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J Am Dent Assoc, Vol 139, No 1, 53-61.
© 2008 American Dental Association
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RESEARCH

JADA Continuing Education

Application of a Dental Adhesive Using the Self-Etch and Etch-and-Rinse Approaches

An 18-Month Clinical Evaluation



Alessandro D. Loguercio, DDS, MS, PhD and Alessandra Reis, DDS, MS, PhD


   ABSTRACT
TOP
 ABSTRACT
SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Background. Laboratory investigations have demonstrated that the application of multiple adhesive coats can increase adhesive infiltration, thereby increasing bond strength values. The authors conducted an 18-month, randomized, controlled prospective study to evaluate the clinical performance of a self-etch and an etch-and-rinse adhesive in noncarious cervical lesions.

Methods. Twenty-nine patients with at least two pairs of similarly sized lesions participated in this study. The authors placed 116 restorations in one of four groups: OS2 (phosphoric acid and dental adhesive [One-Step Plus, Bisco, Schaumburg, Ill.], following the manufacturer’s recommendation [two coats]); OS4 (phosphoric acid and One-Step Plus, with four coats); TY2 (Tyrian SPE [Bisco] and One-Step Plus, following the manufacturer’s recommendation [two coats]); and TY4 (Tyrian SPE and One-Step Plus, with four coats). The authors evaluated the restorations at baseline and at six, 12 and 18 months, according to modified U.S. Public Health Service criteria. (Eight of the 116 restorations were unavailable for follow-up.)

Results. The retention rate for the TY2 group (55.5 percent) was statistically lower than that for the TY4 (77.8 percent) and OS4 (88.9 percent) groups. Only teeth in OS4 exhibited a retention rate at 18 months that was similar to that observed at baseline. Marginal discoloration occurred in all groups, and it was statistically significantly worse in TY2.

Conclusions. Multiple adhesive coats significantly improved retention rates.

Clinical Implications. Applying multiple coats of adhesive with the etch-and-rinse or self-etch approach can improve retention rates of Class V resin-based composite restorations, although not to the level of the American Dental Association’s guidelines for dentin and adhesive materials.

Key Words: Clinical evaluation; multiple adhesive coats; self-etch; etch-and-rinse; noncarious cervical lesions

Successful adhesion to hard tissues is a fundamental requirement before placement of resin-based composites. Contemporary resin-based adhesive systems are available as three-step, two-step and single-step systems, depending on how the three cardinal steps of etching, priming and bonding to tooth substrates are accomplished or simplified. The most widely used systems are the two-step etch-and-rinse and two-step self-etch adhesives. In the two-step self-etch approach, etching and priming are combined, while in the two-step etch-and-rinse approach, the priming and bonding steps are combined.1

Although several laboratory studies have been conducted to compare these two bonding approaches, the ultimate test of dental adhesives is not their performance in the laboratory but their performance in the clinical environment.2 Because of the difficulties in conducting a clinical trial, few clinical studies have compared these current bonding strategies with newer-generation adhesive systems.3–7

With regard to the self-etch approach, several studies have evaluated clinically the mild, two-step self-etch adhesive (Clearfil SE Bond, Kuraray, New York City) and found that it achieved high bond strength values to dentin, which resulted in high retention rates.8–11 On the other hand, limited information is available about the clinical performance of acidic self-etch systems, such as Tyrian SPE (Bisco, Schaumburg, Ill.) used with One-Step Plus (Bisco); further investigation is needed.7,12

Although investigators have reported good clinical performance for two-step etch-and-rinse adhesives, the simplified acetone-based One-Step Plus adhesive did not meet the American Dental Association’s (ADA) guidelines for dentin and enamel adhesive materials13 or performed rather inconsistently in different clinical trials.4,14,15 Van Dijken4 reported a retention rate of only 50 percent after three years of clinical service for teeth with noncarious cervical lesions restored with One-Step.

The simplified acetone-based dental adhesive did not meet the American Dental Association’s guidelines for dentin and enamel adhesive materials.

