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J Am Dent Assoc, Vol 140, No 1, 28-37.
© 2009 American Dental Association | ![]() |
COVER STORY |
| ABSTRACT |
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Methods. The authors placed a total of 99 Class V restorations using either a filled, ethanol-based adhesive (OptiBond Solo [OS], SDS Kerr, Orange, Calif.) or an unfilled, acetone-based adhesive (Prime & Bond 2.1 [PB] Dentsply Caulk, Milford, Del.) and a hybrid resin-based composite in 33 subjects with noncarious cervical lesions. The authors did not bevel the enamel margins and used no mechanical retention. They evaluated the restorations at baseline and for as long as eight years after placement using modified U.S. Public Health Service criteria. They analyzed differences between groups using appropriate statistical tests.
Results. The authors examined 56 restorations after eight years and found retention rates of 69 percent for OS and 59 percent for PB. These rates did not differ statistically (P = .449) and were not significantly affected by subject or lesion characteristics. The authors noted marginal discoloration on 55 percent of the retained OS restorations and on 31 percent of the retained PB restorations, but they detected no secondary caries around any restoration. They noted poor anatomical form and poor marginal adaptation in 15 percent and 40 percent of the retained OS restorations, respectively.
Conclusions. The performance of both adhesives was good during this eight-year clinical trial. The filled, ethanol-based adhesive OS demonstrated slightly better bond durability than did the unfilled, acetone-based adhesive PB, but the difference between the two materials was not statistically significant.
Clinical Implications. Despite a high incidence of marginal discoloration, the one-bottle adhesives evaluated in this study provided good clinical retention of Class V restorations without mechanical retention. When the materials are used properly, restorations are retained at an acceptable rate through at least eight years of clinical service.
Key Words: Dental adhesives; dental materials; dentin-bonding agents; restorative dentistry: operative; resin-based composites; randomized controlled clinical trials
Abbreviations: A: Alfa B: Bravo BIS-GMA: Bisphenol A glycidyl dimethacrylate C: Charlie DEJ: Dentinoenamel junction IRB: Institutional review board LTF: Lost to follow up LVR: Low-viscosity resin NCCLs: Noncarious cervical lesions OS: Opti-Bond Solo PB: Prime & Bond UNC: University of North Carolina USPHS: US Public Health Service.
Enamel and dentin bonding has evolved from a multistep, relatively complex task to a much simplified application protocol. The first clinically successful bonding agents ("three-step etch-and-rinse adhesives") comprised separate conditioning, priming and bonding steps. Most modern adhesives combine these functions into either two steps ("two-step etch-and-rinse" or one-bottle adhesives, and "two-step self-etching primers") or a single step ("all-in-one" adhesives). Although many simplified adhesives perform adequately in laboratory studies when compared with their traditional multistep counterparts,1–3 clinical trials are necessary to verify laboratory results and assess their clinical performance.
A 2005 review of the clinical effectiveness of contemporary dental adhesives revealed that few studies report clinical performance of one-bottle adhesives for three years or more, with retention rates up to three years ranging from 50 percent to 100 percent.4 The average annual failure rate for one-bottle adhesives is approximately 6 percent, which is slightly higher than the reported 5 percent annual failure rate of three-step etch-and-rinse and two-step self-etch adhesives. The retention curves for one-bottle adhesives typically show a decline in the first three years of evaluation,4 but the lack of long-term studies prevents a better understanding of their long-term performance. To our knowledge, there are only three published clinical trials of one-bottle adhesives beyond three years, showing retention rates of 85 percent at four years and 55 percent and 100 percent at five years.5–7 Long-term clinical trials are needed as supporting evidence of the longevity of these adhesives.
Evidence from laboratory studies suggests that filled adhesives can provide stress relief that compensates for composite polymerization shrinkage and occlusal forces.8–13 In 1998, we initiated a clinical trial at the University of North Carolina (UNC) at Chapel Hill to compare the clinical performance of a filled and an unfilled one-bottle adhesive used on noncarious cervical lesions (NCCLs). NCCLs are a good model with which to test the clinical performance of dental adhesives, because they provide no inherent macromechanical retention, typically include both enamel and dentin margins and are relatively simple to restore, thus minimizing the effect of operator variability.14 Preliminary results of this trial in 2001 indicated that the performance of both adhesives was excellent at 18 months and three years.15,16 We have continued to collect data since then.
