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J Am Dent Assoc, Vol 138, No 4, 507-514.
© 2007 American Dental Association
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RESEARCH

JADA Continuing Education

A 36-month evaluation of self-etch and etch-and-rinse adhesives in noncarious cervical lesions

Alessandro Dourado Loguercio, DDS, MS, PhD, Dax Dalton Bittencourt, DDS, MS, Luiz Narciso Baratieri, DDS, MS, PhD and Alessandra Reis, DDS, PhD


   ABSTRACT
TOP
 ABSTRACT
SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Background. There are two bonding strategies for composite restorations: the etch-and-rinse (ER) approach and the self-etch (SE) approach. Few clinical trials have evaluated the SE approach in Class V restorations for a 36-month period. The authors conducted a study to evaluate whether the SE system can provide retention rates and marginal discoloration similar to that of the ER system.

Methods. Twenty-five patients, each having at least two pairs of equivalent noncarious cervical lesions under occlusion, were enrolled in this study. Two calibrated operators placed 78 restorations, one-half for ER and one-half for SE. Two independent examiners evaluated the restorations at baseline and after six-, 12-, 18- and 36-month periods according to the slightly modified U.S. Public Health Service criteria. Statistical analysis between materials in each period was conducted using a Fisher exact test ({alpha} = .05), and the performance of the materials at baseline in comparison with each period was evaluated by a McNemar test ({alpha} = .05).

Results. Five SE restorations and one ER restoration were lost after 36 months. After 36 months, 10 SE and five ER restorations were rated Bravo in marginal adaptation (P > .05). Fourteen SE and five ER restorations were rated Bravo in marginal discoloration (P < .05).

Conclusions. Although a significantly increased marginal discoloration was observed with SE, both adhesives showed retention rates in noncarious cervical lesions that were not statistically different after 36 months.

Clinical Implications. The ER and SE adhesive systems can be used with confidence; however, SE adhesive showed a faster and more progressive enamel marginal degradation.

Key Words: Cervical lesions; adhesives; composite restorations; dental restoration failure

Abbreviations: Bis-GMA: Bisphenol-A glycidyldimethacrylate • ER: Etch-and-rinse • HEMA: 2-hydroxyethyethyl methacrylate • SE: Self-etch • USPHS: U.S. Public Health Service

Successful adhesion of tooth-color restorative materials to hard tissues such as enamel and dentin is a fundamental requirement of restoration placement.1 Resin-based adhesive systems can be classified according to the underlying strategy in either the etch-and-rinse (ER) approach or the self-etch (SE) approach. In the ER approach, the tooth is etched with 37 percent phosphoric acid and then rinsed. This conditioning and rinsing step is followed by a priming step and the application of the adhesive resin, resulting in a conventional three-step application procedure.2

Although the three-step ER strategy has been considered the gold standard, the two-step adhesive system, which combines primer and adhesive resin in one bottle, is the most-used version of the ER technique. However, this system still requires a conditioning and rinsing step.1 Although the clinical performance of several ER adhesive systems has improved over earlier systems,1,2 there are randomized clinical trials showing varying retention rates over one to three years.3–9 The technique sensitivity of the ER systems and the likely discrepancy between the extent of demineralization and monomers infiltration10 has been blamed for the degradation of these adhesives systems when they are exposed to a water environment.11,12

Another approach for bonding to dental substrates is the SE strategy. This approach involves either a two- or a one-step application procedure. The strategies are considered user-friendly since they no longer require etching and rinsing steps, which not only lessens clinical application time but also significantly reduces technical sensitivity during application and manipulation. Another advantage of the using the SE strategy is that infiltration of resin occurs simultaneously with the SE process and, therefore, the chance of there being a discrepancy between both processes is low.1,13,14

Some clinical trials report high retention rates for the two-step SE bonding product Clearfil SE Bond (Kuraray, Osaka, Japan).9,15 Few randomized clinical trials, however, have been performed to evaluate the performance of one-step SE systems. Few short-term clinical functioning trials, with observation time varying from six months to two years, generally show retention rates ranging from 76 to 96 percent for SE systems.16–19 To date, the clinical performance of Adper Prompt L-Pop (3M ESPE, St. Paul, Minn.), an acidic one-step SE, after 36 months has not been reported in the literature.

We conducted a paired-tooth, randomized, controlled prospective study to evaluate the performance after 36 months of a one-step SE system and a two-step ER system used to restore noncarious cervical lesions. We hypothesized that the onestep SE system could provide retention rates and marginal discoloration similar to those of the two-step ER system.