Some authors have suggested that imperfect hybridization or polymerization of the resin adhesive creates voids in the hybrid layer that permit nanoleakage or debonding.16,17 The thin adhesive layer over the dentin surface, however, may not be thick enough to prevent the polymerization inhibition by oxygen to which polymeric materials18 are prone, mainly when acetone-based adhesive is applied in one coat.12,17,19,20 Hashimoto and colleagues16,17 reported that they observed a poorer bond strength and higher nanoleakage within an adhesive interface when a single coat rather than multiple coats was used.

A recent short-term clinical trial has shown that the use of multiple coats of an acetone-based adhesive with either the etch-and-rinse (after phosphoric acid-etching) or self-etch (after application of an acidic primer) approach improved the retention rates of restorations in teeth with noncarious cervical lesions.12 However, six months is a rather short period to allow researchers to make definitive statements about the efficacy of multiple adhesive coats.

We conducted this study as an 18-month follow-up to a previously reported study.12 The purpose of this study was to evaluate, after 18 months of clinical service, the retention rates of an acetone-based adhesive applied using the self-etch and etch-and-rinse approaches, and to evaluate the retention rate of the acetone-based adhesive applied according to the manufacturer’s directions or after increasing the number of adhesive coats. The null hypothesis was that the two bonding strategies associated with an acetone-based adhesive would yield similar retention rates, and no significant difference would be observed, after 18 months of clinical service, when an acetone-based adhesive was applied according to the manufacturer’s directions or after increasing the number of coats.


   SUBJECTS, MATERIALS AND METHODS
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Patient selection. The University of Oeste of Santa Catarina Committee on Investigations Involving Human Subjects, Brazil, reviewed and approved the protocol and consent form for this study. Two calibrated dental students screened patients and performed pretreatment selection of teeth with cervical lesions that were identified visually or tactilely. The investigators screened patients initially to determine if they met the study entry criteria (described below). They enrolled qualified patients for the evaluation visit. They recruited qualified patients in the order in which they reported for the screening session, thus forming a convenience sample. The dental students performed the evaluations using a mouth mirror, an explorer and a periodontal probe. They used air from the air-water syringe to administer the thermal sensitivity test.

All 29 participants were healthy and had at least 20 teeth. All patients were given oral hygiene instructions before operative treatment was performed. We excluded from the study patients with extremely poor oral hygiene, severe or chronic periodontitis or heavy bruxism habits. We asked patients if they experienced spontaneous sensitivity in the cervical lesion to be treated. We excluded lesions with hypersensitivity.21

Each participant had at least two pairs of similarly sized noncarious cervical lesions without undercuts, thus fulfilling the criteria for categories 2 and 3 on the dentin sclerosis scale (Table 1Go).22 All teeth had occlusal contact and no more than 50 percent of the cavosurface margin involved enamel.23 We informed all participants of the nature and objectives of the study; however, they did not know which lesion received which treatment. We obtained written informed consent from all participants before starting treatment.


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  		TABLE 1 Dentin sclerosis scale.*

 
On the basis of an expected retention rate of 90 percent for One-Step Plus at 18 months and with an {alpha} of .05, a power of 80 percent and a one-sided test, the minimal sample size should be 29 restorations in each group to detect a difference of 30 percent between groups.24 We placed 116 restorations, 29 in each of the four groups.

Operative procedure and experimental design. The same calibrated dental students who participated in the patient screening restored all teeth under the supervision of an experienced clinician (A.D.L.). For the calibration procedure step, the experienced clinician (A.D.L.) placed five restorations (10 in all) using both of the adhesives (that is, One-Step Plus and One-Step Plus with Tyrian SPE) to identify all of the restorative steps involved in the application technique. Each operator then placed four restorations for each of the four groups under the direct supervision of the experienced clinician. We then considered the operators to be capable of performing the restorative procedures. (These restorations were not included in the study.) Each patient received at least two pairs of restorations, and we assigned the adhesive technique randomly (by tossing a coin).

