JADA Continuing Education
Two-year clinical evaluation of a packable resin-based composite
L. 
EBNEM TÜRKÜN, D.D.S., Ph.D.,
MURAT TÜRKÜN, D.D.S., Ph.D. and
FERIT ÖZATA, D.D.S., Ph.D.
 |
ABSTRACT
|
|---|
Background. Packable resin-based composites were introduced in 1998, but few clinical studies have been conducted to evaluate them. The authors conducted a clinical study to determine the two-year performance of SureFil (Dentsply DeTrey GmbH, Konstanz, Germany) packable posterior resin-based composite in Class I and II restorations.
Methods. An operator (L..T.) restored 55 cavities in 36 patients (16 Class I restorations and 39 Class II restorations). After cavity preparation, she etched the enamel with 34 percent phosphoric acid, applied Prime & Bond NT (Dentsply DeTrey GmbH) to dentin and etched enamel for 20 seconds and then cured it for 20 seconds. She restored the cavity using 3-to 5-millimeter increments of SureFil. Independent examiners assessed the restorations after placement and at six months, one year and two years for color matching, marginal discoloration, marginal adaptation, secondary caries, surface texture, anatomical form and postoperative sensitivity, using the Ryge criteria.
Results. The authors assessed the changes in the parameters during the two-year period using a software program with Friedman test analysis with a Bonferroni adjustment at significant level of P = .05. At baseline, 31 restorations were graded as Bravo for color match. At the six-month and one-year recall periods (n = 55), 53 restorations remained unchanged. Two restorations from the same patient fell out after one month. After two years (n = 50), there were five Bravos for surface staining and three for marginal adaptation (P < .05).
Conclusion. After two years of clinical service, SureFil packable resin-based composite had a success rate of 96 percent, and the authors considered it successful in Class I and II restorations.
Clinical Implications. SureFil packable resin-based composite can be successful in clinical situations with limited-sized cavities and proper application of restorative techniques.
Recent advances in resin-based adhesives and restorative materials, as well as increased patient demand for esthetic restorations, have stimulated an increase in the use of resin- based composites in posterior teeth.1 Many clinicians have been using posterior resin-based five to 10 years.2 At the time of their introduction three decades ago, however, the performance of these materials was poor due to inadequate wear resistance, leakage, secondary caries and lack of appropriate proximal contact.3 Today, the cause of these problems has been identified and, to a great extent, resolved.
Choosing limited-sized cavities and paying meticulous attention to the restorative technique are essential for achieving longer-term clinical success with posterior resin-based composite restorations.
The technique for placing these resin-based composites is focused mainly on reducing polymerization shrinkage by adding material incrementally and curing successive layers of composite one at a time. When this material is placed in bulk, it shrinks away from the cavosurface marginal areas, leading to potential bacterial infiltration and recurrent caries. Furthermore, when these materials are pushed with a condensing instrument, there is no resistance to the force placed on the material; the material does not move the composite in the direction of the force but merely pushes through it.4
It is more difficult to obtain proper contour and achieve adequate proximal contact in larger Class II cavity preparations with conventional resin-based composites than it is with amalgam, because conventional resin-based composites are not packable.5 To improve ease of manipulation, the ideal resin-based composite should have a viscosity stiff enough to facilitate placement without adhering to the condensing instrument.6
Since 1998, highly viscous, packable resin-based composites have been available to dental practitioners.
There is a belief among dentists that posterior resin-based composites should be condensed or packed into the preparation to get a good adaptation, and, therefore, "condensable" or "packable" resin-based composites would be required by the profession.7 As a result, since 1998, highly viscous, packable resin-based composites have been available to dental practitioners. They are characterized by a stiffer and less sticky consistency that allows them to be packed more easily than hybrid composites. According to the manufacturers, they are good for stress-bearing posterior restorations and have improved handling properties.1,8,9 The new packable resin-based composite stays in place, regardless of the time required for sculpting before light-curing.1 The material is less technique-sensitive and can be inserted and condensed using procedures familiar to clinicians. Slight modifications in procedural techniques allow clinicians to complete resin-based composite restorations in less time than in the past. The manufacturers marketed packable resin-based composites as having annual wear rates equal or superior to those of amalgam, low polymerization shrinkage, close coefficient of thermal expansion to the tooth and similar modulus of elasticity to amalgam.8,9 Although early laboratory studies of packable resin-based composites support these claims, recently performed in vitro investigations demonstrated that their physical properties do not differ from the hybrid resin-based composites.1,10,11
The claims that packable resin-based composites solve many of the clinical problems associated with current resin-based composites used in posterior restorations are attractive. Controlled independently performed clinical studies are the only basis for manufacturers making dependable clinical claims. However, clinical studies to test these properties with packable resin-based composites have not been longitudinal12–15 because the material was introduced to the market in 1998. Therefore, we conducted this study to determine the two-year performance of SureFil (Dentsply DeTrey GmbH, Konstanz, Germany) packable resin-based composite in Class I and II restorations.
