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J Am Dent Assoc, Vol 136, No 5, 656-664.
© 2005 American Dental Association
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ESTHETIC & RESTORATIVE CARE

JADA Continuing Education

The clinical performance of one- and two-step self-etching adhesive systems at one year



L. SEBNEM TÜRKÜN, D.D.S., Ph.D.


   ABSTRACT
TOP
 ABSTRACT
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
Background. The author compared the clinical performance of a two-step self-etching adhesive system and a one-step self-etching adhesive system over one year.

Methods. Thirty-five patients with noncarious cervical lesions were enrolled in the study. The author restored 163 lesions using a two-step (Clearfil Protect Bond, Kuraray, Osaka, Japan) or a one-step (Xeno III, Dentsply/DeTrey, Konstanz, Germany) self-etching adhesive system. Enamel margins were not beveled, and no mechanical retentions were placed. The author evaluted the restorations at baseline and at three, six, nine and 12 months after placement using modified Ryge criteria for color-matching ability, marginal discoloration, marginal adaptation, initial caries formation, anatomical form, postoperative sensitivity and retention loss.

Results. The author assessed the changes in the parameters using the Cochran Q test and the McNemar test at a significance level of .05. At one year, the retention rates for the restorations in the two-step group were 100 percent; they were 96 percent for the restorations in the one-step group. Of the retained 75 restorations from the one-step group, two had marginal discoloration and slight anatomical form problems. In both groups, color-matching ability and postoperative sensitivity remained excellent.

Conclusion. The performance of both self-etching adhesive systems was excellent during this one-year clinical trial. However, the two-step system exhibited slightly better retention than the one-step system.

Clinical Implications. The one- and two-step self-etching adhesive systems evaluated in this study provided excellent clinical retention in noncarious lesions without mechanical retention.

Key Words: Self-etching adhesive; non-carious cervical lesions; antibacterial adhesive system

In the last two decades, traditional mechanical methods of retaining restorative materials have been replaced, to a large extent, by tooth-conserving adhesive methods.1 The establishment of adhesion of restorative materials to dentin has helped dentistry overcome many problems caused by marginal leakage. This has contributed not only to long-term survival of restorations but also to the establishment of hermetic sealing of the dentinal surface, which is biologically important.2

The performance of both self-etching adhesives systems was excellent during this one-year clinical trial.

Dentin bonding systems are available as three-step, two-step and one-step systems, depending on how the three steps—etching, priming and bonding to tooth substrates—are accomplished or simplified.3 The total-etch systems are offered as three- or two-step systems (self-priming or one-bottle). The self-etching systems are divided into two- or one-step systems (all-in-one).4 There is a trend to move away from multicomponent bonding systems toward simplified, consolidated adhesives that are user-friendly. With the self-etch approach, there is no etching and rinsing step, which reduces not only the clinical application time but also the sensitivity of the technique and the risk of making errors during the application process.

The self-etching adhesive systems can be divided into "strong" and "mild" groups. Strong self-etching adhesive systems usually have a pH of 1 or lower. This high acidity results in rather deep demineralization effects. On enamel, the resulting acid-etch pattern resembles that of a phosphoric acid treatment after a total-etch approach.5 In the dentin, the collagen is exposed and nearly all hydroxyapatites are dissolved. Mild self-etching adhesive systems generally have a pH of approximately 2 and induce only a shallow partial demineralization no deeper than 1 micrometer in dentin. Micromechanical interlocking is obtained through hybridization of the microporous hydroxyapatite-coated collagen network. With the mild self-etching adhesive systems, the thickness of the hybrid layer is much thinner than that with the strong self-etching adhesive systems or the total-etch approach, but they have been proven to be as effective with regard to bond strength.6–8

