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J Am Dent Assoc, Vol 134, No 12, 1581-1589.
© 2003 American Dental Association
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RESEARCH

COVER STORY
JADA Continuing Education

Clinical evaluation of packable and conventional hybrid resin-based composites for posterior restorations in permanent teeth

Results at 12 months



KEVIN H.-K. YIP, B.D.S., M.Ed., M.Med.Sc., Ph.D., BELINDA K.M. POON, B.D.S., B.Dent.Sc., M.D.S., FREDERICK C.S. CHU, B.D.S.(Hons), M.Sc., ERIC C.M. POON, B.D.S., FIONA Y.C. KONG, B.D.S. and ROGER J. SMALES, M.D.S.(Hons) ,D.D.SC.


   ABSTRACT
TOP
 ABSTRACT
SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Background. Packable resin-based composites and simplified resin bonding systems are marketed to offer many advantages over conventional posterior hybrid composites and total-etch bonding systems. The authors conducted a study to evaluate the initial clinical performances of a packable and a conventional hybrid resin-based composite used with a simplified bonding system.

Methods. A total of 57 Class I and 45 Class II restorations were placed in the permanent teeth of 65 adult patients. The carious lesions were restored with either packable resin-based composite (SureFil, Dentsply DeTrey GmbH, Konstanz, Germany) or conventional hybrid resin-based composite (SpectrumTPH, Dentsply DeTrey GmbH), using a resin adhesive (Non-Rinse Conditioner and Prime & Bond NT, both manufactured by Dentsply DeTrey GmbH). The authors evaluated the restorations using U.S. Public Health Service-Ryge modified criteria (in which Alfa is the highest rating) and by using color transparencies and die stone replicas.

Results. Three SureFil restorations failed before their baseline evaluation. There were no failures among the 78 SpectrumTPH restorations evaluated at 12 months. For both resin-based composites, Alfa ratings were 90 percent or higher for marginal discoloration, anatomical form, surface texture and surface staining. Lower percentages of restorations were rated Alfa for color match, marginal integrity and gingival health. Occasional mild postoperative sensitivity was reported for four SureFil restorations and one SpectrumTPH restoration. The mean occlusal wear rate was 38 micrometers for the larger SureFil restorations and 25 µm for the smaller SpectrumTPH restorations.

Conclusions. The 12-month clinical performances of the two restorative materials were satisfactory and not significantly different for each of the parameters evaluated.

Clinical Implications. A packable and a conventional hybrid resin-based composite placed with a simplified bonding system in posterior permanent teeth showed satisfactory and similar results after 12 months.

The use of posterior resin-based composites is increasing, despite their higher costs and shorter longevity in comparison with amalgam and gold.1,2 Packable or high-density posterior resin-based composites are marketed extensively as amalgam substitutes. Their handling properties are claimed to be similar to those of dental amalgam, in terms of allowing faster placement and tighter interproximal contacts with Class II restorations than are possible with conventional posterior resin-based composites.3 The physical properties of packable composites—such as wear resistance, surface hardness, fracture toughness, and compressive, tensile and flexural strengths—are comparable with those of conventional resin-based composites.4–10 Overall, their polymerization shrinkage also is comparable.11,12 Therefore, it has been assumed that a pack-able composite (such as SureFil, Dentsply DeTrey GmbH, Konstanz, Germany) will perform at least as well as a conventional minifilled hybrid composite (such as SpectrumTPH, Dentsply DeTrey GmbH).

Both types of composite placed with a simplified bonding system in posterior permanent teeth showed satisfactory and similar results after 12 months.

Prime & Bond NT, or PBNT, Dual Cure Adhesive (Dentsply DeTrey GmbH), is a self-priming resin adhesive that contains nanofillers approximately 7 nanometers in diameter. The manufacturer claims that it provides superior bond strengths to enamel and dentin when compared with other current so-called fifth-generation bonding agents.13,14 The associated use of a Non-Rinse Conditioner, or NRC (Dentsply DeTrey GmbH), simplifies the restoration placement technique. The reduction of treatment steps not only saves time, but also should result in less postoperative sensitivity.15 In addition, the adhesive system appears to have adequate in vitro enamel and dentin bond strengths for clinical success.16–20

We undertook a study to compare the clinical performance of SureFil and SpectrumTPH when used with the NRC and PBNT bonding system for posterior restorations in permanent teeth. The null hypothesis we were testing was that there are no significant differences between the clinical performances of the two restorative materials when they are placed using a simplified bonding system.