   SUBJECTS, MATERIALS AND METHODS
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
The materials we used in this study were Filtek A110 (3M ESPE), a microfilled resin-based composite; Adper Single Bond adhesive (3M ESPE), a two-step ER adhesive system; and the experimental EXM-618 (3M ESPE), a one-step SE adhesive system (now available as Adper Prompt L-Pop). We describe the materials in detail in Table 1Go.


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  		TABLE 1 Study materials.

 
The University of Oeste de Santa Catarina Committee on Investigations Involving Human Subjects reviewed and approved the protocol and consent form we used for this study. Two clinical investigators screened the patients and identified teeth with cervical lesions by visual or tactile means. They screened the patients to determine if they met the study inclusion criteria described below. They enrolled the qualified subjects in the study for the evaluation visit. Qualified subjects were recruited in the order in which they reported for the screening session, thus forming a convenience sample. The investigators carried out the evaluations using a mouth mirror, an explorer and a periodontal probe. They used air from the air-water syringe to administer a thermal sensitivity test.

Inclusion criteria were that all subjects be healthy and have at least 20 teeth. According to the treatment rules from the School of Dentistry, University of Oeste de Santa Catarina, Campus Joaçaba-Santa Catarina, Santa Catarina, Brazil, we gave all subjects oral hygiene instructions before we treated them. We did not include patients with poor hygiene, severe or chronic periodontitis or heavy bruxism in the study group. Each subject had to have at least two pairs of similarly sized cervical lesions (erosion, attrition or abfraction) that came into contact. The lesions had to be nonretentive and have no undercuts, and no more than 50 percent of the cavosurface margin could involve enamel.20 The cervical wall had to be located in cementum. We excluded patients with lesions with sclerotic dentin degrees of 1 or 4 and that exhibited hypersensitivity from the study.4 Additional details about the lesions in the study are provided in Table 2Go.3,21


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  		TABLE 2 Distribution of noncarious cervical lesions.

 
We informed all of the subjects about the nature and objectives of the study; however, they were unaware about where each material was placed. We obtained written informed consent from each subject before beginning treatment.

We calculated the minimal sample size on the basis of the retention rate of the ER system at 36 months being 94 percent. Using an {alpha} of .05, a power of 80 percent, a one-sided test, we determined that the minimal sample size should be 37 restorations in each group to detect a difference of 24 percent between groups.

Restoration procedures. The two investigators who participated in the patient screening restored all of the lesions. For the calibration procedure step, an experienced clinician placed four restorations of each adhesive to identify all the restorative steps involved in the application technique. Then, each investigator placed four restorations for each material under direct supervision of the experienced clinician. Only then were the investigators considered capable of initiating the restorative procedures. These restorations were not included in the study.

Each subject received at least two pairs of restorations, in which the materials were allocated randomly using a coin toss.

The subjects and lesions were prepared as follows:

– the subject received anesthetic (Citanest, Dentsply, Petrópolis, RJ, Brazil);
– the lesions were cleaned with pumice and water in a rubber cup (8040RA and 8045RA, KG Sorensen, Barueri, SP, Brazil) and then they were rinsed and dried;
– the shade was selected using Filtek A-110 shade guide (3M ESPE);
– a rubber dam (SS White, Petrópolis, RJ, Brazil) was placed for isolation;
– prophylaxis was performed;
– no additional retention or bevel was performed.

Then we applied the adhesives according to the description in Table 1Go. We filled the lesions incrementally with Filtek A110 (± three increments). Each increment was light cured for 30 seconds using a VIP light unit (Bisco, Schaumburg, Ill.) set at 600 milliwatts per square centimeter.

We finished all of the restorations with fine-grained diamond burs (1190F and 2135F, KG Sorensen). After one week, we gave the restorations a final polishing, using Sof-Lex Pop-On (3M ESPE).

Clinical evaluation. The clinical categories we evaluated were retention, color match, anatomical form, marginal adaptation, marginal discoloration, postoperative sensitivity and recurrent caries—according to the U.S. Public Health Service22 (USPHS) criteria adapted by Barnes and colleagues23 and Loguercio and colleagues20—at baseline and after six, 12, 18 and 36 months.

We calculated restoration retention rates using the following equation (given in the American Dental Association Acceptance Program Guidelines)24: cumulative failure % = ([PF + NF]/[PF + RR]) x 100%, where PF is the number of previous failures before the current recall; NF, the number of new failures during the current recall; and RR, the number of restorations recalled for the current recall. We took color slides preoperatively, at baseline and at each recall.