The operators placed a maximum of two pairs of restorations in each patient. In this way, we used all four adhesive protocols for each patient. Before placing the rubber dam, the operators anesthetized the teeth (using Citanest, Dentsply, York, Pa.) and cleaned all lesions with pumice and water. Following the ADA guidelines,13 the operators did not prepare any additional retention or bevel. We evaluated four bonding procedures in this study, as described below.

We used the One-Step Plus adhesive system after etching with 32 percent phosphoric acid (as a two-step etch-and-rinse system) or after using the self-priming etchant Tyrian SPE (as a two-step self-etching system) (Table 2Go). We used a microfilled resin-based composite (Micronew, Bisco) with both systems. Teeth in groups 1 (OS2) and 2 (OS4) received the 32 percent phosphoric acid and One-Step Plus. In group 1, the operators applied the adhesive according to the manufacturer’s directions (that is, two coats). In group 2, they applied four coats of the adhesive. The operators restored the teeth in groups 3 (TY2) and 4 (TY4) with Tyrian SPE and One-Step Plus. In group 3, they applied the adhesive according to the manufacturer’s recommendations (that is, two coats), while in group 4, they applied four coats of adhesive (Table 2Go).


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  		TABLE 2 Composition and application of adhesive.*

 
The operators applied the resin-based composite in one to three increments and light-cured each increment for 30 seconds (VIP light-curing unit, Bisco; 600 milliwatts/square centimeter). They finished the restorations with fine-grain diamond burs and polished them with discs (Sof-Lex Pop-On discs, 3M ESPE, St. Paul, Minn.) one week after placing the restorations.

Clinical evaluation. We used slightly modified12,23 U.S. Public Health Service criteria25 to evaluate the restorations at baseline and after six, 12 and 18 months of clinical service. We evaluated the following variables: retention, marginal adaptation and marginal discoloration, postoperative sensitivity and recurrent caries. We calculated the restoration retention rates according to the ADA guidelines13:


Formula

where PF is the number of previous failures before the current recall, NF is the number of new failures during the current recall and RR is the number of currently recalled restorations.13

As experienced examiners who did not place the restorations, we performed the follow-up evaluations. For training purposes, we observed 10 photographs that were representative of each score (Alfa, Bravo, Charlie) for each criterion. Both of us then evaluated 10 to 15 teeth together (they were not included in the study sample) and on two occasions. An intraexaminer and inter-examiner agreement of at least 85 percent was necessary before we began the evaluation.25

After cleaning the teeth, we performed the evaluations using a mirror and a double probe. We, as well as the patients, did not know which adhesive material had been used in the restorations, thereby creating a double-blind study. In addition, neither we nor the subjects were aware of the experimental group to which each tooth had been assigned. Both examiners evaluated all of the restorations once and independently. When disagreement occurred during the evaluations, we had to reach a consensus.

Statistical analysis. We used descriptive statistics to describe the frequency distributions of the evaluated criteria. We conducted statistical analyses using Friedman repeated-measures analysis of variance by rank and the Wilcoxon signed rank test for significance at each pair ({alpha} = .05). In addition, we used Cohen’s {kappa} statistic to test the interexaminer agreement.


   RESULTS
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
DISCUSSION
 CONCLUSION
 REFERENCES
 
Of 50 patients, 21 were excluded from the study because they did not fulfill the inclusion criteria. Thus, we selected 29 subjects (15 men and 14 women), with a mean age of 38 years (range, 20 to 62 years; median age, 36 years). The reasons for treatment were prevention of further tooth wear and/or esthetic reasons. The operators placed 65 restorations in the maxillary arch and 51 in the mandibular arch. Approximately 65 percent of the restorations were placed in premolars and 35 percent in anterior teeth (Table 3Go). Table 4Go shows the age and sex distribution of the subjects.


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  		TABLE 3 Characteristics of noncarious cervical lesions.

 

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  		TABLE 4 Characteristics of research subjects, according to sex and age.