   SUBJECTS, MATERIALS AND METHODS
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Subjects. We recruited 65 healthy adult subjects, 16 male and 49 female, with a mean age of 30 years (aged 18 to 66 years), from among patients receiving care at The Prince Philip Dental Hospital, Hong Kong. Each volunteer subject signed an informed consent form before participating in the study. Approval for the clinical trial was obtained from the ethics committee of the hospital’s faculty of dentistry.

We required each subject to have no more than four vital permanent premolars and/or molars with clinically or radiographically detectable primary caries that required restoration. The selected teeth had to have opposing teeth present. Otherwise, as in general practice, there were no other constraints. Table 1Go shows the components of the materials used; Table 2Go shows the distribution of the subjects and of the restorations placed and evaluated. One subject received four restorations, 26 received two restorations each, and four subjects received three restorations each. Thirty-four subjects received only one restoration each. No subject received both restorative materials.


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  		TABLE 1 RESTORATIVE MATERIALS USED IN THE STUDY.

 

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  		TABLE 2 NUMBERS OF SUBJECTS, WITH RESTORATIONS PLACED AND EVALUATED.

 
Operative procedure. The dentists on the research team (K.H.-K.Y., B.K.M.P., F.C.S.C.) made the shade selection before the restorative procedure while the teeth were moist. With few exceptions, all teeth were treated by one of the three dentists under local anesthesia and isolated with rubber dam. Cavity preparation involved conservative adhesive designs. For deep cavities, the dentists placed a light-cured glass ionomer cement liner (Fuji Lining LC, GC Corporation, Tokyo) under the restorations to protect the pulp. For Class II restorations, the dentists used metal matrix bands (Tofflemire, Teledyne Waterpik Technologies, Fort Collins, Colo.) and wooden wedges. They removed excess water from the cavities with a soft airblow, leaving a moist surface.

In each case, the dentist applied NRC to the preparation surfaces for 20 seconds before removing excess liquid with a gentle air blow. He or she then applied PBNT liberally and left it for 20 seconds before also removing excess solvent with a gentle air blow. He or she checked the surfaces to confirm that they were uniformly glossy before light curing them for 10 seconds.

The dentist placed SureFil and SpectrumTPH sequentially in two separate groups of subjects. Initially, he or she applied a thin layer of composite to the exposed dentin in the preparation and cured it for 20 seconds while holding any matrix band firmly against the adjacent proximal tooth contact. Increments of 2 to 3 millimeters were cured for 40 seconds. After removing the matrix band, the dentist directed additional curing toward the buccal and lingual embrasures. A standard halogen light-curing unit (Spectrum 800, Dentsply Caulk, Milford, Del.) was used for curing the resin adhesive and the restorations.

The dentists finished the restorations immediately after curing, using multifluted carbide finishing burs for contouring and removal of excess restorative material. They achieved additional refinements by using finishing and polishing points and discs (Enhance Finishing and Polishing Points and Discs, Dentsply Caulk). A final luster was achieved by applying polishing pastes (Prisma-Gloss or Prisma-Gloss Extrafine, Dentsply Caulk).

Direct evaluations. Two clinical assessors (E.C.M.P., F.Y.C.K.) evaluated the restorations within two weeks of their placement at baseline and at the subsequent 12-month review. They worked with the principal investigator (K.H.-K.Y.) to establish evaluation criteria, and the principal investigator trained them before the baseline evaluation. All evaluations were carried out under a dental operating light, using front-surfaced mouth mirrors and dental explorers. The assessors directly evaluated restoration retention, color match, marginal discoloration, marginal integrity, recurrent caries (cavitation or softness to probing), anatomical form, surface texture and surface staining according to United States Public Health Service, or USPHS, -Ryge modified criteria.21 (These criteria are as follows: Alfa restorations are of satisfactory quality and meet all clinical standards with a range of excellence. Bravo restorations are also satisfactory, although not ideal, with a range of acceptability. Charlie restorations are not of acceptable quality and should be replaced or corrected for preventive reasons.) Gingival bleeding adjacent to Class II restorations was recorded using World Health Organization plastic Community Periodontal Index probes.22 The assessors recorded this parameter or factor as either absent or present, as they did with restoration expansion and postoperative sensitivity (both of which were determined by the two assessors who interviewed the subjects and by clinical examination).