Two other experienced examiners (A.D.L. and A.R.) performed the evaluation. For training, they viewed five photographs representing each score in each USPHS criterion. They then examined approximately 10 to 15 teeth together twice at two different times (we did not include these examinations in the study sample). An initial intraexaminer and an interexaminer agreement of at least 85 percent were necessary before beginning the evaluation.22

The examiners performed the evaluation using a mirror and a double probe after prophylaxis. Each examiner evaluated the restoration once and independently. They were unaware of which material had been used, thus creating a double-blind study. An initial interexaminer agreement of at least 85 percent was necessary.25 When disagreement occurred during evaluation, the examiners had to reach a consensus before the subject was dismissed.

Statistical analysis. We used descriptive statistics to describe the frequency distributions of the evaluated USPHS criteria. We tested the differences in the ratings of the two materials after six, 12, 18 and 36 months using a Fisher exact test ({alpha} = 0.05). We evaluated the performance of the materials at baseline and after six, 12, 18 and 36 months using a McNemar test ({alpha} = 0.05). To measure agreement between the examiners, we used Cohen’s {kappa} statistic.


   RESULTS
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
DISCUSSION
 CONCLUSION
 REFERENCES
 
Of the 50 subjects we evaluated, only 25 were in our final selection. We placed 78 restorations, 39 with the SE material and 39 with the ER material. The subjects’ reasons for receiving treatment were prevention of further tooth wear, esthetics or both. We placed 41 restorations in the maxillary arch and 37 in the mandibular arch. We placed approximately 75 percent of the restorations in premolars and 25 percent in anterior teeth. The age and sex distribution of the subjects are presented in Table 3Go.21


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  		TABLE 3 Distribution of treated subjects and noncarious cervical lesions.

 
The Cohen’s {kappa} statistic (0.88) showed excellent agreement between the examiners. After six months, 60 restorations (30 placed with each material) in 20 subjects were available for evaluation. One reason for restored teeth’s not being available for evaluation was that the subjects did not attend the six-month recall appointment. All of the subjects who were evaluated at the six-month recall appointment were evaluated at the 12-, 18- and 36-month recall appointments.

None of the restorations had secondary caries, loss of anatomical form or postoperative sensitivity throughout the evaluation period. Regarding color match, five restorations were classified as having USPHS score of Bravo at the 36-month recall appointment. Two restorations from the SE group were lost to follow-up after 18 months and another three restorations were lost after 36 months.

Using the ADA Acceptance Program equation, we calculated the 18- and 36-month retention rates to be 93.0 percent and 83.3 percent, respectively, for the SE material.24 For the ER material, the retention rate was 96.7 percent (only one restoration was lost after 36 months) (Figure 1Go). The difference was not statistically significant between the two adhesive materials for retention rate (P > .05).


Figure 1
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  		Figure 1. Retention rates from the two adhesive systems over the evaluation period. Adper Single Bond is manufactured by 3M ESPE, St. Paul, Minn. Adper Prompt L-Pop is manufactured by 3M ESPE.

 
The restorations had preserved marginal adaptation and no interfacial staining at the six-month recall appointment. We observed marginal integrity and discoloration at the 12-, 18- and 36-month recall appointments. After 36 months, 24 SE restorations (66.7 percent) and 33 ER restorations (83.4 percent) were received a USPHS score of Alfa in the marginal adaptation (Figure 2Go). This difference was not statistically different between materials (P > .05), but it was statistically different between evaluation periods for each adhesive (baseline and 36 months, P < .05). This lack of adaptation occurred mostly at the enamel margin.


Figure 2
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  		Figure 2. Percentage of restorations receiving an Alfa score for marginal adaptation for the two adhesive systems over the evaluation period. Adper Single Bond is manufactured by 3M ESPE, St. Paul, Minn. Adper Prompt L-Pop is manufactured by 3M ESPE.

 
After 36 months, 20 SE restorations (53.4 percent) and 33 ER restorations (83.4 percent) received a USPHS score of Alfa in terms of their marginal discoloration (Figure 3Go). We detected a significant difference between these materials and between the baseline and 36-month recall periods (P < .05). This discoloration occurred at the enamel margin in the majority of the restorations.


Figure 3
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  		Figure 3. Percentage of restorations receiving an Alfa score for marginal discoloration for the two adhesive systems over the evaluation period. Adper Single Bond is manufactured by 3M ESPE, St. Paul, Minn. Adper Prompt L-Pop is manufactured by 3M ESPE.