The purpose of the study we conducted and describe here, therefore, was to evaluate the eight-year clinical performance of a filled and an unfilled one-bottle adhesive when used in restorations of NCCLs without retention grooves or enamel bevels. We tested the hypothesis that the two adhesives would provide similar clinical performance over time. The adhesives we tested were OptiBond Solo (SDS Kerr, Orange, Calif.) and Prime & Bond 2.1 (Dentsply Caulk, Milford, Del.). OptiBond Solo is an ethanol-based adhesive that is filled with barium glass and silica (approximately 25 percent by weight). It also contains bisphenol A glycidyl dimethacrylate (BIS-GMA), glycerol phosphate dimethacrylate, hydroxyethyl methacrylate, and sodium hexafluorosilicate. Prime & Bond 2.1 is an unfilled acetone-based adhesive that contains urethane dimethacrylate, dipentaerythritol pentaacrylate phosphate, R5-62-1 resin, BIS-GMA, butylated hydroxytoluene, 4-ethyl dimethyl aminobenzoate, camphorquinone and cetylamine hydrofluoride.
We enrolled subjects who sought treatment for NCCLs that needed restorations with no undercuts. We made no attempt to determine the etiology of the lesions. In general, no more than 50 percent of the cavosurface margin involved enamel, and at least 75 percent of the surface area of the restoration was in contact with dentin. All restored teeth contacted the opposing teeth in a normal occlusal relationship and had normal periodontal health.
We used stratified randomization to assign restorations to subjects. For the first enrolled subject, we made the assignment of restorative system for the first restoration randomly. The subsequent subject then would receive as a first restoration the alternate restorative system. We assigned the consecutive restorations for each subject alternately. To minimize subject-related effects that might distort the outcome of the study, we did not allow more than three restorations per subject for each restorative system. Nearly all subjects received restorations of both types.
Baseline sample characterization.
To ensure equivalence in the sample between the restorative systems, we collected subject, tooth and lesion characteristics at baseline. We collected information regarding subjects age and sex on enrollment; determined the tooths occlusal status as traumatic or not (with traumatic occlusion defined by the presence of fremitus or wear facets); and determined the lesions location (maxillary or mandibular arch), tooth (anterior, premolar, molar), internal angle (in four categories: 0–45o, 45–90o, 90–135o, 135–180o), percentage of enamel margin (in three categories: 0–12 percent, 25–50 percent, 50–75 percent), dimensions (height, width and depth in millimeters) volume (in cubic millimeters) and score on the Dentin Sclerosis Scale17,18 (Table 1
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SUBJECTS, MATERIALS AND METHODS
TOP
ABSTRACT
SUBJECTS, MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
REFERENCES
Enrollment and sampling.
We enrolled 33 subjects ranging in age from 27 to 77 years (mean = 53 years) in the study, and we excluded subjects with fewer than 20 teeth. We identified subjects from the university community, dental clinics and advertisements approved by the UNC Institutional Review Board (IRB). To be included, subjects had to have a dental health status considered normal in all respects—that is, subjects had no oral conditions such as periodontal disease, occlusion-related problems, unusually high caries rates or other soft- or hard-tissue related problems. We did not exclude subjects on the basis of their general health or medical history; they were in overall good health. Before participating in the study, all subjects signed a consent form that had been reviewed and approved by the UNC IRB.
). We measured the aforementioned variables visually, with the aid of a periodontal probe where appropriate. We calculated lesion volume via extrapolation from the height, width and depth measurements.
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We applied the adhesive systems (OptiBond Solo or Prime & Bond 2.1) according to directions given by the manufacturers. For OptiBond Solo, we etched enamel and dentin for 15 seconds using 37.5 percent phosphoric acid, rinsed the tooth surface and lightly dried it with compressed air, avoiding desiccation. We applied OptiBond Solo with a light brushing motion for 15 seconds. In accordance with the manufacturers instructions, we did not dry the material with air but immediately light-activated it for 20 seconds. We applied a second coat and cured it in the same manner.
For Prime & Bond 2.1, we etched the enamel and dentin for 15 seconds with 34 percent phosphoric acid, rinsed the surface and blotted excess moisture with a moistened cotton pellet. We applied Prime & Bond 2.1 and replenished the solution as needed during a 20-second period. We gently air-dried the treated surface for five seconds. If the surface did not appear glossy, we applied more adhesive. We light-activated the material for 10 seconds. We applied a second coat but, following the manufacturers directions, did not light-activate it.
We restored all lesions with light-activated hybrid resin-based composite restorative materials (Prodigy, SDS Kerr, for OptiBond Solo; TPH Spectrum, Dentsply Caulk, for Prime & Bond 2.1). Prodigy contains BIS-GMA, triethylene glycol dimethacrylate, ethoxylated BIS-GMA and UV-9 resins and is 79 percent by weight (59 percent by volume) filled with barium, aluminium, zinc oxide and fumed silica particles. TPH Spectrum contains urethane-modified BIS-GMA resin and is 77.5 percent by weight (57.1 percent by volume) filled with barium aluminosilicate glass and fumed silica particles.
