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J Am Dent Assoc, Vol 138, No 6, 763-772.
© 2007 American Dental Association | ![]() |
CLINICAL PRACTICE |
Findings From the New England Childrens Amalgam Trial
| ABSTRACT |
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Methods. The authors randomized children aged 6 to 10 years who had two or more posterior occlusal carious lesions into groups that received amalgam (n = 267) or compomer (primary teeth)/composite (permanent teeth) (n = 267) restorations and followed them up semiannually. They compared the longevity of restorations placed on all posterior surfaces using random effects survival analysis.
Results. The average ± standard deviation follow-up was 2.8 ± 1.4 years for primary tooth restorations and 3.4 ± 1.9 years for permanent tooth restorations. In primary teeth, the replacement rate was 5.8 percent of compomers versus 4.0 percent of amalgams (P = .10), with 3.0 percent versus 0.5 percent (P = .002), respectively, due to recurrent caries. In permanent teeth, the replacement rate was 14.9 percent of composites versus 10.8 percent of amalgams (P = .45), and the repair rate was 2.8 percent of composites versus 0.4 percent of amalgams (P = .02).
Conclusion. Although the overall difference in longevity was not statistically significant, compomer was replaced significantly more frequently owing to recurrent caries, and composite restorations required seven times as many repairs as did amalgam restorations.
Clinical Implications. Compomer/composite restorations on posterior tooth surfaces in children may require replacement or repair at higher rates than amalgam restorations, even within five years of placement.
Key Words: Dental amalgam; resin-based composites; compomers; dentition, primary; dentition, permanent; clinical trial; longevity
Abbreviations: NECAT: New England Childrens Amalgam Trial
Two randomized controlled clinical trials conducted in the United States and Portugal recently demonstrated the safety of dental amalgam restorations in children.1,2 Although these studies definitively addressed decades of controversy regarding the use of mercury-containing amalgam in children, dentists may continue to seek alternatives to amalgam that are thought to be more suitable for the restoration of posterior primary teeth or esthetically preferable for permanent teeth.
In the past three decades, resin-based composite restorative materials have become a common alternative to amalgam. The American Dental Association Council on Scientific Affairs concluded that both amalgam and resin-based compomer/composite materials are safe and effective for tooth restoration.3 However, controversy continues regarding which material is more durable.46
Amalgam and resin-based compomer/composite have vastly different physical and functional properties. Amalgam, which has been used in dentistry for more than 150 years, is a mixture of mercury and silver alloy powder that solidifies at mouth temperature. It is tolerant to a wide range of clinical placement conditions and moderately tolerant to the presence of moisture during placement. The biocompatibility and durability of amalgam are good-to-excellent in large load-bearing restorations, but the silver-colored material has little esthetic value, and controversy regarding its safety lingers.79
Adequate retention of amalgam in posterior primary teeth may be difficult given the tooth structure (thin enamel and dentin, shallow pits and fissures, narrow occlusal tables and enamel rods that run in the occlusal direction) compared with that of permanent teeth; thus, primary teeth in particular are thought to benefit from restoration with resin-based compomer, which may allow greater conservation of sound tooth structure than does amalgam.1015 Compomers, which were introduced into dentistry in the mid-1990s, are polyacid-modified resin-based composites that contain 72 percent (by weight) strontium fluorosilicate glass, with an average particle size of 2.5 micrometers.16 The presence of both acid functional monomer and basic ionomer-type glass attracts moisture into the material, which can trigger a reaction that releases fluoride and buffers acidic environments.17,18 In addition to its ability to release fluoride, compomer has the esthetic value of being tooth-colored and the practical value of having simple handling properties that are particularly useful in pediatric dentistry.16,19
For permanent teeth, dentists commonly use resin-based composites, a heterogeneous blend of organic resin and inorganic filler.20 For example, the hybrid composite consists of 60 to 65 percent volume filler of silica and glass and a particle size of 0.6 to 1.0 µm. The high percentage of filler particles provides strength, and the small size of the filler particles enhances polishability, which generally results in improved finishing qualities compared with compomer.21 In a 1991 report, Newman5 ranked composite as the superior restorative material in specific circumstances, such as those in enamel sites beyond the height of contour, in nonocclusal function, in cervical abrasion and in root caries. In 2002, Fuks7 recommended composite for small occlusal restorations, because composite placement requires less removal of sound tooth structure than does amalgam (though refurbishing is recommended22). Some researchers have cited marginal leakage caused by polymerization shrinkage as a problem of resin-based composites.23,24
