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J Am Dent Assoc, Vol 137, No 11, 1529-1536.
© 2006 American Dental Association
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CLINICAL PRACTICE

JADA Continuing Education

A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach

Results at 24 months



Nazan Kocatas Ersin, PhD, DDS, Umit Candan, DDS, Arzu Aykut, DDS, Özant Önçag, PhD, DDS, Cemal Eronat, PhD, DDS and Timur Kose, PhD, DDS


   ABSTRACT
TOP
 ABSTRACT
SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Background. The authors evaluated the 24-month performance of a packable resin-based composite/dentin bonding system and a high-viscosity glass ionomer cement (GIC) in restorations placed in primary molars with the atraumatic restorative treatment (ART) approach.

Methods. Three dentists placed 419 restorations in 219 children aged 6 through 10 years who had bilateral matched pairs of carious posterior Class I and II primary teeth. They used a split-mouth design to place the two materials, which were assigned randomly to contralateral sides. The authors evaluated the restorations according to U.S. Public Health Service Ryge criteria.

Results. After 24 months, 96.7 percent of the Class I GIC restorations and 91 percent of the resin-based composite restorations survived, while the success rates for the Class II restorations were 76.1 percent and 82 percent for the GIC and resin-based composite restorations, respectively. The survival rate of the Class II resin-based composite restorations was 5.9 percent higher than that of the GIC restorations at the 24-month evaluation, but this difference was not statistically significant. However, the study results showed a statistically significant difference in survival rates between Class I and II restorations for both materials.

Conclusion and Clinical Implications. The two-year clinical performance of both materials was satisfactory for the restoration of Class I and II primary molars using the ART approach.

Key Words: Atraumatic restorative treatment; high-viscosity glass ionomer cement; packable resin-based composite/dentin bonding system

A traumatic restorative treatment (ART) is a minimally invasive technique for removing soft and demineralized carious dental tissues using hand instruments.1 It was developed for the treatment of caries in areas of the world with limited resources, but the procedure is gaining acceptance in developed countries for the treatment of early childhood caries, especially in young children with rampant caries who cannot cooperate sufficiently to undergo conventional restorative treatment.2,3

Glass ionomer cement (GIC) is the material of choice in this approach, because of its caries-protective effect through the release of fluoride.1,3,4 Several authors have reported that it has antibacterial properties, because of its release of fluoride, which also potentiates remineralization, promoting a hardening of the layer of demineralized dentin left after lesion curettage.2,5,6 However, most of these studies were carried out in vitro, and a systematic review of clinical studies did not reveal any conclusive evidence about its caries-inhibitory effect.7 Moreover, many studies conveyed doubts about whether GIC has antibacterial properties regarding the viability of residual bacteria in carious dentin under GIC restorations.8,9 Another concern about GIC is its possible microleakage and poor physical properties, which result in more wear in stress-bearing occlusal cavities10,11; in addition, its use is restricted to small Class I cavities.

Recently, several new high-viscosity GICs with improved handling and physical properties have been marketed for the ART approach. Compared with conventional GIC, these new GICs have been reported to have better physical properties in Class I ART restorations,2,4 but more data are needed regarding the clinical performance of Class II restorations. Moreover, some clinical problems have become apparent with these new GICs, including the loss of restorations from shallow and nonmacromechanically retentive preparations and bulk fractures of multisurface restorations.12

Research is needed to investigate a variation of ART using more durable materials. Because the success of ART depends to some extent on the restorative material used, researchers have recommended that clinical trials be conducted into the use of adhesive materials with physical properties that are superior to those of the high-viscosity GICs.13,14 Therefore, we decided to test whether a resin-based composite was a suitable restorative material to use with the ART approach under field conditions and could provide optimal clinical performance over the long term.

The purpose of our study was to evaluate the applicability and effectiveness of a resin-based composite/dentin bonding system and a high-viscosity GIC using the ART approach in primary teeth.