Indirect evaluations. Either the dentists or the assessors took color transparencies at x1.0 magnification of the carious teeth before treatment, after restoration, at baseline and at 12 months after restoration placement to confirm any color mismatch and marginal or surface discoloration observed clinically.

Either the dentists or the assessors made an impression of each restored tooth with polyvinyl siloxane impression material (Aquasil, Dentsply Caulk) after cavity preparation, and after restoration at baseline and at 12 months. Dental technicians at The Prince Philip Dental Hospital, Hong Kong, poured the impressions in a reinforced stone, and the assessors then evaluated the replicas against a standard semiquantitative ivorine tooth model (Rheinberger, Ivoclar-Vivadent, Schaan, Lichtenstein) to estimate the restorations’ amount of occlusal wear. The cavosurface margin showing the most severe wear or material loss determined the rating given for each restoration. The assessors confirmed the evaluations of interproximal contacts, marginal integrity and any expansion of the restorations from the stone replicas. They also measured the approximate dimensions of the cavity preparations from the stone replicas by using a graduated metal probe. They made measurements at the cavosurface margins for restoration width and length, and from the deepest region of the pulpal floor to the cavosurface margins for restoration depth.

Statistical analysis. The assessors entered all data into a spreadsheet program (Excel Version 7.0, Microsoft, Redmond, Wash.). Another of the investigators (R.J.S.) analyzed the data using statistical software (Prism Package, Version 2.01, GraphPad, San Diego). He used the Fisher exact test and the Student t test to determine statistical differences between the two composites. We considered a probability value of P ≤ .05 to be statistically significant. The investigator calculated cumulative failures using the formula given in the American Dental Association Acceptance program guidelines for dentin and enamel adhesive materials.23


   RESULTS
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
DISCUSSION
 CONCLUSION
 REFERENCES
 
Twelve subjects who were seen at baseline did not return for the 12-month evaluation. These people accounted for restoration dropouts of 22 percent for SureFil and 18 percent for SpectrumTPH over 12 months. Table 2Go shows the numbers of restorations that were available for evaluation. There was no significant difference between the two composites for restoration class numbers at 12 months (Fisher exact test, P = .24).

Four molar teeth with large SureFil restorations placed in deep Class II preparations required further treatments before they were evaluated at baseline. Two restorations that failed because of bulk fracture were replaced by amalgam restorations in one subject, and one failed cracked restoration was replaced by a cast gold onlay in another subject. A third subject required endodontic therapy for one tooth in which the restoration originally was intact. Shortly after the baseline evaluations, two additional subjects each had one tooth with similar deep molar preparations and originally intact restorations that developed a need for endodontic therapy.

The three intact SureFil restorations in teeth requiring endodontic therapy should be classified as apparent and not true restorative material failures, as the pulpal problems were not directly related to the resin-based composite material. The other three failed SureFil restorations that required replacements before their baseline evaluations resulted in a cumulative failure rate after 12 months of 6.3 percent. None of the SpectrumTPH restorations failed. The three failed Class II SureFil restorations had a mean ± standard deviation cavity volume of 254 ± 45 cubic millimeters with a cavity depth of 5.7 ± 1.8 mm, while the intact Class II restorations had a much smaller mean volume of 76 ± 23 mm3 with a depth of 4.0 ± 0.3 mm. By comparison, for SpectrumTPH, the intact Class II restorations had a mean cavity volume of 30 ± 7 mm 3 with a depth of 3.6 ± 0.3 mm.