In determining the restorative material of choice, the dentist should consider the important factor of longevity, because replacement of failed restorations is a burden to patients, practitioners and health care systems. The survival time of restorations generally is shorter in primary and young permanent dentition, with recurrent caries often cited as the most common reason for replacement.23,2530 For primary dentition, differences in longevity between amalgam and resin-based compomer are difficult to determine from previous studies, mainly because studies using the split-mouth design have been limited by small sample sizes, and retrospective studies using chart reviews are subject to bias by confounding factors associated with receipt of treatment.7 In their study of restorations in young dentition, Forss and Widstrom26 concluded that tooth-colored restorative materials may be less durable than amalgam in pediatric patients. In particular, compomers longevity may be more compromised in technically difficult situations (such as lack of patient cooperation, difficulty in isolating the tooth).23,28 On the other hand, studies that limited variability by using split-mouth designs showed comparable retention rates for compomer and amalgam during 24- to 36-month periods and suggested that compomer restorations had better marginal adaptation or surface texture.3133
Regarding posterior permanent teeth, researchers who conducted a systematic review found insufficient evidence from well-controlled studies to establish whether amalgam and resin-based composite have comparable longevity, but they cited several retrospective studies that reported a longer survival time for amalgam.34 A 17-year longitudinal study published in 2003 found a significantly higher survival time for extensive amalgam restorations than for extensive composite restorations.35 Because a variety of factors are associated with placement of amalgam or composite in children, results from studies in which investigators did not control for such factors may be biased in either direction, and the studies have not addressed the issue of longevity adequately.36,37
Our objective in this article is to clarify the issue of restoration longevity by using a randomized clinical trial to compare the replacement rates of restorative material in childrens posterior teeth. The New England Childrens Amalgam Trial (NECAT) randomly assigned children aged 6 to 10 years to groups receiving restorations of either amalgam or resin-based compomer/composite material and prospectively followed them for approximately five years, thus providing an unbiased method to evaluate the durability of the materials.
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METHODS
TOP
ABSTRACT
METHODS
RESULTS
DISCUSSION
CONCLUSION
REFERENCES
Study design and participants.
NECAT was a randomized controlled trial of neuropsychological and renal effects of dental amalgams in children. Detailed descriptions of the design of NECAT have been published.1,38 The study was approved by the institutional review boards of the New England Research Institutes, Watertown, Mass.; The Forsyth Institute, Boston; and all participating dental clinics. English-speaking children aged 6 to 10 years at baseline were eligible if they had no known prior or existing amalgam restorations, more than two posterior teeth with dental caries requiring restorations on occlusal surfaces and no clinical evidence of existing psychological, behavioral, neurological, immunosuppressive or renal disorders. We screened 5,116 children for eligibility. The screening process and baseline visits included a dental examination by a NECAT dentist, radiographs, standard preventive dental care (such as cleaning, application of fluoride and sealants), phlebotomy, urine sample, anthropometric measurements, health interviews and neuropsychological testing of the child and his or her guardian. We confirmed eligibility for 598 children and obtained parental consent and child assent for 534 children (Figure 1
).
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five carious teeth) by using randomly permuted blocks within each of the four strata. In Maine, children were seen at the nonprofit Franklin County Dental Center (Mt. Blue Health Center, Farmington). Boston clinics included three private, nonprofit community health centers (Codman Square Health Center, Dorchester; South Boston Community Health Center, South Boston; Windsor Street Health Center, Cambridge), as well as the Childrens Hospital Boston and the independent Forsyth Institute. One dentist (J.A.S.) treated 97 percent of the Boston-area participants (two additional dentists treated only the seven children who attended the Childrens Hospital Boston), and three dentists treated rural Maine participants during the course of the trial. Clinical variability was minimized by centralized training of all dental personnel and the use of standard pediatric dental procedures, specified in the NECAT protocol and procedures manual. NECAT provided clinics with dentists and materials; any remaining costs were billed to third-party payers. For children assigned to the resin-based compomer/composite group, NECAT dentists placed compomer in all primary dentition and composite in all permanent dentition. For children in the amalgam group, NECAT dentists used compomer or composite in posterior dentition if required by standard clinical practice guidelines.
We scheduled a complete dental examination for each participant every six months during the five-year trial. The study dentists placed restorations continually during the course of the trial as needed, according to the assigned treatment. Restorations could cover multiple surfaces, and the dentists classified restoration size as small (one-quarter of the surfaces or less), medium (between one-quarter and one-half of the surfaces) or large (one-half of the surfaces or more). The dentists repaired restorations when teeth exhibited less than ideal marginal adaptation and/or stained margins.39 If a restoration required replacement, the dentists categorized the reason for replacement as one of the following: new caries, recurrent caries, fracture, restoration loss or other. The dentists used the criterion of "new caries" when the carious surface was different from the one previously restored on the same tooth. The dentists recorded exact dates of dental visits, replacements, repairs and extractions.