|
MATERIALS AND METHODS
|
|---|
We included in this study 36 patients (22 women and 14 men) who came to the Department of Restorative Dentistry, School of Dentistry, Ege University, Izmir, Turkey, and who demonstrated good oral hygiene. We obtained the subjects’ written consent at the start of the project, and the study protocol was approved by Ege University’s human ethical research committee. We placed 55 restorations (approximately one to two restorations per subject) in 34 molars and 21 premolars. Seventy-one percent of the cavities (39) were Class II restorations and 29 percent (16) were Class I restorations. We used the packable resin-based composite SureFil to restore the teeth. The properties of this material are shown in Table 1
.
An operator (L..T) recorded the teeth’s vitality test scores and then prepared, restored and finished 55 cavities, following standard procedures and the manufacturer’s directions. She performed adhesive cavity design with no beveling for previously unrestored teeth, as well as for restored teeth that required modifications of the cavity. The cavosurface margins of all restorations terminated on the enamel. Forty-nine restorations were small to moderate, and six were large. The small-to-moderate restorations extended between one-quarter and one-third of the way up one or more of the cuspal slopes. The proximal portion of the Class II caries extended into the interproximal embrasures, but the margins did not end above the cementoenamel junction. The operator prewedged the proximal area of the carious teeth with an anatomically contoured interdental wedge before Class II cavity preparation.
Evaluation parameters included color-matching ability, marginal adaptation, anatomical form, cavosurface marginal discoloration, secondary caries, surface texture and postoperative sensitivity.
After the preparation was completed, the operator placed a hard-setting calcium hydroxide cement over the deepest dentin part of the cavity to protect the pulpal tissues. She then etched the cavosurface margins of the enamel for 15 seconds and the dentin for 20 seconds with 34 percent phosphoric acid gel, washed them for 15 seconds and dried them with oil-free air. She immediately applied a thin layer of bonding resin (Prime & Bond NT, Dentsply DeTrey GmbH) over the entire surface of the acid-etched preparation for 20 seconds, dried it gently and light-cured it for 20 seconds. The light from the light-activating unit was tested before each placement to ensure an output in excess of 400 watts per square millimeter. Before restoring the Class II caries, a thin stainless steel matrix band held in a Tofflemire retainer was adapted and firmly wedged in the proximal area to closely adapt the matrix to the gingival margin of the preparation and to achieve a degree of tooth separation to facilitate the restoration of the contact area.
The operator placed the restorations in bulk of 5 mm in the proximal box of Class II preparations, per the manufacturer’s recommendations, and in 3-mm increments on the other sides of the cavities; each increment was cured for 40 seconds. Contouring and finishing of the restorations were completed using water-cooled microfine diamond finishing burs followed by abrasive aluminum oxide disks. The operator used articulating paper to establish appropriate occlusal morphology and contacts.
|
CLINICAL EVALUATION
|
|---|
The restorations were rated by independent examiners with mirrors and probes using the method developed by Ryge, which also is known as the U.S. Public Health Service criteria.16 Evaluation parameters included color-matching ability, marginal adaptation, anatomical form, cavo-surface marginal discoloration, secondary caries, surface texture and postoperative sensitivity. For each of the criteria, we used a score of Alfa to indicate the highest degree of clinical acceptability, and we used scores of Bravo, Charlie and Delta to indicate progressively lessening degrees of clinical acceptability (Table 2).
Each restoration was evaluated by two clinicians who did not perform the clinical procedures and who were calibrated before the study by a joint examination of 20 resin-based composite restorations each. When there was disagreement during an evaluation, the two clinicians made the decision by consensus. They assessed the restorations at baseline, six months, one year and two years. Periapical radiographs for secondary caries detection were taken, vitality tests were recorded and color photographs were taken at every recall period for two years.