The next generation of adhesive systems must include biofunctional or bioactive materials to provide an oral health benefit. Being antibacterial is one property proposed for such beneficial bio-materials.2 With the increase in minimal intervention dental treatments, it is possible that some bacteria are inadvertently left behind, owing to dentists’ tendency to remove less tooth structure when performing minimal restorations. Ratledge and colleagues9 reported that approximately 102 colony-forming units of bacteria were found beneath the marginal ridge after tunnel cavity preparation. They suggested that such incomplete removal of infected dentin is the cause of tunnel restorations’ failures. Antibacterial self-etching systems are considered to be beneficial for killing bacteria that reside in the cavity. Their use subsequently increases the success rate of minimally invasive treatments.10 Since 1995, Imazato and colleagues11,12 have conducted investigations on the use of the antibacterial monomer methacryloxy dodecyl pyridinium bromide (MDPB) for dentin bonding systems. In 2004, an antibacterial self-etching adhesive system containing MDPB—Clearfil Protect Bond (Kuraray, Osaka, Japan)—was introduced with the aim of showing strong bactericidal activity against residual bacteria in the cavity when applied, as well as inhibition to the bacteria that invade through microleakage after being cured by a "contact active" effect.13 The same group of investigators confirmed that MDPB-containing primer could show antibacterial effects in vivo using animal models, and the usefulness of the antibacterial dentin bonding system has been validated.14 However, no clinical investigations about their clinical performance have been undertaken yet.

Dentin bonding systems mainly have been tested clinically in noncarious cervical lesions (NCCL). Such model lesions are ideal test cavities because they are shallow, have no macromechanical undercuts and usually are found in anterior teeth or premolars with good access in patients who have better-than-average oral hygiene.1,15–22 However, clinical trials are limited in number and require several years with regular recall appointments to achieve sufficient clinical validation. Owing to the rapid evolution in adhesive technology and the high turnover of adhesive products, these materials are released on the dental market without sufficient proof of their clinical performance.1,23–26 Nevertheless, clinical trials of adhesive systems remain the ultimate proof of clinical effectiveness.

I conducted a clinical investigation to assess the one-year performance and the retention rate of a one-step self-etching adhesive system (Xeno III, Dentsply/DeTrey, Konstanz, Germany) and an antibacterial two-step self-etching adhesive system (Clearfil Protect Bond) in noncarious cervical lesions restored with the same microhybrid resin-based composite Esthet-X (Dentsply/ DeTrey).


   MATERIALS AND METHODS
TOP
 ABSTRACT
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
I enrolled 35 patients—19 women and 16 men—who had an average age of 44 years (range, 26–59 years) in the study. I obtained written consent from each patient at the start of the study, and the human ethical research committee of Ege University, Izmir, Turkey, approved the protocol. I placed 163 restorations in NCCL with no undercuts. I excluded Class V carious lesions. In general, no more than 50 percent of the cavosurface margin involved enamel, and at least 75 percent of the surface area of the restoration was in contact with dentin. All of the restored teeth made contact with the opposing teeth in normal occlusion relationships, and the study participants had normal periodontal health.

To minimize the possible effects of subject-related factors, I placed no more than three restorations per subject for each adhesive system, except in the case of one subject who received four restorations using the two-step adhesive system and three restorations using the one-step adhesive system. Otherwise, all of the subjects received an equal number of restorations using both types of adhesive systems. I checked for evidence of both occlusal stress and dentinal sclerosis. Using stone casts I obtained by taking impressions before the procedure, I measured the lesion depths with a periodontal probe. I randomized the distribution of materials and tooth location; the axial depths of the lesions were similar and varied from small (< 1 millimeter) to moderate (1–2 mm) (Table 1Go).


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  		TABLE 1 DISTRIBUTION OF THE MATERIALS AMONG MAXILLARY AND MANDIBULAR ARCHES, AXIAL DEPTH AND NUMBER WITH PREOPERATIVE SENSITIVITY.

 
I performed operative procedures without local anesthesia to control the reduction in pre-operative sensitivity. Using a vitality tester, I recorded vitality test scores before I placed any restorations. I then cleaned cavities with a flour of pumice and water in a rubber cup attached to a low-speed handpiece, rinsed them with water and dried them with oil-free air before making a shade selection. I isolated the teeth with cotton rolls and gingival retraction cord. I performed no mechanical tooth preparations or abrading of tooth surfaces and enamel bevels before I applied the adhesive systems. I prepared, restored and finished 163 cavities, following standard procedures and manufacturers’ recommendations.

The self-etching adhesive systems tested were Clearfil Protect Bond (lots 02030 and 020311) and Xeno III (lot 026001237) whose properties are presented in Table 2Go. Clearfil Protect Bond is a two-step self-etching system with an antibacterial component (MDPB), and Xeno III is a one-step self-etching system. I applied the adhesives randomly to neighboring lesions if possible or in the left and right part of the same dental arch.