The dentists used the same technique when placing all restorations, using rubber dams most of the time. After completely removing carious matter, the dentist acid-etched the tooth with 30 percent phosphoric acid for 20 seconds and washed it thoroughly. He or she applied a bonding agent (Optibond, Kerr, Orange, Calif.) and light-cured it for 30 seconds. The dentist then placed the restoration according to the manufacturers indications using Dispersalloy (Dentsply/Caulk, Milford, Del.) for the amalgam restorations, Dyract (Dentsply/Caulk) for the compomer restorations and Z100 (3M ESPE, St. Paul, Minn.) for the composite restorations.
Statistical analysis. We collected data for each restoration from the date of initial placement to the date of replacement, repair, extraction, exfoliation or the childs last dental visit (whether at year 5 or before withdrawal from the trial), whichever occurred first. Because the study dentists placed restorations at the baseline dental visits as well as during follow-up visits throughout the five-year trial, the start of follow-up time could vary for each restoration. We estimated the date of exfoliation by averaging the date of the last dental visit with the primary tooth with the date of the first dental visit with the corresponding permanent tooth. Because the dentist performed dental examinations every six months and documented the status of each tooth, the date of exfoliation is accurate to within three months. We excluded from all analyses any restorations placed with no subsequent follow-up (placed at the last dental visit before withdrawal from the study, before tooth exfoliation or at the end of the trial).
The analysis for permanent teeth consisted of two main outcomes: rate of replacement and rate of repair. In the main analysis for primary teeth, we considered only the rate of replacement, as we made no repairs on restorations in primary posterior teeth. We compared rates of extraction in an additional analysis because primary teeth containing restorations in need of replacement may have been extracted if the tooth was close to exfoliation.
To evaluate whether the rate of replacement and/or repair varied by type of restoration material, we used a random effects accelerated failure time model with proportional hazards. The random effect was the participant, to account for correlations between restorations in the same mouth. The models adjusted for the following covariates when they were significant or changed the effect of the restoration material by more than 10 percent: age, sex, socioeconomic status and the number of restorations (of either type) in the mouth.
In our sensitivity analyses of primary teeth, we examined first and second primary molars separately. In sensitivity analyses of permanent teeth, we restricted the analyses to restorations that were placed at baseline and for which we had five-year follow-up data. In additional analyses, we evaluated the association between the size of the restoration and the need for replacement by adding it into the multivariate models. Here, we used only the subset of patients seen by a single dentist (J.A.S., the primary dentist in Boston) (n = 1,044 restorations in primary teeth, 875 restorations in permanent teeth), because size classification may be subjective. We used a repeated-measures logistic regression model with compound symmetric variance structure, which accounts for correlations within the same child, to compare reasons for replacement between materials.
| RESULTS |
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At baseline, the average age of participants was 7.9 years (with a standard deviation [SD] of 1.3 years in the amalgam group and 1.4 years in the composite group) (Table 1
). The mean number of carious tooth surfaces at baseline was 9.5, of which 7.8 were in primary teeth and 1.7 in permanent teeth. Children in the two treatment groups were similar in terms of baseline characteristics, including age, race, household income, education of primary caregiver and number of carious tooth surfaces. The numbers of girls and boys were comparable in the amalgam group, but girls outnumbered boys in the composite group.
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Restorations in primary teeth.
Replacement of restorations.
The percentage of restorations replaced during the trial was greater for resin-based compomers (5.8 percent) than for amalgams (4.0 percent) (Table 2
). Figure 2
displays the rates of replacements for all restorations. The difference in longevity became noticeable between one and two years after placement and persisted until the end of the trial, although it failed to reach statistical significance in the random effects survival model (P = .10). The need for replacement increased with the number of restorations in the mouth (P < .001).
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Overall, reasons for replacement varied significantly with the restorative material (P = .04) (Table 3
). Almost one-half (47 percent) of amalgam replacements were the result of new caries, whereas resin-based compomer replacements most often (52 percent) were caused by recurrent caries. Considering that recurrent caries is likely to be the most relevant reason for restoration replacement in a comparison of restorative materials and replacement rates, we conducted an exploratory subanalysis. We found that 3.0 percent of the compomer restorations were replaced owing to recurrent caries, compared with 0.5 percent of the amalgam restorations (Table 2
), a sixfold increase. As seen in Figure 3
, replacements due to recurrent caries were more common among compomer restorations as early as one year after placement, and this difference grew substantially through follow-up (P = .002).