We regarded all restorations scored as Charlie or Delta or those that had been replaced at the two-year recall period as having failed. The changes in the parameters during the two-year period were assessed using a statistical software program with Friedman test analysis, which is the nonparametric analysis of variance. We compared the baseline scores with those at the recall periods using Wilcoxon signed rank test with Bonferroni adjustment. We tested the influence of the teeth and restoration type on the restoration performance with Fisher exact test. The significant level was set at P = .05.
|
RESULTS
|
|---|
At the two-year follow-up examination, we examined 50 of the 55 restorations (91 percent) (Table 3). The five missing restorations preliminarily were due to patient dropout, and two restorations in the same patient had to be replaced after one month due to his occlusion. These two failed restorations were included in the number of the 50 rated restorations.
The vitality of the restored teeth did not change during the two-year period. None of the patients complained about postoperative sensitivity at any time during the study. There was no evidence of secondary caries in any of the restorations according to the bitewing radiographs that were taken. After the two-year recall period, we classified surface texture as Alfa for all restorations (P > .05). Figures 1 and 2 (page 1210) showed restorations classified as Alfa after the two-year period. Relative to marginal adaptation, three restorations showed evidence of a slight crevice along the marginal interface (Figure 3, page 1210) after two years (P < .05). One restoration had marginal discoloration at the one-year recall period (Figure 4, page 1210) and four others had marginal discoloration at the two-year recall period (P < .05). Two restorations had been graded Bravo for anatomical form since the one-year recall period (P > .05). The color match of 31 restorations (n = 55) was scored as Bravo at the baseline examinations. This criterion had not changed during the two-year period (Figure 4, page 1210).
View larger version (104K):
[in this window]
[in a new window]
|
Figure 1. A Class II mesio-occlusal restoration using the resin-based composite in the maxillary left first molar (arrow) at the two-year recall period clinically rated as Alfa.
| |
View larger version (112K):
[in this window]
[in a new window]
|
Figure 2. An excellent mesio-occlusal restoration in the maxillary right first molar (arrow) after two years.
| |
View larger version (112K):
[in this window]
[in a new window]
|
Figure 3. A crevice (arrows) along the margin of the disto-occlusal Class II restoration in the maxillary right first molar after two years.
| |
View larger version (112K):
[in this window]
[in a new window]
|
Figure 4. Two Class I restorations in the mandibular right molars (arrows). The restoration on the first molar was excellent, while the restoration of the second molar had color-mismatch and marginal discolorations after two-year period.
| |
We found no statistically significant difference between Class I and Class II restorations (P > .05). Similar results were obtained when we compared the findings of pre-molar and molar restorations (P > .05).
|
DISCUSSION
|
|---|
The color match, surface texture and absence of secondary caries remained unchanged during the two-year period for SureFil packable resin-based composite restorations. At the two-year recall period, there were five Bravos for surface staining and three Bravos for marginal adaptation. These score changes were statistically significant; however, as restorations scored as Bravo are not considered to be clinically unacceptable, we concluded that the SureFil packable resin-based composite did fulfill the ADA acceptance criteria for restorative materials, which is 95 percent acceptable restorations rates at the two-year recall period.17
Two adjacent restorations fell out, and the operator replaced them with amalgam after one month. Owing to the patient’s occlusion, the amalgam restorations fell out one week later. The depth and the design of the cavity had to be modified, and we considered the two restorations to have failed.
Within the same period, 10 percent of the restorations showed a slight color change at the restoration margins. Despite the early identification and overall high levels for this criterion, discoloration was not found to be associated with or to necessarily lead to recurrent caries being diagnosed clinically.
At the end of the study, 6 percent of the restorations had a slight crevice along the marginal interface. The crevices probably were the result of a fracture of overlapping fine-type marginal excess, which formed a ledge that caught the explorer during the follow-up examination. We found that 2 percent of the restorations evaluated were undercountoured approximal contours.
The color match of 31 restorations was scored as Bravo at the baseline examination; this remained the same throughout the two-year period. This was due to the limited choice of color shades (only three) for SureFil. The restorations were predominantly lighter than the adjacent tooth structure. According to the manufacturer, the shades were deliberately selected to be lighter than the corresponding Vita (Vita Zahnfabrik H. Rauter GmbH KG, Bad Säckingen, Germany) shades so that marginal areas could be visualized during placement. We, however, think that patients’ demand for posterior resin-based composites is due mostly to their esthetic properties. Therefore, a posterior resin-based composite should have enough shades available to match the color of the adjacent teeth.