   SUBJECTS, MATERIALS AND METHODS
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Study population. In 2003, three of the authors (N.K.E., U.C., A.A.) conducted an epidemiologic study in 10 primary schools (grades 1 through 3) in the rural areas of Izmir, Turkey. Two calibrated examiners (Ö.Ö., C.E.) examined teeth under daylight using a probe and mirror and recorded caries and plaque scores according to the criteria described by the World Health Organization15 and Silness and Löe,16 respectively. The ages of patients ranged from 6 through 10 years, with a mean (± standard deviation [SD]) age of 8.07 (± 1.51) years. The baseline assessment showed a mean (± SD) decayed or filled primary teeth (dft) index of 5.08 (± 2.66) and a decayed, missing or filled permanent teeth (DMFT) index of 2.13 (± 1.2). The children’s mean plaque score was 1.54 (± 0.65).

We informed the children’s parents about the program and obtained written informed consent from them before including their children in the study. The Ethical Committee of Ege University, Izmir, approved the study.

Restorative techniques. We selected for the study patients who had a matched pair of primary molars with an occlusal or approximal carious lesion of similar size. We used a split-mouth design for the two restorative materials. The inclusion criteria also consisted of dentinal lesions that had an opening wide enough for the smallest excavator to enter.

Three of the authors (N.K.E., U.C., A.A.) placed a total of 419 restorations in 219 children using the ART approach. They treated the children in classrooms, where they lay on desks in a supine position to receive treatment. The dentists used a portable clinical light for illumination. They removed the carious lesions using the ART technique only, according to the recommendations of Frencken and Holmgren.1 The clinicians used conventional optical and tactile criteria to determine the thoroughness of caries removal after cavity preparation.

Each patient received two restorations. One of the two materials used was Fuji IX GP (GC Europe NV, Leuven, Belgium), a high-viscosity GIC marketed for ART. The second material used was a packable resin-based composite (SureFil, Dentsply/DeTrey GmbH, Konstanz, Germany), along with a dentin bonding system (Xeno III, Dentsply/DeTrey GmbH) (Table 1Go). The dentists randomly selected the restorative material to be placed. They mixed and handled the materials, as well as treated dentin, in accordance with the manufacturers’ instructions.


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  		TABLE 1 Characteristics of restorative materials.

 
High-viscosity GIC restorations. Before placing the GIC restorations, the dentist prepared the cavity and cleaned the adjacent enamel with a polyacrylic conditioner (GC Dentin Conditioner, GC Europe). After 10 to 15 seconds, he or she removed the conditioner with water-moistened cotton pellets before lightly drying the teeth with sterile pellets. After mixing the cement, the dentist placed it in the cavity (using a gloved finger lightly lubricated with petroleum jelly) and pressed it into any adjacent fissures. After the restorations set initially and the dentist perfomed occlusal adjustment, he or she applied cavity varnish (Fuji Varnish) over them.

Resin-based composite restorations. Using an applicator tip, the dentist applied a one-step self-etching adhesive (Xeno III) to the subject’s cavities and left it there undisturbed for 20 seconds (after mixing one drop of the primer and adhesive for five seconds and light-curing the mixture for 10 seconds). The dentist then placed the packable resin-based composite in layers that were approximately 2 millimeters thick. He or she light cured each increment for 40 seconds with a light-emitting diode curing light. The clinician used cotton wool rolls to control the moisture. He or she applied a calcium hydroxide compound (Dycal, Dentsply/DeTrey) in deep dentinal lesions for pulpal protection but excluded teeth with pulpal exposure. The clinician used a matrix for Class II restorations to maintain tight adaptation of the restorations.

Two blinded examiners (Ö.Ö., C.E.) who were not involved in the placement of the restorations evaluated the restorations at six, 12 and 24 months. Cohen’s kappa values for intraexaminer and interexaminer reliability after repeated examinations of 10 percent of the study group were 0.91 and 0.82, respectively. The examiners performed the examinations during regular school hours in classrooms using mirrors with sickle-shaped probes and artificial headlight illumination. The examiners used the U.S. Public Health Service (USPHS) Ryge criteria17 to evaluate the restorations (Table 2Go). After evaluating the restoration, the examiners also recorded the location and type of tooth.