 
The {kappa} statistic showed excellent agreement between the examiners (0.82). Two patients with eight lesions could not be evaluated at the 18-month recall appointment because of nonattendance. Table 5Go shows the results at six, 12 and 18 months (all criteria were classified as Alfa at baseline). Figures 1Go and 2Go (page 59) show the retention rate and marginal discoloration, respectively, at all evaluation periods.


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  		TABLE 5 Evaluated restorations according to modified* U.S. Public Health Service{dagger} criteria in each experimental condition.{ddagger}§

 

Figure 1
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  		Figure 1. Retention rates for restorations in the four experimental groups at baseline and at the six-, 12- and 18-month recall visits. TY2: Tyrian SPE self-priming etchant (Bisco, Schaumburg, Ill.) and One-Step Plus dental adhesive (Bisco), with two coats of adhesive. TY4: Tyrian SPE and One-Step Plus, with four coats of adhesive. OS2: phosphoric acid and One-Step Plus, with two coats of adhesive. OS4: phosphoric acid and One-Step Plus, with four coats of adhesive.

 

Figure 2
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  		Figure 2. Percentage of restorations classified as Alfa for marginal discoloration at baseline and at the six-, 12- and 18-month recall visits. TY2: Tyrian SPE self-priming etchant (Bisco, Schaumburg, Ill.) and One-Step Plus dental adhesive (Bisco), with two coats of adhesive. TY4: Tyrian SPE and One-Step Plus, with four coats of adhesive. OS2: phosphoric acid and One-Step Plus, with two coats of adhesive. OS4: phosphoric acid and One-Step Plus, with four coats of adhesive.

 
Retention rates. Six restorations from the TY2 group were lost after six months, and another six were lost after 18 months. Using the equation in the ADA guidelines,13 we calculated the 18-month retention rate to be 55.5 percent for the TY2 group. For the TY4 group, only one restoration was lost after six months, another two were lost after 12 months and three more were lost after 18 months. The retention rate for the TY4 group was 77.8 percent after 18 months. One restoration in the OS2 group was lost after six months, another two were lost after 12 months and five more restorations were lost after 18 months. The retention rate for the OS2 group was 70.4 percent after 18 months. For the OS4 group, only one restoration was lost after six months and another two restorations were lost after 18 months. The retention rate was 88.9 percent after 18 months for this group.

Etch-and-rinse vs. self-etch groups. Eleven restorations from the etch-and-rinse group (eight from OS2 and three from OS4) and 18 restorations from the self-etch group (12 from TY2 and six from TY4) were lost at 18 months, resulting in a significantly different retention rate among all four groups (P < .0001). After 18 months, the retention rate for TY2 (55.5 percent) was similar only to that for OS2 (70.4 percent), but the retention rate for TY2 was statistically lower than that for TY4 (77.8 percent) and OS4 (88.9 percent). When we compared the retention rates at 18 months with those at baseline, we observed a significant difference for all groups (P < .05), except for the OS4 group (P > .05).

Marginal discoloration. We classified 12 restorations from the self-etch groups (six from TY2 and six from TY4) and nine restorations from the etch-and-rinse groups (four from OS2 and five from OS4) as Bravo (that is, superficial staining, usually localized and removable) for marginal discoloration after six months. After 12 months, we classified 13 restorations from the self-etch groups (eight from TY2 and five from TY4) and 10 restorations from the etch-and-rinse groups (five from OS2 and five from OS4) as Bravo for marginal discoloration. At 18 months, we classified seven restorations from the etch-and-rinse groups (three from OS2 and four from OS4) and eight restorations from the self-etch groups (four from TY2 and four from TY4) as Bravo for marginal discoloration; however, these differences were not statistically significant (P > .05).

Marginal adaptation. We classified five restorations from the self-etch groups (two from TY2 and three from TY4) and two restorations from the etch-and-rinse groups (both from OS4) as Bravo (that is, detectable V-shaped defect in the restoration margin when using an explorer) for marginal adaptation after six months. After 12 months, we classified only two restorations from OS2 as Bravo for marginal adaptation. After 18 months, we classified four restorations from the self-etch groups (two from TY2 and two from TY4) and two restorations from OS4 as Bravo for marginal adaptation (P = .56).