In an attempt to overcome some of the difficulties associated with the placement of posterior resin-based composite restorations, manufacturers developed "condensable" or "packable" resin-based composites. These resin-based composites are filled with glass to increase viscosity and condensability. These materials do not feel like amalgam when they are condensed, but they can deform a matrix band when they are inserted with an instrument, and they allow a tight proximal contact.1,10,18–20 These materials have 60 to 70 percent filler volume. The range of particle sizes in many of these materials is greater than that for "conventional" hybrid resin-based composites, whose filler sizes are 0.04 to 10 micrometers.8
SureFil achieves its packability by using a wide range of irregularly shaped and different-sized filler particles that the manufacturers say produce an "interlocking" effect between the larger and smaller particles.9 According to Combe and Burke,21 this may be achieved because of the large variation in particle sizes (0.04–10 µm), with the larger particles preventing the flow of smaller particles past or around the larger 10-µm particles. This coupling of filler and resin technologies gives SureFil the posterior resin-based composite attributes of packability, carvability, nonslumping and polishability.
In a two-year clinical trial, Perry and Kugel12 evaluated the performance of SureFil. At the one-year recall period, three restorations were scored Bravo for surface staining, and three more were scored Bravo at the two-year recall period. There was no evidence of secondary caries. The investigators concluded that this high-density resin-based composite material demonstrated clinical acceptability.
Loguerico and colleagues13 evaluated the one-year clinical performance of four packable resin-based composite restorative materials compared with one hybrid resin-based composite. They found that Solitaire (Heraeus Kulzer GmbH, Wehrheim, Germany) and TPH (Dentsply DeTrey GmbH) showed some fractures at the marginal ridges. Moreover, Solitaire, Alert (Jeneric Pentron, Wallingford, Conn.) and TPH had some concerns related to color match and surface texture, while SureFil and Filtek P60 (3M ESPE, St. Paul, Minn.) had excellent clinical performance. Our findings are in agreement with those of Perry and Kugel12 and Loguerico and colleagues.13
Ernst and colleagues14 evaluated the clinical performance of the packable resin-based composite Solitaire over three years. At the end of the study, 18.2 percent of the restorations were scored Bravo for marginal adaptation, 15.2 percent for anatomical form, 26.1 percent for marginal discoloration and 3.5 percent for secondary caries. After three years, 79 percent of the restorations still were performing at clinically acceptable levels. Therefore, Solitaire failed to meet the ADA’s criteria for resin restoratives.17
Oberlander and colleagues15 investigated the clinical performance of the packable resin-based composites Definite (Degussa Dental GmbH, Hanau, Germany) and Solitaire at one year. At the end of the study, Definite showed significantly worse marginal adaptation compared with Solitaire. Furthermore, both materials displayed significant discoloration and deterioration of approximal contact and restoration fracture. With a failure rate of 9.6 percent after one year, Definite did not fulfill the ADA’s criteria for restorative materials.17
The longevity of restorations is dependent on many factors, including operator skill, the materials and techniques used, the replacement criteria, patients’ compliance with oral hygiene advice, the oral environment and its contribution to the patients’ susceptibility to caries, and possibly the means by which the treatment is funded.22 There are no shortcuts to use when placing posterior resin-based composites, and any compromise in the placement technique will have serious consequences for the clinical performance. Dentists should realize that placing a posterior resin-based composite could take approximately two and one-half times as long as placing a similar amalgam restoration.23,24
Choosing limited-sized cavities and paying meticulous attention to the restorative technique are essential for achieving longer-term clinical success with posterior resin-based composite restorations. Evaluations, however, still need to be conducted to reveal the longer-term clinical performance of packable resin-based composites.
|
CONCLUSION
|
|---|
After two years of clinical service, SureFil packable resin-based composite had a success rate of 96 percent, and we considered it to be successful in restoring Class I and II restorations.