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  		TABLE 2 COMPOSITION OF MATERIALS TESTED.*

 
For the one-step self-etching adhesive group, I mixed one drop of the primer and the adhesive for five seconds in a dappen dish and applied the mixture over the entire surface of the abrasion for 20 seconds. I then removed the solvent with an air syringe for five seconds and light cured the surface for 10 seconds.

I applied the two-step adhesive system’s primer amply on all surfaces of the lesions, left it undisturbed for 20 seconds and then evaporated it with an air syringe. I applied the bonding agent with a brush, spread it gently with an air syringe and light cured it for 10 seconds. I used the Degulux (Degussa, Düsseldorf, Germany) light-activating unit, which I tested before each placement to ensure an output in excess of 450 watts per square mm.

The light-curing resin-based composite I used to restore all the teeth was Esthet-X (lot 001206). Its properties are listed in Table 2Go. I built-up the restorations vertically, parallel to the long axis of the tooth using an incremental technique. I polymerized each increment for 20 seconds using the visible light-curing device. After polymerization was complete, I finished the restoration under water spray cooling with flame diamond burs to remove gross excess, followed by the Enhance (Dentsply/DeTrey) disk and the one-step microdiamond polisher PoGo (Dentsply/DeTrey, lot 020409) to obtain a smooth reflective surface.

I examined the restorations at baseline (one week postoperative) and at three, six, nine and 12 months. I evaluated all of the restorations using modified Ryge criteria,27 commonly known as U.S. Public Health Service (USPHS) criteria. Evaluation parameters included color-matching ability, marginal adaptation, loss of anatomical form, marginal discoloration, initial caries formation, postoperative sensitivity and retention rate. For each of the criteria, Alfa indicated the highest degree of clinical acceptability; Bravo and Charlie indicated progressively lessening degrees of clinical acceptability (Table 3Go).


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  		TABLE 3 MODIFIED RYGE DIRECT EVALUATION CRITERIA.*

 
Two volunteer clinicians who were trained in the technique and not involved with the treatment procedures evaluated each restoration. When disagreement between the evaluators occurred during evaluation, the final decision was made by consensus of the evaluators, who were calibrated before the study by a joint examination of 20 resin-based composite restorations each. They evaluated the subjects’ tooth sensitivity before and after the restorative procedures using a visual analog scale after a three-second air blast was directed at the restoration site from a distance of one inch. The evaluators recorded vitality tests and took color photographs at the baseline and at each recall appointment.

They calculated restoration retention rates using the following equation, in which PF equals the number of previous failures before the current recall, NF equals the number of new failures during the current recall, and RR equals the number of restorations recalled for the current recall: cumulative failure percentage = [(PF + NF)/(PF + RR)] x 100 percent. No more than three restorations with the same adhesive system were placed in one subject, except for one subject who received four restorations using the two-step system and three restorations using the one-step system. For each subject, the number of teeth restored using each adhesive system was equal, so that each restoration could be compared with its own same-subject control. I used Cochran Q test analysis to examine the changes across the five time points, for each of the criteria listed in Table 3Go. I compared the two adhesive systems in the same recall period for each of the criteria using the McNemar test. For all of the statistical analyses, {alpha} was set at .05.


   RESULTS
TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 CONCLUSIONS
 REFERENCES
 
All of the 163 restorations placed in the 35 subjects were evaluated and assigned scores at baseline and at each recall appointment during the one-year period (Table 4Go). Subjects retained all of the 85 restorations that used the antibacterial two-step adhesive system (Clearfil Protect Bond) after one year. However, a total of three one-step adhesive system (Xeno III) restorations were lost at the three-, six- and 12-month recall appointments. Of these three failed restorations, two were in the same subject’s left mandible. One failed at three months (Figure 1Go), and the other failed at six months. These restorations were not evaluated further. Using the revised ADA acceptance program guidelines for dentin and enamel adhesive materials,28 the evaluators calculated the 12-month retention rates to be 100 percent for the antibacterial two-step self-etching adhesive system group and 96 percent for the one-step self-etching adhesive system group. The Cochran Q test revealed no statistical difference among the different adhesive systems tested (P ≤.05).


