplied two-step etch&rinse [3,4,5660] and one-step self-etch adhesives [10,54,58,61]. Patients that received Clearl SE restorations reported hardly any post-operative sensitivity. This indicates that dentin tubules as the direct connection to the pulp must have been adequately sealed by the two-step self-etch approach, thereby conrming the claim often made that self-etch adhesives better prevent post-operative sensitivity. Remaining evaluation criteria, such as caries recurrence, aesthetics, gingival response, tooth vitality and post-operative sensitivity were all rated satisfactory. Other clinical co-variables that have been described to affect adhesion to tooth tissue include patient age, dentin sclerosis, lesion size and shape, tooth type, enamel and dentin structure, tooth location and stressful occlusion, among other [8,44]. The clinical failure rates in this study were so low that no correlation could be made with these co-variables.
Conclusion
The clinical effectiveness of the mild two-step selfetch adhesive Clearl SE was excellent after 2 years of clinical service. Although in general no difference in clinical performance was recorded when Clearl SE was applied following either the experimental or control protocol, more marginal defects at the enamel side were noticed when enamel was not beforehand etched with phosphoric acid. However, these defects were small and of clinical
382 negligible relevance. Long-term recalls are planned to nd out if difference in clinical performance between the experimental and control group will occur at later restoration ages.
[15] [16]
Acknowledgements
This study was supported in part by Kuraray, by the fund No. KAN2002 1.5.142.02 Krediet aan Navorsers of the Fund for Scientic Research of Flanders, and by the Toshio Nakao Chair with B. Van Meerbeek and P. Lambrechts awarded as chairholders.
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