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  		TABLE 2 Description of USPHS* criteria.{dagger}

 
Three of the authors (N.K.E., U.C., A.A.) entered the data on spreadsheets and analyzed them using statistical software (SPSS 13.0, SPSS, Chicago). They estimated cumulative survival rates using the Kaplan-Meier method and log-rank test. In addition, they used the McNemar test to evaluate the effects of variables such as tooth location, tooth type and operator effects on the survival of restorations. To compare the restorative materials according to the USPHS criteria, they used the McNemar test and the Wilcoxon signed rank test. We considered differences to be significant at P < .05.


   RESULTS
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
DISCUSSION
 CONCLUSION
 REFERENCES
 
The examiners evaluated 180 schoolchildren (344 restorations) after 24 months of follow-up; the dropout rate was 17.8 percent. The reasons for participants’ dropping out were irregular school attendance or being transferred to another school.

Nineteen children received only one ART restoration owing to the exclusion of the matched tooth because of pulpal exposure; the remaining children received two restorations. By the end of the 24-month follow-up, 19 restored primary molars had exfoliated, and we did not consider these to be true failures.

Table 3Go (page 1533) shows the distribution of the restorations according to their locations and tooth type; we found that these variables had no significant effect on the survival rates of the restorations.


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  		TABLE 3 Distribution of restorations according to location and tooth type.

 
The six-month cumulative survival rate for the ART restorations was 100 percent for the Class I GIC and resin-based composite restorations and 90.2 and 92.3 percent, respectively, for Class II restorations. The 12-month survival rates for Class I restorations were 100 and 98 percent for the GIC and resin-based composite restorations, respectively, while the survival rates for Class II restorations were 83.1 and 87.5 percent for the two materials, respectively.

The 24-month results for Class I restorations were 96.7 and 91 percent for the GIC and resin-based composite materials, respectively, while the success rates for Class II restorations were 76.1 and 82 percent, respectively, for the two materials.

The survival rate for the resin-based composite restorations in Class II teeth was 5.9 percent higher than it was for the GIC restorations over the 24-month evaluation period, but the difference was not statistically significant (P = .348). In addition, we found no statistically significant difference between the total number of Class I restorations that survived in the GIC or resin-based composite groups after 24 months (P = .095). However, we found significant differences between Class I and Class II restorations in the two groups (P = .0001 for the GIC restorations and P = .037 for the resin-based composite restorations); Class I restorations had statistically better survival rates than did the Class II restorations over the 24-month period. Table 4Go shows the cumulative survival percentages for the two restorative materials according to class at six, 12 and 24 months.


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  		TABLE 4 Cumulative survival of restorations in primary molars using the ART* approach.

 
Table 5Go (page 1534) shows the distribution of the retained restorations according to the USPHS Ryge categories. The results showed no statistically significant differences between the two materials with regard to each criterion. We found no operator effect with regard to the survival rates of the restorations (P = .338 for the resin-based composite restorations and P = .205 for the GIC restorations).


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  		TABLE 5 Status of the ART* restorations according to USPHS{dagger} criteria at the 24-month evaluation.{ddagger}

 

   DISCUSSION
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
CONCLUSION
 REFERENCES
 
The ART technique was developed in the mid-1980s for nonindustrialized countries whose populations are of low socioeconomic status and in which there is no electricity. In recent years, the technique has been gaining wider acceptance in the dental treatment of young, uncooperative children.1 However, further research is needed to discover an adhesive material with physical properties that are superior to those of high-viscosity GICs, because the survival rates of multiple-surface GIC restorations placed with ART are reported to be low.4,18 We conducted this study to assess whether Class I and II restorations composed of a packable resin-based composite/dentin bonding system would have a higher retention rate in primary teeth compared with those composed of a high-viscosity GIC under field conditions.