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  		TABLE 4 RYGE CRITERIA OBTAINED AT EACH RECALL.*

 


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  		Figure 1. At the three-month recall appointment, a small mandibular restoration from the one-step self-etching adhesive system group was lost. The other noncarious cervical lesion restorations in premolars and molars were perfect.

 
Esthetics, gingival response, tooth vitality and postoperative sensitivity were all rated satisfactory for the two adhesive systems investigated (Figure 2Go). None of the restorations showed evidence of initial caries formation. The possible effect of clinical covariables, such as dentinal sclerosis, lesion size and shape, tooth type and location in the arch, occlusal function, and the age of the subject on the clinical effectiveness could not be demonstrated.



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  		Figure 2. Perfect restorations of noncarious cervical lesions at one year. The maxillary first incisor and both maxillary and mandibular premolars were restored using the one-step self-etching adhesive system, while the mandibular incisors were restored using the two-step self-etching adhesive system.

 
One restoration from the two-step adhesive system group exhibited marginal discoloration at one year, owing to an excess amount of the resin-based composite (Figure 3Go). In one subject, at the six-month recall, both maxillary central incisors restored using the one-step adhesive system had marginal discoloration, owing to excess use of the material. Another subject’s mandibular left second premolar restoration bonded using the one-step adhesive system had a slight marginal discoloration at one year (Figure 4Go). The maxillary left first premolar restored using the onestep adhesive system had a slight marginal adaptation problem and an anatomical form problem at the last recall appointment.



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  		Figure 3. A large restoration from the two-step self-etching adhesive system group exhibit a marginal discoloration at one year, owing to an excess of the resin-based composite. This discoloration could be removed by repolishing.

 


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  		Figure 4. Mandibular left second premolar restored using the one-step self-etching adhesive system, showing a slight marginal discoloration at one year.

 
At baseline, 139 of the 163 lesions exhibited hypersensitivity. None of the teeth that were sensitive to a blast of air preoperatively exhibited sensitivity after the placement of the restoration or during the rest of the study.


   DISCUSSION
TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
CONCLUSIONS
 REFERENCES
 
The clinical performance of adhesives has improved significantly, allowing adhesive restorations to be placed with a highly predictable level of clinical success. Most of the modern adhesive systems are superior to their predecessors, especially in terms of retention, which no longer is the main cause of premature clinical failure.1,29

To be considered clinically effective, adhesive systems should keep the restoration in place for a significant time and completely seal the restoration margins against the ingress of oral fluids and microorganisms. Incomplete marginal sealing will result in postplacement sensitivity, marginal staining and, eventually, recurrent caries, which still are the most common symptoms associated with clinical failure of adhesive restorations.30 According to the American Dental Association Acceptance program guidelines for dentin and enamel adhesive materials,28 a bonding system should have no more than 5 percent of lost restorations and no more than 5 percent of marginal discolorations at the six-month recall. To obtain full acceptance, the cumulative clinical failure must be lower than 10 percent of the lost restorations and show less than 10 percent microleakage after 18 months. Both of the self-etching adhesive systems I studied fulfilled these requirements for six months.

In the oral cavity, multiple and mutually interactive clinical variables related to the adherent and its immediate environment determine the clinical effectiveness of newly developed adhesive systems.15–17 The possible effect of dentinal sclerosis, lesion size and shape, tooth type and location in the arch, occlusal function and the age of the patient may influence the clinical effectiveness of the dentin bonding systems and the restorations.23

Although it has been reported that dentinal sclerosis caused by aging may contribute to retention failure in cervical restorations,31–33 no direct correlation has been demonstrated between retention failure and patient age.34,35 In my investigation, all of the failed restorations were in young patients. Concentration of compressive and tensile stresses at the cervical area induced by eccentric or heavy centric occlusal forces may progressively dislodge and eventually debond resin restorations. Brackett and colleagues36 reported that a minimum thickness of 1 mm is necessary for the retention of the restorations in abrasion lesions. Ziemiecki and colleagues22 and Bayne and colleagues17 demonstrated that deep wedge-shaped lesions retained adhesive restorations better than did shallow saucer-shaped lesions, which offer fewer retention sites and provide less bulk for restoration. The depth of the lesion affects the clinical performance of adhesives, but the shape of the lesion does not affect a restoration’s retention.34 In my study, the three failed restorations each had a depth of less than 1 mm.