We found no secondary caries at any evaluation period. However, we did find postoperative sensitivity in three restorations from the etch-and-rinse groups (one from OS2 and two from OS4) and in three restorations from the self-etch groups (one from TY2 and two from TY4) only after 18 months of clinical service (P = .78).


   DISCUSSION
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
CONCLUSION
 REFERENCES
 
Researchers use noncarious cervical lesions as clinical models to evaluate the efficacy of adhesive systems. According to Peumans and colleagues,10 when investigating the clinical effectiveness of adhesives, researchers and clinicians should consider only studies involving Class V adhesive restorations, because noncarious cervical lesions do not involve any macromechanical retention and require that at least 50 percent of the bonding be to dentin. Thus, if the bond fails, the restoration will debond, which is the most objective evaluation parameter of clinical studies.

ADA guidelines. According to the ADA guidelines for dentin and enamel adhesive materials,13 less than 5 percent of the restorations can be lost (that is, a rating of Charlie) and less than 5 percent of the restorations can exhibit microleakage at the six-month recall visit. At 18 months, less than 10 percent of restorations can be lost and less than 10 percent of restorations can exhibit microleakage.13

This study showed that the dental adhesive used with the self-etch or etch-and-rinse approach did not meet the ADA guidelines when used according to the manufacturer’s directions. Brackett and colleagues7 also reported this finding. This result was expected, because laboratory investigations have reported low bond strength values for acidic self-etch systems,8,11,26 such as Tyrian SPE, which we used before applying the dental adhesive.

Can Say and colleagues26 recently evaluated One-Step Plus under both bonding approaches. They reported statistically lower bond strength values when Tyrian SPE and One-Step Plus were used (22.4 megapascals) than when phosphoric acid and One-Step Plus were used (38.8 MPa). It is known that the characteristics of the adhesive resin placed over the self-priming etchant play an important role in the performance of self-etch adhesives, because the mechanical properties of the polymer formed within the hybrid layer are relevant to the integrity of the adhesive interface.27,28 The performance of these materials can be improved through the application of a solvent-free hydrophobic adhesive layer29 or via placement of consecutive coats of dental adhesive.16,17,19,20 In our study, applying multiple coats of the dental adhesive improved its clinical performance with either the etch-and-rinse or self-etch approaches.

Etch-and-rinse approach. In the etch-and-rinse approach, we can hypothesize that the first coat serves as a primer. The additional coats may remove more water from demineralized dentin, permitting increased resin concentration in the collagen fibril network, as shown by Hashimoto and colleagues16,17 and el-Din and Abd el-Mohsen.30 This longer diffusion time probably produced improved resin impregnation into the exposed collagen web, which might have been responsible for the higher retention rates of the dental adhesive in the etch-and-rinse groups. Multiple adhesive coats also allow more time for removal of water and solvents, as well as diffusion of adhesive monomers into collagen fibril spaces. Although we did not observe any significant differences between the OS2 and OS4 groups after 18 months, only the results from the latter group were statistically similar to those at baseline. This seems to indicate that the use of multiple coats could have retarded the degradation of the dentin bonds.

Self-etch approach. Investigators have reported inconsistent bonding performance for strongly acidic self-etch adhesives.8,11,26 Water is required to dissociate these weak acids into ionized forms for permeation of the underlying intact tooth substrates. It seems that the higher the acidity of the system, the higher its water content. According to Pashley and colleagues,31 mixtures that contain high concentrations of ethanol and water, such as Tyrian SPE, may impair polymerization of the monomers within the demineralized tooth substrates.19,20

The solvent-rich acidic primer used in our study (Tyrian SPE) is not covered by a solvent-free resin bonding layer. Instead, the acidic primer is covered by a solvent-rich acetone-based adhesive (One-Step Plus). While some adhesive systems use a solvent-free hydrophobic adhesive layer (for example, Clearfil SE Bond, Kuraray, and AdheSE, Ivoclar Vivadent, Amherst, N.Y.), other systems, such as the one tested in our study, recommend the use of a solvent-rich, hydrophilic adhesive coat. This hydrophilic adhesive did not prevent the formation of a permeable membrane after polymerization.32