Rating of the restoration parameters and factors. The assessors recorded only Alfa and Bravo ratings for the baseline and 12-month evaluations of the restoration parameters or factors (Figures 1Go and 2Go). They gave no Charlie or unsatisfactory ratings (Table 3Go, page 1586).



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  		Figure 1. SureFil (Dentsply DeTrey GmbH, Konstanz, Germany) distoocclusal restoration in first premolar rated Alfa for color match and Bravo for marginal integrity and marginal discoloration at 12 months (using the United States Public Health Service-Ryge modified criteria21).

 


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  		Figure 2. SureFil (Dentsply DeTrey GmbH, Konstanz, Germany) distoocclusal restoration in first molar rated Alfa for marginal discoloration and Bravo for marginal integrity and color match at 12 months (using the United States Public Health Service-Ryge modified criteria21).

 

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  		TABLE 3 EVALUATION RESULTS FOR SUREFIL* AND SPECTRUM TPH* RESTORATIONS.

 
Color match. Initially, the assessors gave Alfa ratings to 97 percent of the SureFil and 92 percent of the SpectrumTPH restorations. At the 12-month review, the Alfa ratings had decreased to 78 percent for the SureFil and 85 percent for the SpectrumTPH restorations. The assessors rated the color match for the other restorations as Bravo.

Marginal discoloration. None of the restorations showed marginal discoloration at baseline. At the 12-month review, 91 percent of the SureFil and 90 percent of the SpectrumTPH restorations received Alfa ratings. Any staining present was minor and confined to short sections of the margins of the affected restorations. It was more readily detected from the color photographs.

Marginal integrity. Many restorations had small marginal defects at the 12-month evaluation. The defects were related to minor deficiencies or fractured excesses of material, which may have been attributable partly to the finishing technique used during placement of the restorations. Alfa ratings had decreased at 12 months to 56 percent for the SureFil and 75 percent for the SpectrumTPH restorations.

Anatomical form/occlusal wear. Only slight wear changes were detected by direct clinical examination at the 12-month review. Alfa ratings were 93 percent for the SureFil and 97 percent for the SpectrumTPH restorations. However, the net mean (SD) occlusal wear as measured from the stone replicas was 38.2 (10.1) micrometers for the SureFil and 24.9 (9.9) µm for the SpectrumTPH restorations, without statistical significance (t = 0.877, df = 25, P = .39). The mean ± SD occlusal surface area was 16.5 ± 4.1 square millimeters for the SureFil and 12.7 ± 2.9 mm2 for the SpectrumTPH restorations, without statistical significance (t = 0.662, df = 25, P = .51). This is equivalent to an occlusal wear rate of 2.3 µm/mm2 and 2.0 µm/mm2, respectively. The assessors noted no open proximal contact gaps from the stone replicas for either material.

Surface texture and staining. Initially, almost all of the restorations exhibited a smooth surface comparable to the adjacent enamel. At the 12-month review, Alfa ratings were 93 percent for the SureFil and 97 percent for the SpectrumTPH restorations. No restoration had observable surface staining.

Expansion. For both materials, we detected no expansion of the restorations from baseline clinically or on the stone replicas at 12 months.

Gingival bleeding. At the baseline evaluation, the assessors rated almost all of the gingival tissues adjacent to the Class II restorations as being healthy. However, at the 12-month evaluation, Alfa ratings for the absence of gingival bleeding to blunt probing had decreased to 57 percent for the SureFil and 91 percent for the SpectrumTPH restorations. The mean ± SD widths of the Class II cavity preparations, which probably reflected the widths of the proximal boxes, were 3.6 ± 0.3 mm for SureFil and 2.7 ± 0.2 mm for SpectrumTPH, which was of borderline significance (t = 1.882, df = 28, P = .06). Larger proximal restoration surfaces may offer larger areas for plaque retention and, consequently, increased gingivitis.

Postoperative sensitivity. Initially, subjects reported tooth sensitivity for 7 percent of the SureFil and 3 percent of the SpectrumTPH restorations. At the 12-month evaluation, subjects reported some sensitivity for 9 percent of the SureFil and 3 percent of the SpectrumTPH restorations. The sensitivity was mild and only occasional in response to temperature changes. In two of the sensitive teeth restored with SureFil, the cavities were 6.0 mm and 6.5 mm deep. The mean ± SD depth of all the other cavities in affected teeth was 3.6 ± 0.7 mm.

