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J Am Dent Assoc, Vol 136, No 11, 1547-1555.
© 2005 American Dental Association
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CLINICAL PRACTICE

JADA Continuing Education

The two-year clinical performance of esthetic restorative materials in noncarious cervical lesions



BANU ÖNAL, D.D.S., Ph.D. and TIJEN PAMIR, D.D.S., Ph.D.


   ABSTRACT
TOP
 ABSTRACT
SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Background. Materials used in restoration of cervical lesions include resin-modified glass ionomer cements, polyacid-modified resin-based composites and resin-based composites. In this study, the authors evaluated the clinical performance of these materials over a two-year period.

Methods. Thirty patients were enrolled in this study. The authors placed in these patients 130 restorations, 24 of which were Vitremer (3M Dental Products, St. Paul, Minn.), 38 were F2000 Compomer (3M Dental Products), 46 were Dyract AP (Dentsply DeTrey, Konstanz, Germany) and 22 were Valux Plus (3M Dental Products). Enamel margins were not beveled, and no mechanical retention was placed. Two independent, calibrated examiners evaluated the restorations at baseline and at one and two years after placement using modified U.S. Public Health Service criteria.

Results. Retention rates at the end of two years were 100 percent for Vitremer, 67 percent for F2000 Compomer, 68 percent for Dyract AP and 70 percent for Valux Plus. The retention rate of Vitremer was significantly higher than that of the others (P < .05). In other categories, however, Valux Plus had the most favorable performance (P < .05). No secondary caries was detected around any restoration.

Conclusion. Vitremer, with its high retention rate, seems to be the most appropriate material for restoration of noncarious cervical lesions, though it does not have the esthetic properties of resin-based composites. All materials used in this study were in need of improvements.

Clinical Implications. Resin-modified glass ionomer cement, polyacid-modified resin-based composite and resin-based composite behaved differently in the restoration of noncarious cervical lesions. Therefore, clinicians should take factors such as esthetic needs and localization into account in selecting materials for such restorations.

Key Words: Noncarious cervical lesion; resin-based composite; resin-modified glass ionomer; polyacid-modified resin-based composite

Noncarious cervical lesions present a significant dental health problem. It is well-recognized that noncarious cervical lesions may be caused by toothbrushing abrasion.1 In the past 20 years, it was hypothesized that the etiologic factor of these wedge-shaped defects was tooth flexure resulting from tensile stress.2 Grippo3,4 used the term "abfraction" for this pathological loss of tooth substance. He presented clinical cases supporting the formation of abfraction lesions but did not present periodontal and toothbrushing histories. On the basis of these opinions, researchers attributed restoration failures of non-carious cervical lesions to abfraction and proposed treatment options.1 However, because of the multifactorial etiology of these lesions—toothbrush abrasion, erosion, stress and so forth—some authors suggested that abfraction alone was insufficient to explain the initiation and progression of these defects.1,5–7 Furthermore, the theory of abfraction is based primarily on a few early engineering models, but the role of the periodontal ligament and its load distribution to surrounding bone are neglected in this explanation.8,9 Whatever the etiology, the restoration of the cervical area is a challenging task for clinicians owing to problems with retention of the restorative materials, mixed cavity margins and esthetic complications.

This study showed the differences in the performance of materials used in the restoration of noncarious cervical lesions.

Cervical areas are morphologically and histologically different from the crown and the root portions of the tooth. Enamel is less firm in this area, because it gradually becomes thinner, and the prisms’ direction changes into a flattened one, in contrast with their undulating direction in crown enamel.10 Mechanical interlocking between enamel and dentin in the cervical area is weaker than that in the other regions of the dentin-enamel junction.11 Furthermore, this area has an aprismal enamel12 and contains less mineral.13 These structural features may adversely affect the performance of the restorative materials used in the cervical area. Therefore, in the restoration of noncarious cervical lesions, a large variety of restorative materials having diverse esthetic and bonding characteristics have been used.