 

   DISCUSSION
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
CONCLUSION
 REFERENCES
 
Noncarious loss of dental hard tissue at the cervical region is used as a clinical model to evaluate the efficacy of dentin bonding agents in nonretentive tooth restorations, as recommended by the ADA.24 This is due to the cervical lesions’ having no macromechanical undercuts and because they are available widely in subjects with better-than-average oral hygiene.1 These lesions require at least 50 percent bonding to dentin, and they usually are found in anterior teeth and in premolars with good clinical access. Ineffective bonding usually results in restoration loss, which is the most objective evaluation parameter of clinical studies.21

This explains why noncarious cervical lesions are used as clinical models to evaluate the efficacy of dentin bonding agents in nonretentive tooth restorations, as recommended by the ADA’s guidelines.24 To obtain provisional acceptance, dentin and enamel adhesive materials need to demonstrate that no more than 5 percent of the restorations are lost and that no more than 5 percent of the restorations show microleakage at the six-month recall. To obtain full acceptance, dentin and enamel adhesive materials need to demonstrate that the cumulative incidence of clinical failures after 18 months is less than 10 percent for lost restorations and 10 percent for microleakage.

Laboratory investigations have reported low resin-dentin bond and resin-enamel bond strength values for SE systems (Adper Prompt L-Pop and its predecessor Prompt L-Pop) compared with a two-step ER system (Adper Single Bond).26–28 The worst performance of Prompt L-Pop in in vitro studies can be attributed to several factors. According to Peumans and colleagues,21 these two SE adhesives are strong systems, capable of forming thick true hybrid layers. The thin adhesive layer over the dentin surface, however, may not be enough to prevent the inhibition by oxygen to which polymeric materials are prone,29 mainly when this material is applied in one coat.30–32

After careful application and reduction of the adhesive layer through air drying, Prompt L-Pop adhesive leaves the tooth surface with dull areas that often are apparent on the surface, representing dry spots where the material probably is too thin to be light cured successfully.30

A 2001 in vitro study demonstrated that the bond strength value of a one-step SE system after application of a second adhesive layer was as much as two times greater than that after just one adhesive layer was applied.31 Another study also demonstrated improved resin-dentin bond strengths when Prompt L-Pop was applied in multiple coats.30 We did not overlook these laboratory findings. We applied the one-step SE in two layers and took care in removing the solvent before curing the adhesive. 3M ESPE has recommended applying two coats of the SE.

It is well-documented that one-step SE systems behave as permeable membranes after polymerization.33,34 The lack of an additional coat of hydrophobic bonding resin and the presence of highly hydrophilic monomers in the SE material both cause water to be drawn from the underlying hydrated dentin35 and from the oral environment36 after polymerization. The water’s movement from the underlying dentin through the adhesive leads to the entrapment of water droplets known as "water blisters."

In our study, the clinical precautions taken during the SE application seem to be the most important reason for the high retention rate of the SE when compared with that found in other randomized clinical trials. Additional studies should be conducted to test this hypothesis, since the evaluation of the application technique was not the aim of our investigation.

Clinical evaluations of Prompt-L Pop in non-carious cervical lesions have reported retention rates of 76 to 96 percent.16–19 Brackett and colleagues18 placed 60 Class V restorations in caries-free cervical lesions using Prompt L-Pop and reported a retention rate of 76 percent after six months. Boghosian16 placed 47 Class V restorations in abfraction and attrition lesions using Prompt L-Pop and Adper Single Bond and reported retention rates of 96 and 91 percent, respectively, after one year. Friedl and colleagues17 compared Prompt L-Pop with a three-step adhesive system and reported retention rates of 84 percent and 92 percent, respectively, after two years. van Dijken19 reported retention rates of 96.1 percent, 86.5 percent, 84.6 percent and 78.8 percent for restorations placed using Prompt L-Pop applied in one-layer after six, 12, 18 and 24 months, respectively.