In recent years, resin-based composites have gained more acceptance in the treatment of primary molars.19,20 Several studies have found that they have better physical and clinical properties compared with conventional GICs,21,22 and some reports have suggested that resin-based composites and the adhesive systems used with them might have a longer survival time than GICs when used for Class II restorations in primary molars.23,24

Hickel and colleagues22 found that the annual failure rates in stress-bearing cavities of primary molars were 0 to 25.8 percent for GIC restorations and 0 to 15 percent for resin-based composite restorations. Conversely, Pascon and colleagues25 evaluated the clinical performance of resin-based composite and compomer restorations in primary molars and found that the resin-based composite exhibited the lowest survival rates at 24 months. The authors indicated that clinicians should be cautious about placing resin-based composite restorations in primary molars.

In our study, we found the resin-based composite to be satisfactory for Class I and II restorations in primary teeth at the 24-month recall examination. The survival rate of the resin-based composite was 5.9 percent higher than that of the GIC for Class II restorations, but this difference was not statistically significant. However, it is possible that a statistically significant difference might be apparent over a longer evaluation period.

We chose to place a packable resin-based composite because of its physical properties, such as wear resistance, reduced polymerization shrinkage, surface hardness and resistance to fracture. Its compressive, tensile and flexural strengths also are comparable with those of conventional resin-based composites.26 Turkun and colleagues27 found that a packable resin-based composite was successful in Class I and II restorations in permanent teeth after two years of clinical service. Poon and colleagues28 showed that a packable resin-based composite was satisfactory in Class I and moderately sized Class II restorations in permanent teeth after 3.5 years. However, there have been no published data, to our knowledge, regarding the clinical performance of a packable resin-based composite in primary molars. We also might be able to attribute our successful results to the one-step adhesive system used in this study; it eliminated the need for etching and simplified the treatment procedure, which reduced the sensitivity of the technique.

Smales and Yip18 and Yu and colleagues29 found that one-year survival rates for GIC restorations placed in Class I cavities of primary molars using ART were between 80 and 100 percent; the one-year survival rates for Class II restorations were between 55 and 75 percent. However, Marks and colleagues30 reported a 92 percent one-year survival rate for multiple-surface high-viscosity GIC restorations in the primary dentition, and Rutar and colleagues31 reported a 93 percent two-year survival rate for capsulated GIC restorations. Taifour and colleagues32 reported a three-year cumulative survival rate for single-surface GIC restorations in primary teeth of 85.2 percent and 49.3 percent for multiple-surface restorations placed with the ART technique.

In our study, we found a 24-month success rate for Class I restorations of more than 90 percent for both restorative materials, which is in agreement with some studies4,29,32 and higher than the rate for some earlier studies.33,34 The success rate for Class II restorations was 76.1 percent for the GIC and 82 percent for the packable resin-based composite, which are significantly lower rates than those for Class I restorations. These results are consistent with those of other ART studies, which showed that multiple-surface GIC restorations generally have lower survival rates than do single-surface GIC restorations.14,18

To date, only one study has been reported regarding compomer restorations placed with ART,35 and no study has been reported regarding resin-based composite restorations placed with this method. In accordance with the one-year field study results of Louw and colleagues,35 who found that compomer restorations placed with the ART technique were more successful than GIC restorations, we found that resin-based composite restorations in Class II primary molars exhibited higher survival rates than GIC restorations, although the difference was not statistically significant.

The predominant failure characteristic of Class I and II restorations for both materials was the loss of the restoration. This pattern of failure for ART restorations also was reported by Lo and colleagues4 after two years of clinical service. We rarely observed caries at the margin. In addition, we rarely observed secondary caries, which is a major cause of restoration failure.36,37 Two ART studies also reported this latter observation.34,38 The surface texture, anatomical form, marginal discoloration and integrity of all restorations placed in our study were satisfactory for both materials.


   CONCLUSION
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
REFERENCES
 
Within the limitations of this study, we found that the GIC and packable resin-based composite restorative materials placed with the ART approach under field conditions exhibited satisfactory results after two years of clinical service. There was no statistically significant difference between the materials. Class I restorations experienced statistically better survival rates than did Class II restorations for both materials. On the basis of these study results, clinicians could recommend the use of a packable resin-based composite/dentin bonding system as an alternative to GIC for Class II restorations placed with the ART technique. However, longer-term investigations are required to monitor the survival rate of Class II resin-based composite restorations.