Glass ionomer cements (GICs) are formed by an acid-base reaction of an aqueous polymeric acid and an ion-leachable glass.14 Since these cements bond chemically to enamel and dentin and release fluoride over long periods, they have been considered among the materials used in the restoration of cervical lesions.15 However, some severe shortcomings—such as esthetic inadequacy, inconvenient setting characteristics and low wear resistance against abrasion resulting from toothbrushing—have limited their acceptance for the restoration of cervical lesions.16,17 Resin-based composites (RCs) seem to be a popular alternative to conventional GICs because they exhibit stronger wear resistance and good esthetic properties.18 However, considering the bonding of composites to dentin at the gingival margin, some authors have expressed their concern regarding the longevity of their marginal seal.19,20 Furthermore, multistep-procedure bonding of RC to enamel and dentin often is regarded as technique-sensitive, complicated and time-consuming.21

To overcome the difficulties associated with the restoration of cervical lesions, two categories of materials—resin-modified glass ionomer cement (RM-GIC) and polyacid-modified resin-based composite (PM-RC)—were developed.22 Although these hybrid restoratives originate from combining glass-ionomer and methacrylate-resin technology, their actual composition and application methods differ substantially from those of their counterparts. In the RM-GICs, though a fundamental acid-base reaction still occurs as it does in GICs, the addition of resin components allows light curing and rapid clinical setting.23 However, RM-GICs still have water as an important component and a true glass-ionomer reaction occurs. On the other hand, what is not found in the formulation of PM-RCs is water, and the dominant setting reaction is resinous photopolymerization.22–24 Therefore, PM-RCs should be considered closer to RCs than to GICs. In vitro studies of RM-GICs and PM-RCs showed considerably better mechanical properties and significantly higher bonding strength to enamel and dentin than those of the traditional GICs.25–27 Additionally, it has been claimed that the esthetic properties and clinical handling of these hybrid restorations were even better than those of conventional GICs.28,29 However, in vitro evaluation of new materials does not always reveal their in vivo performance, and clinical testing remains the ultimate proof of effectiveness. In the oral cavity, multiple and mutually interactive clinical variables can affect the performance of tested materials.30,31 Although there are clinical studies evaluating the new materials individually, comparative reports are more essential for determining their clinical effectiveness. We conducted, therefore, a two-year double-blind, randomized clinical trial comparing the performance of one RM-GIC, two PM-RCs and one RC used in the restoration of noncarious cervical lesions. In this study, we used a modified version of the U.S. Public Health Service criteria32 for evaluation.


   SUBJECTS, MATERIALS AND METHODS
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
The participants in this study were 30 patients who were admitted in a two-year period to the outpatient clinics of the restorative dentistry and endodontics department of the Ege University School of Dentistry in Bornova-Izmir, Turkey. We accepted for participation in the study patients who were aged 27 to 64 years and had at least three cervical lesions. Other criteria for inclusion were absence of the following:

– severe medical complications;
– rampant caries or severe chronic periodontitis;
– history of severe active bruxism;
– xerostomia;
– pulpitis and apical periodontitis.

Teeth with vital pulps, however, were necessary for participation.

Volunteers signed a consent form that had been reviewed and approved by the ethical committee of Ege University at the start of the study.

We obtained complete medical and dental histories of the patients, periapical radiographs and photographs of the teeth at the baseline evaluation. We then checked vitality of teeth with a pulp vitality tester (Digitest Pulptester, Parkell Electronics, Farmingdale, N.Y.). We performed all restorative procedures. We did not administer local anesthetic; we isolated teeth with cotton rolls and used a suction device during the restorative process. We placed no retentive grooves or enamel bevels in saucer-shaped lesions (Figure 1AGo). However, we lightly roughened the dentin and enamel walls of the preparation in such cases. After the preparation of operation sites, we placed restorative materials according to manufacturers’ directions. Materials and the application methods used in this study are shown in Table 1Go.