View larger version (51K):
[in this window]
[in a new window]
|
Dr. L. ebnem Türkün is an assistant professor, Department of Restorative Dentistry and Endodontics, Ege University, School of Dentistry, 35100 Izmir, Turkey, e-mail "sebnemturkun{at}hotmail.com". Address reprint requests to Dr. Türkün.
| |
View larger version (43K):
[in this window]
[in a new window]
|
Dr. Murat Türkün is an associate professor, Department of Restorative Dentistry and Endodontics, Ege University, School of Dentistry, Izmir, Turkey.
| |
View larger version (39K):
[in this window]
[in a new window]
|
Dr. Özata is a professor and the head, Department of Restorative Dentistry and Endodontics, Ege University, School of Dentistry, Izmir, Turkey.
| |
|
FOOTNOTES
|
|---|
The authors would like to thank Timur Köse, Ph.D., for the statistical analysis and Atlan Destici for his help on the photographs.
|
REFERENCES
|
|---|
- Cobb DS, MacGregor KM, Vargas MA, Denehy GE. The physical properties of packable and conventional posterior resin-based composites: a comparison. JADA 2000;131:1610–5.
- Gerbo L, Leinfelder KF, Mueninghoff L, Russell C. Use of optical standards for determining wear of posterior composite resins. J Esthet Dent 1990;2(5):148–52.[Medline]
- Leinfelder KF. Posterior composite resins: the materials and their clinical performance. JADA 1995;126:663–72.
- Nash RW, Lowe RA, Leinfelder KF. Using packable composites for direct posterior placement. JADA 2001;132:1099–4.
- Miller MB, Castellanos IR, Vargas MA, Denehy GE. Effect of restorative materials on microleakage of Class II composites. J Esthet Dent 1996;8(3)107–13.[Medline]
- Opdam N, Roeters J, Peter TC, Burgersdijk R, Kuijs R. Consistency of resin composites for posterior use. Dent Mater 1996;12:350–4.[Medline]
- Wilder AD Jr., Bayne SC, Heymann HO. Long-term clinical performance of direct posterior composites. Trans Acad Dent Mater 1996;9:151–9.
- Condensable restorative resins. CRA Newsletter 1998;22(7):1.
- SureFil (product profile). Weybridge, England: Dentsply UK; 1998.
- Choi KK, Ferracane JL, Hilton TJ, Charlton D. Properties of packable composites. J Esthet Dent 2000;12:216–26.[Medline]
- Brackett WW, Covey DA. Resistance to condensation of ‘condensable’ resin composites as evaluated by a mechanical test. Oper Dent 2000;25:424–6.[Medline]
- Perry RD, Kugel G. Two-year clinical evaluation of a high-density posterior restorative material. Compend Contin Educ Dent 2000; 21(12):1067–76.
- Loguercio AD, Reis A, Rodrigues FL, Busato AL. One-year clinical evaluation of posterior packable resin composite restorations. Oper Dent 2001;26(5):427–34.[Medline]
- Ernst CP, Martin M, Stuff S, Willershausen B. Clinical performance of a packable resin composite for posterior teeth after three years. Clin Oral Investig 2001;5(3):148–55.[Medline]
- Oberlander H, Hiller KA, Thonemann B, Schmalz G. Clinical evaluation of packable composite resins in Class II restorations. Clin Oral Investig 2001;5(2):102–7.[Medline]
- Ryge G, Snyder M. Evaluating the clinical quality of restorations. JADA 1973;87:369–77.
- ADA Council on Scientific Affairs; ADA Council on Dental Benefit Programs. Statement on posterior composites. JADA 1998;129:1627–8.
- Sakaguchi RL, Douglas WH, Peters MC. Curing light performance and polymerization of composite restorative materials. J Dent 1992;20(3):183–8.[Medline]
- Nash RW, Radz GM. Condensable composites. J Am Acad Cosmet Dent 1998;46–0.
- Freedman G. Condensable composites: the new paradigm in amalgam alternatives. Dent Today 1998;17(10):72–4.
- Combe EC, Burke FJ. Contemporary resin-based composite materials for direct placement restorations: packables, flowables and others. Dent Update 2000;27:326–36.[Medline]
- Burke FJT, Wilson NHF, Cheung SW, Mjör IA. Influence of patient factors on age of restorations at failure and reasons for their placement and replacement. J Dent 2001;29:317–24.[Medline]
- Leidal TI. Accomplishments and expectation with posterior composite resins. In: Vanherle G, Smith DS, eds. Posterior composite resin dental restorative materials. St. Paul, Minn.: 3M Espe; 1985:541–7.
- Mjör IA. Long term cost of restorative therapy using different materials. Scand J Dent Res 1992;100:60–5.[Medline]
TOP
ABSTRACT
MATERIALS AND METHODS