   FOOTNOTES
 

Dr. Ersin is a senior research assistant, Department of Pediatric Dentistry, Ege University, Bornova-Izmir, 35100 Turkey, e-mail "nazan.ersin{at}ege.edu.tr". Address reprint requests to Dr. Ersin.


Dr. Candan is a research assistant, Department of Pediatric Dentistry, Ege University, Izmir, Turkey.


Dr. Aykut is a research assistant, Department of Pediatric Dentistry, Ege University, Izmir, Turkey.


Dr. Önçag is a professor, Department of Pediatric Dentistry, Ege University, Izmir, Turkey.


Dr. Eronat is a professor, Department of Pediatric Dentistry, Ege University, Izmir, Turkey.


Dr. Kose is an associate professor, Department of Computer Engineering, Ege University, Izmir, Turkey.


The authors thank GC Europe NV, Leuven, Belgium, for providing restorative materials for this study.


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

  1. Frencken JE, Holmgren CJ. Atraumatic restorative treatment (ART) for dental caries. Nijmegen, Netherlands: STI; 1999.

  2. Smales RJ, Gao W. In vitro caries inhibition at the enamel margins of glass ionomer restoratives developed for the ART approach. J Dent 2000;28(4):249–56.[Medline]

  3. Carvalho CK, Bezerra AC. Microbiological assessment of saliva from children subsequent to atraumatic restorative treatment (ART). Int J Paediatr Dent 2003;13(3):186–92.[Medline]

  4. Lo EC, Luo Y, Fan MW, Wei SH. Clinical investigation of two glass-ionomer restoratives used with the atraumatic restorative treatment approach in China: two-years results. Caries Res 2001;35(6):458–63.[Medline]

  5. Herrera M, Castillo A, Baca P, Carrion P. Antibacterial activity of glass-ionomer restorative cements exposed to cavity-producing microorganisms. Oper Dent 1999;24(5):286–91.[Medline]

  6. Duque C, Negrini Tde C, Hebling J, Spolidorio DM. Inhibitory activity of glass-ionomer cements on cariogenic bacteria. Oper Dent 2005;30(5):636–40.[Medline]

  7. Randall RC, Wilson NH. Glass-ionomer restoratives: a systematic review of a secondary caries treatment effect. J Dent Res 1999;78(2):628–37.[Abstract/Free Full Text]

  8. Weerheijm KL, Groen HJ. The residual caries dilemma. Community Dent Oral Epidemiol 1999;27(6):436–41.[Medline]

  9. Foley J, Blackwell A. In vivo cariostatic effect of black copper cement on carious dentine. Caries Res 2003;37(4):254–60.[Medline]

  10. Jumlongras D, White GE. Bond strengths of composite resin and compomers in primary and permanent teeth. J Clin Pediatric Dent 1997;21(3):223–9.

  11. Mount GJ. Glass ionomers: a review of their current status. Oper Dent 1999;24(2):115–24.[Medline]

  12. Smales RJ, Yip HK. The atraumatic restorative treatment (ART) approach for the management of dental caries. Quintessence Int 2002;33(6):427–32.[Medline]

  13. Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent 1996;56(3 special number):135–40.[Medline]

  14. Lo EC, Holmgren CJ. Provision of atraumatic restorative treatment (ART) restorations to Chinese pre-school children: a 30-month evaluation. Int J Paediatr Dent 2001;11(1):3–10.[Medline]

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  16. Silness J, Löe H. Periodontal disease in pregnancy, part II: correlation between oral hygiene and periodontal condition. Acta Odontol Scand 1964;22:121–35.[Medline]

  17. Ryge G. Clinical criteria. Int Dent J 1980;30(4):347–58.[Medline]

  18. Smales RJ, Yip HK. The atraumatic restorative treatment (ART) approach for primary teeth: review of literature. Pediatr Dent 2000;22(4):294–8.[Medline]

  19. Cunha RF. A thirty months clinical evaluation of a posterior composite resin in primary molars. J Clin Pediatr Dent 2000;24(2):113–5.[Medline]