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  		Figure 1. A. Preoperative photograph of saucer-shaped lesion on left first premolar of the mandible. B. The same tooth shown in A, restored with Dyract AP (Dentsply/DeTrey, Konstanz, Germany) after finishing and polishing. This restoration was missed in the two-year follow-up.

 

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  		TABLE 1 MATERIALS AND THEIR APPLICATION METHODS USED IN THIS STUDY.

 
Thirty patients received a total of 130 restorations. In 24 of those, we used the RM-GIC Vitremer (3M Dental Products, St. Paul, Minn.); in 38 we used one PM-RC, F2000 Compomer (3M Dental Products), and in 46 we used another PM-RC, Dyract AP (Dentsply DeTrey, Konstanz, Germany); in 22 we used the RC Valux Plus (3M Dental Products). We applied restorative materials randomly in incisors and premolars of mandibles, maxillas or both. To minimize patient-related effects that might distort the outcome of the study, we allowed no more than three restorations of each restorative material per patient. Most of the patients who participated in this study received restorations composed of all four materials. Distribution of the restorations according to the type of tooth and arch is shown in Table 2Go (page 1551). After placing the restorations, we performed the final finishing and polishing in the same visit using tungsten carbide finishing burs under water cooling and Sof-Lex Contouring and Polishing Discs (3M Dental Products) (Figure 1BGo).


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  		TABLE 2 DISTRIBUTION AND RETENTION OF THE RESTORATIONS.

 
In the double-blind phase of this study, two research assistants served as independent calibrated examiners to evaluate all restorations at three recall times: baseline (within two weeks of placement), one year after placement and two years after placement. Characteristics were recorded according to modified U.S. Public Health Service criteria32 (Table 3Go, page 1551). The examiners resolved disagreements by consensus. To determine the color stability of the materials, one of us (B.O.) took intraoral color photographs immediately after insertion of the restorations and at the recall appointments. We performed statistical analysis of all data using a software program (SPSS 10.0 for Windows, SPSS, Chicago). We used {chi}2 analysis to assess the performance of the tested materials. We compared the baseline scores with those at the recall periods by using the Cochran Q test followed by a McNemar test with Bonferroni adjustment. The significance level was set at P = .05.


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  		TABLE 3 MODIFIED U.S. PUBLIC HEALTH SERVICE CRITERIA.

 

   RESULTS
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
DISCUSSION
 CONCLUSION
 REFERENCES
 
At the one-year recall appointment, two patients who received one restoration of each of the four materials had moved out of the city and had dropped out of the study. We examined 122 restorations in 28 patients at the end of a two-year follow-up period. We observed neither a loss of vitality nor a progressing periapical pathology in any teeth during test periods.

Table 4Go (page 1552) summarizes the clinical evaluation of the tested restorative materials during the two-year period. We found the retention rate of Vitremer to be 100 percent, whereas it was 70 percent for Valux Plus, 68 percent for Dyract AP and 67 percent for F2000 Compomer. Retention failures among teeth groups (Table 2Go) and among material types (Table 4Go, page 1552) were significant (P < .05). Retention failure in the mandibular arch was higher than that in the maxillary arch, and we observed no loss of restoration in maxillary premolars, whereas mandibular incisors exhibited the highest retention failure (Figures 2Go and 3Go, page 1553).


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  		TABLE 4 CLINICAL EVALUATION OF THE MATERIALS USED IN THIS STUDY DURING 24 MONTHS.*

 


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  		Figure 2. Anterior mandibular teeth after receiving restorations.

 


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  		Figure 3. The same teeth as in Figure 2Go two years later.