The mechanical properties of the dental adhesive used in our study were even lower when equal amounts of the adhesive were mixed with the self-etching primer, which probably was due to an increase in the amount of solvent within the mass of the bonding resin.33–35 The higher the remaining solvent content, the lower the mechanical properties of the polymer formed.33–35 In a recent study, Reis and colleagues35 could not attain cohesive strength with the restorations placed with One-Step without increasing the air-stream period and the light-curing time. Even under improved conditions, the cohesive strength of the One-Step systems was lower than that of the other adhesives. The incomplete removal of solvents may prevent the attainment of an adequate degree of conversion, which, in turn, is responsible for the low mechanical properties of this adhesive, the low resin-dentin bond strengths11,26,35 and the low retention rates, as reported in clinical trials lasting six to 36 months.4,7,12,14,15

Multiple adhesive coats. One could attribute the better performance of the four-layer groups to the increased thickness of the adhesive layer. However, reports in the literature suggest that the quality of the adhesive layer, rather than the thickness, is responsible for the improved performance.16,17,36 When multiple coats of adhesive are used, and the solvent evaporates between each coat, the concentration of monomers should increase after each coating, thereby facilitating their infiltration with minimal increase in the thickness of the adhesive layer.36

According to Hashimoto and colleagues,17 when multiple coats are applied but not cured until all coats have been applied, the improvement in bonding performance is attributable to the improved quality of the adhesive layer, not to the increase in adhesive thickness. Only when each coat is light-cured before the next coat is applied can the thickness of the adhesive layer be increased.36

We also can assume that multiple coats can increase the rate of solvent evaporation owing to the active adhesive application and the extended period of time that the adhesive remains on the dentin surface before light-curing. Consequently, this could lead to an increase in the concentration of the monomers inside the hybrid layer after each coat is applied.19,20

Marginal discoloration also is an indirect indicator of the performance of a bonding technique. For instance, at six months, we classified 21 restorations in our study as Bravo. Of these 21 restorations, 14 had debonded at the 18-month evaluation, which suggests that marginal discoloration can occur before the debonding process. However, future studies are needed to investigate the correlation between marginal discoloration and retention rates.

Although self-etch adhesives are easy to apply and less technique-sensitive than etch-and-rinse adhesives, the former exhibit faster bonding degradation, mainly when acidic self-etch systems are used.4,5,7 Applying multiple adhesive coats can improve the clinical performance of the acetone-based adhesive (One-Step Plus). More studies with other solvent-based adhesives (primarily ethanol/water-based adhesives) are needed to confirm the reproducibility of our findings.


   CONCLUSION
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
REFERENCES
 
Although application of multiple adhesive coats significantly improved the retention rates of restorations placed with the acetone-based adhesive (One-Step Plus), none of the tested groups in our study experienced retention rates that met the ADA guidelines.13


   FOOTNOTES
 

Dr. Loguercio is an associate professor, Department of Dental Materials and Operative Dentistry, Universidade do Oeste de Santa Catarina, Campus Joaçaba, R. Getúlio Vargas, 2125-Bairro Flor da Serra, CEP 89600–000, Joaçaba, Santa Catarina, Brazil, and University Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brazil, e-mail "aloguercio{at}hotmail.com". Address reprint requests to Dr. Loguercio.


Dr. Reis is an associate professor, School of Dentistry, Department of Dental Materials and Operative Dentistry, Universidade do Oeste de Santa Catarina, Campus Joaçaba, Santa Catarina, Brazil, and University Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brazil.


DISCLOSURE: The adhesive materials used in this study were donated by Bisco, Schaumburg, Ill.


This investigation was supported in part by Universidade do Oeste de Santa Catarina, Campus Joaçaba, Santa Catarina, Brazil, and by CNPq grants 305075/2006–3 and 305870/2004–1.


   REFERENCES
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 

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