We inserted the composites in increments of 2 mm or smaller. We light-activated each increment for 40 seconds using a quartz-tungsten-halogen visible light-curing device (Optilux 401, Kerr Demetron, Danbury, Conn.) that had an output of > 500 milliwatts per square centimeter throughout the study. After curing, we finished the restorations using tapered and/or flame-shaped 12-fluted carbide finishing burs or microfine diamonds and polished the restorations with slow-speed polishing cups and points (Enhance, Dentsply Caulk).
Direct evaluation criteria and procedures.
All authors (A.V.R., E.J.S., H.O.H., J.R.S. and A.D.W.) and four other examiners participated in the evaluation process. We examined the restorations at baseline, six months, 18 months, 36 months and eight years (mean 96 months ± SD 4 weeks) after placement. We recorded data regarding the following characteristics using modified U.S. Public Health Service (USPHS)19 direct evaluation procedures (Table 2
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We recorded postoperative sensitivity as present (Charlie) or absent (Alfa) after subject inquiry or if the tooth was sensitive to a stream of compressed air 2 to 3 centimeters from the restoration for three seconds. In terms of retention, we recorded restorations as completely retained (Alfa) or partially (Bravo) or completely lost (Charlie).
We obtained intraoral photographs of the teeth and restorations before and immediately after insertion and at each follow-up appointment for evaluation by a second investigator. The clinical photographs were 35-mm color transparencies obtained at an original magnification of x 1.5. For the eight-year follow-up visit, we obtained digital images instead of film transparencies. Whenever the clinical evaluation and the evaluation based on the transparencies or images did not agree, we obtained forced consensus by meeting to view and evaluate the photographs as projected on a screen.
In addition to the absolute retention rate, we calculated cumulative retention failure rates for each follow-up time using the following equation:20
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where PF = Number of previous failures before the current follow-up; NF = Number of new failures during the current follow-up; and RR = Number of restorations examined at the current follow-up.
Statistical analyses. We designed this study as an equivalence trial—that is, we tested the hypothesis that both restorative systems (adhesive and composite) would demonstrate similar clinical performance across time. Therefore, we based the power calculation not on expected differences between restorative systems, but rather on differences in performance of the restorative system across time (baseline versus evaluation times). For an estimated 30 percent difference in clinically unacceptable scores between baseline and eight years, the sample size we used adequately powered the study at 85 percent.
At baseline, we compared data on subjects age, sex and occlusion, lesion characteristics and operator between the two restorative systems using two-sample t tests (continuous variables) and
2 (categorical variables), to determine if the two groups were equivalent. The lesion characteristics we evaluated were internal angle, percentage of enamel margin, sclerosis scale value, and lesion size (height, width and depth) and volume.
We compared modified USPHS direct evaluation criteria scores of restorations placed with OptiBond Solo or Prime & Bond 2.1 at eight years for statistically significant differences using the Fisher exact test (P = .05). We used lesions/restorations as the unit of analysis (cases). Although restorations placed in the same subject were not totally independent cases, the assignment of restorations to subjects was randomized. Therefore, subject and lesion characteristics were not expected to affect outcomes. However, to test for the influence of such characteristics on the performance of the restorative systems, we used logistic regression to control for factors such as operator; subjects age, sex and occlusion; and lesions location, size and score on the sclerosis scale.
Finally, we ran a survival analysis and derived a Kaplan-Meier survival estimate curve on the clinically unacceptable (Charlie) scores for any of the USPHS criteria at the different follow-up times. We used a log rank test for equality of survivor function to compare the survival estimates of the two restorative systems. We used Stata 10 data analysis and statistical software (StataCorp, College Station, Texas) for all statistical analyses.
| RESULTS |
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Tables 4
through 6![]()
present summaries of the clinical evaluations. We found no secondary caries or postoperative sensitivity in any of the evaluated teeth or restorations at eight years. We noted marginal discoloration around 55 percent of the retained OptiBond Solo restorations and 31 percent of the retained Prime & Bond 2.1 restorations, and poor marginal adaptation on 40 percent of the OptiBond Solo restorations. The unadjusted retention rates at eight years were 69 percent for OptiBond Solo and 59 percent for Prime & Bond 2.1. Using the American Dental Association Council on Dental Materials, Instruments, and Equipments revised Acceptance program guidelines for dentin and enamel adhesive materials19 formula, the cumulative eight-year retention rates were 65.6 percent for OptiBond Solo and 60.6 percent for Prime & Bond 2.1. None of the differences between the restorative systems was statistically significant for retention (P = .449), marginal discoloration (P = .293), anatomical form (P = .270) or marginal adaptation (P = .056).