  20. Attin T, Opatowski A, Meyer C, Zingg-Meyer B, Buchalla W, Monting JS. Three-year follow up assessment of Class II restorations in primary molars with a polyacid-modified composite resin and a hybrid composite. Am J Dent 2001;14(3):148–52.[Medline]

  21. Almuammar MF, Schulman A, Salama FS. Shear bond strength of six restorative materials. J Clin Pediatr Dent 2001;25(3):221–5.[Medline]

  22. Hickel R, Kaaden C, Paschos E, Buerkle V, Garcia-Godoy F, Manhart J. Longevity of occlusally-stressed restorations in posterior primary teeth. Am J Dent 2005;18(3):198–211.[Medline]

  23. Rastelli FP, de Sousa Vieira R, Rastelli MC. Posterior composite restorations in primary molars: an in vivo comparison of three restorative techniques. J Clin Pediatr Dent 2001;25(3):227–30.[Medline]

  24. Papathanasiou AG, Curzon ME, Fairpo CG. The influence of restorative material on the survival rate of restorations in primary molars. Pediatr Dent 1994;16(4):282–8.[Medline]

  25. Pascon FM, Kantovitz KR, Caldo-Teixeira AS, et al. Clinical evaluation of composite and compomer restorations in primary teeth: 24-month results. J Dent 2006;34(6):381–8.[Medline]

  26. Peumans M, Van Meerbeek B, Asscherickx K, et al. Do condensable composites help to achieve better proximal contacts? Dent Mater 2001;17(6):533–41.[Medline]

  27. Turkun SL. Clinical evaluation of a self-etching and a one-bottle adhesive system at two years. J Dent 2003;31(8):527–34.[Medline]

  28. Poon EC, Smales RJ, Yip KH. Clinical evaluation of packable and conventional hybrid posterior resin-based composites: results at 3.5 years. JADA 2005;136(11):1533–40.[Abstract/Free Full Text]

  29. Yu C, Gao XJ, Deng DM, Yip HK, Smales RJ. Survival of glass ionomer restorations placed in primary molars using atraumatic restorative treatment (ART) and conventional cavity preparations: 2-year results. Int Dent J 2004;54(1):42–6.[Medline]

  30. Marks LA, van Amerongen WE, Borgmeijer PJ, Groen HJ, Martens LC. Ketac Molar versus Dyract Class II restorations in primary molars: twelve month clinical results. ASDC J Dent Child 2000;67(1):37–41.[Medline]

  31. Rutar J, McAllan L, Tyas MJ. Clinical evaluation of a glass ionomer cement in primary molars. Pediatr Dent 2000;22(6):486–8.[Medline]

  32. Taifour D, Frencken JE, Beiruti N, van ‘t Hof MA, Truin GJ. Effectiveness of glass-ionomer (ART) and amalgam restorations in the deciduous dentition: results after 3 years. Caries Res 2002;36(6):437–44.[Medline]

  33. Frencken JE, Songpaisan Y, Phantumvanit P, Pilot T. An atraumatic restorative treatment (ART) technique: evaluation after one year. Int Dent J 1994;44(5):460–4.[Medline]

  34. Frencken JE, Makoni F, Sithole WD. ART restorations and glass ionomer sealants in Zimbabwe: survival after 3 years. Community Dent Oral Epidemiol 1998;26(6):372–81.[Medline]

  35. Louw AJ, Sarvan I, Chikte UM, Honkala E. One-year evaluation of atraumatic restorative treatment and minimum intervention techniques on primary teeth. SADJ 2002;57(9):366–71.[Medline]

  36. Wilson NH, Burke FJ, Mjor IA. Reasons for placement and replacement of restorations of direct restorative materials by a selected group of practitioners in the United Kingdom. Quintessence Int 1997;28(4):245–8.[Medline]

  37. Mjor IA. The reasons for replacement and the age of failed restorations in general dental practice. Acta Odontol Scand 1997;55(1):58–63.[Medline]

  38. Frencken JE, Makoni F, Sithole WD, Hackenitz E. Three-year survival of one-surface ART restorations and glass-ionomer sealants in a school oral health programme in Zimbabwe. Caries Res 1998;32(2):119–26.[Medline]




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