 
No secondary caries formed beneath the restorations during test periods. However, we found that there were significant differences between the restorative materials in color match, marginal adaptation, marginal discoloration, surface roughness and anatomical form criteria (P < .05) (Figure 4Go, page 1553). On the other hand, among the retained restorations, the RC Valux Plus, exhibited excellent features compared with the others at each recall appointment (P < .05) (Table 4Go) (Figure 5Go, page 1554). Only two RC Valux Plus restorations received Bravo scores for marginal adaptation at the end of the one-year recall period. In spite of its superiority in retention, Vitremer had the lowest Alfa scores in marginal discoloration, marginal adaptation and anatomical form criteria, followed by F2000 Compomer and Dyract AP, respectively (Table 4Go).



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  		Figure 4. Color match of the restorative materials after two years.

 


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  		Figure 5. After two years, a restoration consisting of Valux Plus (3M Dental Products, St. Paul, Minn.) was in excellent condition, while a restoration consisting of F2000 Compomer (3M Dental Products) exhibited a poor clinical performance.

 

   DISCUSSION
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
CONCLUSION
 REFERENCES
 
Retention rates of the materials used in this study did not meet the 5 percent failure rate called for in the ADA guidelines33 for full acceptance after two years of clinical service, with the exception of those of Vitremer. Therefore, we can say that our findings demonstrated the effectiveness of Vitremer (RM-GIC) for the restoration of the cervical lesions. The ionic bonding of Vitremer to the tooth structure seemed most effective when compared with the adhesive bonding of others tested in our study.

Owing to the lack of inherent macromechanical retention in restorations of noncarious cervical lesions, adhesion is the most important factor in retention of such restorations.34 However, the retention is affected by various factors such as tooth flexure, occlusal stress, the character of the dentinal surface and elastic modulus of the restorative materials.

Increased loss of restorations could be attributed to the degradation of the dentinal bond caused by continuing tooth flexure35 and occlusal stress.36,37 These factors affect the types of teeth on the mandibular or maxillary arches differently. Researchers have observed decreased retention of cervical restorations owing to the greater flexure of mandibular teeth.36,38 We observed this in our study as well—particularly the retention failure of mandibular anterior teeth, which was as high as 47 percent, while none of the restorations placed in maxillary premolars were lost (Table 2Go). Our purpose was not to assess the success of materials on different tooth groups taking occlusion into consideration. Therefore, material selection and distribution were completely randomized.

At the conclusion of the study, we judged the localization of the cervical lesions to be important in evaluating the restoration loss. Thus, the evaluation of restorative materials’ success in different teeth groups by means of a controlled study would provide more reliable results.

Another factor affecting retention failure is the elastic modulus of the restorative materials. Heymann and colleagues36 reported that the retention rates for restorations of a material with lower elastic modulus were significantly higher than those of a material with higher elastic modulus. Indeed, in our study, we observed the highest retention rate in the Vitremer group, which had the lowest elastic modulus among the tested materials. It may be more appropriate to use materials with a low elasticity modulus in areas where occlusal forces are concentrated intensively, particularly in mandibular incisors.

Chemically, PM-RCs are close to RCs and different from RM-GICs.24 Therefore, it may be expected that the retention rates of PM-RCs and RCs would be similar. Before placing PM-RCs and RCs, we applied adhesive systems to the lesions as instructed by their manufacturers. Naturally, the bonding manner and strength of the adhesives ultimately affect the success of the restorations. It has been suggested that the acidic primer solution of compomer systems open the dentinal tubules and dissolve the smear layer, and then the resin part of this primer penetrates into the collagen network, forming a hybrid layer.30 On the contrary, some researchers have found that the primer modified only the smear layer, interacting with dentin superficially without any collagen exposure, and, concurrently, the dentinal tubules remained plugged by smear debris. Additionally, it has been noted that the Dyract adhesive system is not acidic enough to form a distinct hybrid layer. 39,40 In our study, we treated enamel and dentin separately with total-etch products (Valux Plus and Scotchbond Multi-Purpose [3M Dental Products]). This application procedure was different from those used for Dyract AP and F2000 Compomer. However, the improvement of retention in the RC was not as high as we had expected. In the literature, the retention rate of various esthetic materials used in treatment of cervical lesions ranged from 69 to 100 percent.30,35,40–46 Success of retention seems to depend on patient selection, localization and shape of the lesions and so forth, as well as the properties of the materials used. Whichever the tested material, a high retention ratio would be expected if it was placed in an area of low concentrated stress. The main reason for inconsistent results among the various studies might be the dissimilar localization of restorations. Results of our study were not in accordance with those of the previous studies that pointed out high retention rates. This might be caused by, for example, the lack of placement of retentive grooves or enamel bevels. Furthermore, the randomized distribution of materials in the tooth groups of the mandibular and maxillary arches might have led to this inconsistent result. Figures 1Go and 2Go indicate the loss of various restorative materials from the mandibular incisors. This situation made us think that failure possibly was related to localization of restorations rather than to material selection.