Many factors can be responsible for the different findings among studies—for example, inclusion and exclusion criteria, technical procedures and operators’ experience. Unfortunately, a couple of the aforementioned studies were published as abstracts and, therefore, their results should be interpreted carefully since their methodology and results cannot be investigated directly.17,18

The acidic monomers in Prompt L-Pop were methacrylated phosphoric acid esters, which are also the main components of the SE adhesive we used our study. The SE adhesive also includes polyalkenoic acid copolymer, which was added to improve its bonding efficacy and also is found in the resin-modified glass ionomer cements Vitre-bond (3M ESPE) and Vitremer (3M ESPE), as well as the ER adhesive we tested. The polyalkenoic acid copolymer can form Ca-polyalkenoate complexes at the superficial region of the hybrid layer and within the superficial 3 micrometers of dentinal tubules,37 which might stabilize the bonded interface by providing water stability and a stress-relaxing effect.38 The presence of polyalkenoic acid in both adhesive systems can explain the excellent and similar performance of the two-step ER and one-step SE adhesives we investigated.

Our findings regarding the ER’s performance are in agreement with those of other studies performed using Adper Single Bond in anterior and posterior teeth.9,16,39 In two other clinical trials, however, Adper Single Bond did not meet the ADA’s requirements for full acceptance.8,40 Brackett and colleagues’40 study showed retention rates of 84 percent and 81 percent after one and two years, respectively. Aw and colleagues’8 study showed retention rates of 81 percent after three years. In these studies, each layer of Adper Single Bond was only slightly air-dried. This may have resulted in poor solvent evaporation and a thin adhesive layer, which turned this layer into a semipermeable membrane, as with one-step SE.33,35 This may have been responsible for the high debonding observed in the aforementioned studies.

In our study, 10 SE (33.3 percent) and five ER (16.6 percent) restorations were rated Bravo for marginal adaptation at 36 months. This difference was not statistically different (P > .05). Usually, the slight lack of marginal adaptation in enamel margins does not require further treatment and, therefore, is considered to be clinically negligible. One must keep in mind, however, that the increase of these enamel defects over time may be indicative of the less stable bond of adhesive to enamel. We found a significant difference between materials for marginal discoloration. We gave Bravo ratings to 46.6 percent and 16.6 percent of the SE and ER, respectively, for marginal discoloration at 36 months. This discoloration occurred at the enamel margin for the majority of the restorations, which seems to be a common finding in clinical studies in which Prompt L-Pop was used.16–18,41,42

The higher marginal discoloration we found with the one-step SE system at enamel margins may have been due to the inferior etching pattern of these systems. Some studies have demonstrated that the resin-enamel bond strength of one-step SE systems can be improved by first conditioning the enamel with 35 percent phosphoric acid.43–45 A clinical trial that attempted to etch the dental substrates with phosphoric acid before application of a mild two-step SE adhesive found a lower percentage of marginal discoloration.15

Another way to improve the performance of SE systems in enamel is to apply the SE primer for twice the time recommended by the manufacturer. Although this clinical approach has been shown to reduce enamel microleakage46 and improve resin-enamel bond strengths47 for some SE adhesives, no improvement was reported for Adper Prompt L-Pop.47

SE adhesives are easy to apply and less technique-sensitive than ER adhesives. Clinicians should, however, consider the trade-offs of SE adhesives before using them in a routine practice. If they are used, more than one layer should be applied and extra time should be designated for the removal of solvents. Although we detected a significant difference between adhesives only for marginal discoloration, the two-step ER systems showed a trend toward having superior performance for marginal adaptation and retention. For practicing dentists, ER adhesives should be considered the first option when compared with SE. Peumans and colleagues21 also came to this conclusion in a recent systematic review of clinical trials for contemporary adhesives. They concluded that the clinical effectiveness of two-step ER adhesives was greater than that of one-step SE adhesives.


   CONCLUSION
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
REFERENCES
 
Although we observed significantly increased marginal discoloration with the SE adhesive, both ER and SE adhesives showed retention rates in noncarious cervical lesions that were not statistically different after 36 months.


   FOOTNOTES
 

DISCLOSURE: 3M ESPE, Campinas, Brazil, donated the materials used in this study.


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


Dr. Dalton Bittencourt is a professor, School of Dentistry, Department of Dental Materials and Operative Dentistry, University of Oeste de Santa Catarina, Campus Joaçaba, Santa Catarina, Brazil.


Dr. Narcisco Baratieri is a professor, Department of Operative Dentistry, Universidade Federal de Santa Catarina, Florianópolis, Brazil.


Dr. Reis is a professor, Universidade of Oeste de Santa Catarina, Campus Joaçaba-Santa Catarina, Brazil.


The University of Oeste de Santa Catarina, Campus Joaçaba-Santa Caterina, Santa Catarina, Brazil, supported this investigation, in part. The authors also thank Janice Mengarda and Iara Giovana Ezecelevski for their collaboration at the beginning of the study.


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

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