At 12 months, there were no statistically significant differences between the clinical performances of the two restorative materials for any of the parameters evaluated. Therefore, the null hypothesis was accepted.


   DISCUSSION
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
CONCLUSION
 REFERENCES
 
The two resin-based composite restorative materials evaluated in this study were used in combination with a simplified bonding system. Pre-treatment of the cavity with NRC, which does not require rinsing after its application, followed by PBNT self-priming bonding resin, simplified the treatment procedure. While such a system is convenient to use, its effectiveness with packable composites has yet to be established.

The marketing of packable or high-density composites as amalgam substitutes has included the advertising of similar handling properties and occlusal wear, the ability to displace nonsectional matrix bands for achieving tight proximal contacts, fast bulk placement and deep light-curing of the composites. However, several packable composites have given unsatisfactory short-term clinical performances.24 Several of the materials also have performed more poorly than expected in terms of packability, polymerization shrinkage, depth of light curing and displacement of matrix bands, together with greater-than-expected microleakage at margins placed in dentin.3,11,25,26 In addition, their range of shades is limited, they cannot be carved and their surfaces may be less smooth and may wear more than those of minifilled conventional hybrid composites.6,27

The failed SureFil restorations all were placed in large, deep molar cavity preparations, and the vital pulps of several teeth apparently had been compromised before their restoration. With hindsight, it may have been inappropriate to restore such teeth with a resin-based composite material, although the packable composites are being marketed extensively as amalgam substitutes, and although we first placed a glass ionomer cement as a base.

Retention. According to a recent laboratory study, the use of NRC with PBNT produced a thinner hybrid layer and shorter resin tags in dentin than was found with phosphoric acid–conditioned dentin and PBNT.16 However, the NCR-PBNT combination has shown satisfactory in vitro enamel and dentin bond strengths,17,19,28 although the highest bond strengths to enamel were achieved with a combination of phosphoric acid etch and PBNT.17,29

Although we used a simplified cavity-conditioning method in this study—instead of either a separate phosphoric acid etching of enamel only, or the total-etch technique—the bonding of the two restorative materials was sufficient to provide adequate retention over 12 months.

Color match/surface texture and staining/gingival bleeding. Incorrect shade selection, together with a restrictive range of lighter shades for SureFil (A, B and C only), may have accounted for some initial mismatches. The dentists involved in the study selected six shades of SpectrumTPH. One other study reported some concerns after 12 months with the color matching and surface texture of SpectrumTPH, but not with SureFil.30 Another small study noted some instances of surface staining for SureFil after 12 months in subjects who smoked,31 and further instances of surface staining were apparent after two years.32 We observed no surface staining in our study. Both restorative materials exhibited relatively smooth surfaces after polishing, in comparison with the adjacent enamel surfaces. Therefore, the increased gingivitis observed with the Class II SureFil restorations may have been related to their larger sizes and, consequently, greater areas of plaque-retentive proximal surfaces.

In our study, marginal defects were often observed for both materials, but marginal discoloration was minimal and infrequent.

Marginal discoloration and integrity. Marginal discoloration usually results from defects present between the tooth-colored restoration and the cavity margins and walls. Defects may be caused by inadequate restoration placement and finishing procedures, by unsatisfactory bonding and by subsequent stress fatigue. Resin-based composites shrink on polymerization and can generate high stresses at bonded surfaces in confined cavity preparations.33 According to the manufacturer, the volumetric shrinkage for SureFil is 2.2 percent and that for SpectrumTPH is 2.5 percent.13,14 However, one study suggested that packable composites are less capable of reducing contraction stress during the early setting stage than is a conventional hybrid resin composite.34 In another study, the use of a syringeable composite resulted in significantly better restoration adaptation and fewer voids than did a packable composite.35 Unsatisfactory cavity sealing at the restoration-tooth interface can result in microleakage and, therefore, many researchers have recommended the use of flow-able liners with the high-viscosity packable composites to reduce microleakage at dentinal margins.36–39