Vitremer, an RM-GIC, had a high retention rate; however, its esthetic properties were poor. Superior clinical performance was observed for retained RC restorations, whereas the quality of PM-RC restorations and RM-GIC restorations was inferior. These findings agree with the results of previous studies.30,40,43,47 Chemical reactions of the resin matrix, water absorption and the surface characteristics of the set material can be responsible for the alterations in color matches of PM-RC and RM-GIC with the natural teeth.34,43,48

At the baseline, the high percentage of Alfa scores (100 percent) for Vitremer in surface characteristics probably was caused by the application of a surface-protecting glaze to the material. This smooth and glossy surface changed into a rough one at the end of the study. Surface roughness can result from the highly erosive wear of the materials,49 and it leads to external discoloration, since it tends to stain more than does a smoother surface.50

Marginal adaptation is one of the most important criteria to use in evaluating these restorations, because it may lead to clinical micro-leakage. We detected deterioration in marginal adaptation for all of the materials tested. However, RCs showed the lowest rate of nonperfect margins, whereas we observed numerous alterations in the margins in Dyract AP, F2000 Compomer and Vitremer restorations. Marginal breakdown of the restorative materials might result from the nonbeveled margins we used in this study. However, we did not observe secondary caries under any restoration.

In our study, we applied strict standards to evaluation of the restorations. We gave Alfa ratings only to excellent restorations. Therefore, many Bravo scores are the result of this strict observation rule, and differences between Alfa and Bravo scores were only marginal. Since Alfa and Bravo scores both indicate "clinical acceptability," all retained restoratives used in this study are within acceptable limits. The results of our study agree with those of previous studies,21,40 in that the materials used in the cervical restorations behaved differently in regard to all clinical evaluation criteria. According to the findings in this study, Vitremer, with its high retention rate, seems to be an appropriate material in the treatment of cervical lesions, though it needs clinical improvement. The restoration of cervical lesions, however, seems to be a continuing problem. Since the retention rates observed in this study were different in anterior or posterior teeth of the maxillary and mandibular jaws, we are planning, as a complementary study, to evaluate the effect of occlusion and localization (maxillary or mandibular jaw, anterior or posterior teeth) on the performance of restorative materials used in the treatment of noncarious cervical lesions.


   CONCLUSION
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
REFERENCES
 
This study showed the differences in the performance of restorative materials within two years of clinical service. Only Vitremer (an RM-GIC) provided excellent retention rates, satisfying the ADA standard of a 5 percent failure rate, whereas Valux Plus (an RC) exhibited the best clinical properties in the remaining evaluation criteria. However, compomer systems (F2000 Compomer and Dyract AP) had neither the esthetic properties of the RC nor the retention rates of the RM-GIC.


   FOOTNOTES
 

Dr. Önal is a professor, Ege University, School of Dentistry, Department of Restorative Dentistry and Endodontics, Bornova-Izmir, Turkey.


Dr. Pamir is an assistant professor, Ege University, School of Dentistry, Department of Restorative Dentistry and Endodontics, . 35100 Bornova-Izmir, Turkey, e-mail "tijenpamir{at}yahoo.com". Address reprint requests to Dr. Pamir.


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

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