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| DISCUSSION |
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At this eight-year follow-up, cumulative retention rates were 65.6 percent for OptiBond Solo and 60.6 percent for Prime & Bond 2.1. These rates are equivalent to approximately 70 percent and 68 percent of the retention rates of the respective restorative systems at the three-year follow-up (cumulative retention rates of 93.3 percent for OptiBond Solo and 89.4 percent for Prime & Bond 2.1 at the three-year evaluation). Most publications regarding similar one-bottle etch-and-rinse adhesives show retention rates ranging from 32 percent to 100 percent with observation times up to five years.5–7,21–28 It is not surprising that the retention rates we report here fall within the wide range of the rates in previously published data. Similar retention rates have been reported for clinical trials of three-step etch/prime/bond systems.24,28–35
At the three-year follow-up evaluation, both the OptiBond Solo/Prodigy and the Prime & Bond 2.1/TPH restorative systems performed very well, with retention rates and all other evaluation criteria rated "Alfa" for 88 to 100 percent of the examined restorations. The clinical performance for both systems appears to have deteriorated substantially between the three-year and eight-year evaluations. At eight years, of the retained OptiBond Solo/Prodigy restorations, 55 percent had interfacial staining (compared with 12 percent at three years); 40 percent had less than ideal marginal adaptation (compared with 5 percent at three years); and 15 percent had loss of anatomical form (compared with 2 percent at three years). Of the retained Prime & Bond/TPH restorations, 31 percent had interfacial staining (compared with 12 percent at three years) and 25 percent had a color mismatch (none had color mismatch at three years). ADA acceptance criteria call for less than 10 percent Charlie microleakage at 18 months.20 Although some authors define microleakage as being clinically undetectable,36 the ADA guidelines clearly reflect an interest in marginal integrity. In this study, we noted both marginal adaptation problems and interfacial staining in many of the retained restorations at eight years. We should note, however, that there were very few Charlie scores for the retained restorations, which may indicate that the noted marginal adaptation and staining problems might be related to clinically acceptable "aging" of the restorations.
In this study, we evaluated the clinical performance of both a filled (OptiBond Solo) and an unfilled (Prime & Bond 2.1) adhesive system. Filled adhesives or intermediate resins are designed to act as "elastic buffers" to relieve stresses within resin-based composite restorations caused by polymerization contraction, thermal changes and occlusal loading.8,9,13 Some systems that include a filled adhesive or a filled, intermediate low-viscosity resin (LVR) have been shown to significantly reduce marginal gaps and/or leakage around resin-based composite restorations in vitro.10,11,37–44
The resin-dentin interdiffusion zone, or hybrid layer, also has been shown to have a relatively low modulus of elasticity and also may relieve polymerization contraction stresses.13 One study showed that removal of surface collagen from demineralized dentin before primer application resulted in somewhat higher shear bond strengths, but also larger marginal gaps in complex restorations.45 However, removal of collagen prevented formation of this transition zone and resulted in wider marginal gaps, suggesting that the hybrid layer does function as a stress-absorbing layer between resin composite and dentin. The resin-dentin interdiffusion zone is not as thick as the adhesive layer (or combination of adhesive and LVR) that lies above it, so is expected to play a smaller role than does LVR in relieving stresses and maintaining marginal integrity.9
It is possible that filled adhesives provide a clinical benefit by acting as shock absorbers between relatively stiff resin composites and tooth substrates. For example, the original Opti-Bond maintains its marginal seal well when tested under simulated occlusal loading in vitro.37,40,41 In our study, the unfilled adhesive Prime & Bond 2.1 performed slightly (although not significantly) better than the filled adhesive OptiBond Solo at 18 months after placement. At three and eight years, however, the retention rates were reversed; that is, OptiBond Solo had a higher retention rate than Prime & Bond 2.1 (Tables 4
through 6![]()
). Although the difference between the two restorative systems was not statistically significant, this finding may indicate that the filled adhesive is more resistant to fatigue forces and could provide more durable retention than the unfilled adhesive. These clinical differences may be related to the adhesives module of elasticity (higher for OptiBond Solo than for Prime & Bond 2.1), although further research is needed to verify this hypothesis. The nonsignificant difference noted at three years did not change substantially at eight years, however.
We selected the restorative composites used in this study because they were recommended by the respective manufacturers of the dental adhesives tested. One well-controlled study noted no significant difference in adhesive performance when different composites were used (microfilled versus hybrid).46 Because the composition of the restorative composites used in this study are similar, we do not believe that the observed results are related to or influenced by them.
Finally, there has been some discussion about whether or not the roughening of the noncarious Class V lesions before placement of the adhesive restorations has any influence on their adhesion and, ultimately, their clinical performance.47 Although we did not intentionally place mechanical retentions or enamel bevels, roughening the exposed dentin and enamel may have increased the surface area available for bonding, hence improving the clinical performance of the restorations. However, little evidence exists comparing both techniques (roughening versus nonroughening). Two studies showed no difference in retention rates between Class V restorations placed in NCCLs with or without roughening.24,26
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| FOOTNOTES |
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