In our study, marginal defects were often observed for both materials, but marginal discoloration was minimal and infrequent. Many of the minor defects appeared to result from the fracture of thin flashes of composite material extended onto noninstrumented enamel surfaces adjacent to the cavity margins. The use of phosphoric acid etching may reduce the occurrence of such defects, especially in high-stress–bearing regions, because of the improved enamel etching.16 One 12-month study, which used a total-etch technique with Prime & Bond 2.1 (Dentsply Caulk), reported 100 percent Alfa ratings for the marginal integrity of Class II SureFil restorations.31 The ratings remained unchanged after two years.32

Anatomical form and occlusal wear. SureFil has been advertised by the manufacturer to offer "everything you demand of an amalgam" and to "deliver amalgamlike wear rates." However, such claims have not been substantiated by independent research,40 and amalgam has shown lower in vitro wear rates.41 One study concluded that "these new packable composites would not offer improved clinical performance over current non-packable composites in terms of wear resistance."4

After one and two years, another clinical study of SureFil found mean occlusal wear rates of 2.3 µm and 13.8 µm, respectively.31,32 In our 12-month study, using the same semiquantitative Vivadent wear scale, SureFil’s mean occlusal wear was higher (38.2 µm), but the wear for SpectrumTPH (24.9 µm) approximated that for another earlier composite (Prisma TPH, Dentsply Caulk) (23.6 µm) in a similar study involving primary molars.42 In these latter two studies, the cavosurface margin showing the most severe wear determined the rating given for each restoration. A different rating method, which averaged the score for each restoration, was used in the former study.31,32 The semiquantitative Vivadent wear scale has been shown to achieve a higher level of agreement regarding restoration wear and more uniform scores among different evaluators than have other comparable methods.43 The stone replicas showed good proximal contacts for both resin-based composites, without any obviously superior results for high-viscosity materials such as SureFil.3,44

Postoperative sensitivity. Anecdotal and some limited clinical trial evidence suggests that postoperative sensitivity is reduced considerably when using self-etching bonding systems.15,45 In our study, although several restored teeth with initially deep carious lesions continued to show some occasional mild sensitivity after 12 months, the overall findings support the effectiveness of the NRC/PBNT bonding system.


   CONCLUSION
TOP
 ABSTRACT
 SUBJECTS, MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
REFERENCES
 
Our initial 12-month findings showed that the clinical performances of a packable resin-based composite, SureFil, and a conventional hybrid resin-based composite, SpectrumTPH, when used with a simplified bonding system, were satisfactory and not significantly different. Longer-term observations are required to monitor the performances of the two posterior composite materials and the bonding system used.


   FOOTNOTES
 

Dr. Yip is an associate professor in oral diagnosis, Faculty of Dentistry, The University of Hong Kong, The Prince Philip Dental Hospital, 34 Hospital Road, Hong Kong SAR, PR China, e-mail "Kevin.H.K. Yip{at}hkusua.hku.hk". Address reprint requests to Dr. Yip.


Dr. Belinda Poon is an honorary assistant professor in conservative dentistry, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, PR China.


Dr. Chu is an assistant professor in oral diagnosis, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, PR China.


At the time this article was written, Dr. Eric Poon was a dental student, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, PR China. He is now working as a general dental practitioner, Howloon, Hong Kong SAR, PR China.


At the time this article was written, Dr. Kong was a dental student, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, PR China. She is now working as a general dental practitioner, Howloon, Hong Kong SAR, PR China.


Dr. Smales is a visiting research fellow, Dental School, The University of Adelaide, Adelaide, South Australia.


The authors gratefully acknowledge financial assistance from the Committee of Research and Conference Grants, The University of Hong Kong (grant 10202573). This clinical trial was conducted independently and supported completely by university grants.


The authors gratefully acknowledge the assistance of Emeritus Professor S.H.Y. Wei and Dr. Philip Newsome, Faculty of Dentistry, The University of Hong Kong, for the idea and support for the original research project and for their assistance with it.


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

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