With regard to location, researchers found that retention of cervical restorations was significantly greater in the maxillary arch than in the mandibular arch.29,34 It was not clear, however, if this difference in retention was related to greater difficulty in moisture control in the mandibular arch or to a greater tooth flexure of the mandibular teeth.31 Greater flexure stress may occur because of the lingual inclination of the clinical crowns and smaller cross-sectional dimension in the cervical area. Another hypothesis may be that mandibular teeth have dentin that is more sclerosed or have fewer opened tubules.33 In my study, all the failed restorations were located in the mandible.

Browning and colleagues35 found a surprisingly high level of resin-based composite restoration failures at 12 months in their study. Although it may not seem very long, this period is long enough to begin observing evidence of a difference between the two groups if a significant difference exists. The evaluators and I think that 12 months is a reasonable length of time in which to see some meaningful results.

One of the most important aspects of resin-based composite restorations in posterior teeth is the inadequate adaptation caused by the great dentin and enamel proportion in the cervical area and the critical difference of the thermal expansion coefficient between the tooth and the restorative material.36–38 Although the evaluators and I observed detectable restoration margins (3 percent) in the one-step adhesive system group, we did not assign them Bravo ratings for marginal adaptation. According to the USPHS criteria, the Bravo rating is given to restorations that have marginal crevices27,39 and because excess material observed at the margins could be removed by repolishing. We are thinking that detectable restoration margins (excess of material) are not clinical failures, but result from improper finishing or polishing techniques and the lack of a distinct tooth margin in abrasion lesions.36

Concerning marginal discoloration, three main causes can be taken into account: the presence of excess filling material, a deficit of filling material at the margin and the formation of gaps.40,41 The evaluators and I observed marginal discolorations in three cases, which corresponded to imperfect restoration margins’ showing a surplus of the material. Refinishing and repolishing procedures could remove all the discolorations.

All treatments eliminated preoperative sensitivity to cold and air blasts. It is believed that the exposure of dentinal tubules that occurs after loss of enamel or cementum results in the hypersensitivity reaction.42 The reduction in sensitivity after cervical restoration is believed to be a result of the ability of the adhesives to seal the dentinal tubules and reduce microleakage.31,43

Self-etching adhesive systems, especially onestep systems like Xeno III, that have a low pH often have been documented as having rather low bond strength values, especially at dentin, and a high number of pretesting failures during microtensile bond strength tests.7,8,44 Besides the high initial acidity that appears to weaken the bonding performance dramatically, another concern is the effect of the residual water that remains within the adhesive interface and cannot be removed completely.2,3 According to Tay and colleagues,44–46 the one-step self-etching adhesives are permeable membranes that permit diffusion of water even after the dentinal tubules are sealed with the adhesive. The presence of residual water within the adhesive may lead to areas of incomplete polymerization of the adhesive. Although these in vitro findings for one-step self-etching adhesive systems are disappointing, the results of my clinical study did not show any performance or retention differences between the one- and two-step self-etching adhesive systems.


   CONCLUSIONS
TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
REFERENCES
 
As both adhesive systems were new to the dental market at the time of my study, no other study has compared their clinical performance. According to the findings of my clinical study, both self-etching systems performed well after one year. The incorporation of the antibacterial monomer MDPB in Clearfil Protect Bond’s primer did not seem to influence the bonding performance of the adhesive and did not produce any side effects or postoperative sensitivity.11,47,48

Although a one-year observation time is not long, the clinical problems encountered in this study were relatively minor and perhaps reflect the increased expectations for adhesives more than anything else. However, it would be helpful to evaluate these restorations five years from baseline to determine whether the retention rates of the two- and one-step self-etching adhesives are different.


   FOOTNOTES
 

DISCLOSURE
Kuraray (Osaka, Japan) and Dentsply/DeTrey (Konstanz, Germany) provided the materials used in this study free of charge.


Dr. Türkün is an associate professor, Ege University, School of Dentistry, Department of Restorative Dentistry and Endodontics, 35100 Izmir, Turkey, e-mail "sebnemturkun{at}hotmail.com". Address reprint requests to Dr. Türkün.


   REFERENCES
TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 

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