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Extractions. Posterior teeth restored with compomers were more likely to be extracted at a later point than were those restored with amalgam (10.7 percent of compomer restorations versus 7.2 percent of amalgam restorations; data not shown). This difference was due mainly to the extraction of mandibular second molars (13.6 percent of compomers versus 3.8 percent of amalgams).
Restorations in permanent teeth.
Replacement of restorations.
Replacement was more frequent among resin-based composite restorations, with 14.9 percent of composite restorations replaced compared with 10.8 percent of amalgam restorations (Table 2
). Although there was a noticeable difference in longevity two years after placement (Figure 4
), this difference was not statistically significant in the random effects survival model (P = .45). When we restricted the analysis to restorations with five years of follow-up data, we found that 21.9 percent of composite restorations were replaced, compared with 15.9 percent of amalgam restorations (P = .61; data not shown). In both models, the need for replacement increased with the number of restorations in the mouth (P < .001).
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There were no statistically significant differences in reasons for replacement by restorative material. The most common reasons were new caries and recurrent caries (Table 3
).
Repair of restorations.
The percentage of repairs was significantly higher for composites (2.8 percent) than for amalgams (0.4 percent) (P = .02; Table 2
). Figure 5
depicts the rates of repair for amalgam and composite restorations. After 2.5 years, a wide divergence that grew with increasing follow-up time is notable. Among the restorations with five years of follow-up data, repair rates were 4.0 percent versus 0.5 percent (P = .13; data not shown).
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| DISCUSSION |
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Although the difference in replacement rates between amalgam and composites was not statistically significant itself, the widening gap between materials in the survival analysis curves and the significant difference in repair rates suggest that with longer follow-up, differences in replacement rates could become significant. Studies show that the strength of a repaired composite tends to be substantially compromised, compared with the original restoration.4244 Although it is accepted clinical practice that composite restorations are more amenable to repair, whereas amalgam restorations more often are replaced, this practice alone cannot explain the striking difference in the rate of repairs in our study. In NECAT, the study dentists repaired composite restorations primarily because of marginal defects (as noted by J.A.S.), whereas they repaired amalgams only rarely. Regardless of the reason, the fact that composites more frequently required repair is a substantial disadvantage, because each repair requires time and materials and, therefore, increases the cost of dental care.
It is possible that primary teeth with restorations in need of replacement were extracted, rather than the restoration replaced, if the tooth was close to exfoliation. We did not record reasons for extractions, thereby limiting our ability to analyze the need for replacement. However, the finding that extracted teeth were more likely to have been restored with compomer than with amalgam provides additional evidence of a lower longevity for resin-based compomer, because the actual difference in replacement between compomer and amalgam may be greater than what we observed.
An evaluation of the reasons for replacement provides insight into the suitability of restorative materials. For example, our finding that compomer was replaced most often because of recurrent caries suggests that compomer may not be ideal for restorations in posterior primary teeth. Compomer shrinks, which may compromise the restoration and facilitate recurrence of caries.45 In addition, compomers and composites are especially technique-sensitive and thus may be more difficult to place in young or uncooperative children.19,26,30 The finding that most amalgam replacements in primary teeth were necessitated by new caries suggests both an advantage (that is, recurrent caries was not much of an issue), as well as a disadvantage (in that amalgams must be replaced often to facilitate restoration of new caries). Thus, the advantages and disadvantages of each material can be weighed by considering the reasons for differences in longevity, as well as the observed differences in replacement rates.
Our results are consistent with previous reports suggesting that the longevity of amalgam is higher than that of resin-based compomer in primary teeth26 and composite in permanent teeth.30,40 However, other studies failed to find differences in longevity for restorations in primary dentition, and some noted potential advantages of compomer over amalgam, such as improved marginal adaptation.3133 The lack of a clear consensus on the issue of longevity from previous studies results from varied clinical methods and materials, limited sample sizes and follow-up, and the potential for confounding. In our study, the randomization of treatment ensured that children would be balanced in terms of factors that may be related to longevity of restorations. We also minimized clinical variability by using mainly one dentist at the Boston study site and just three at the Maine site. However, the use of only one type of compomer and one type of composite may limit our ability to generalize to all compomer/composite materials. Similarly, longer follow-up would have improved our ability to assess the longevity of materials in permanent teeth. Future studies of restoration longevity in childrens dentition should include children younger than 6 years to allow for maximal follow-up time of restorative materials in primary teeth as well.
| CONCLUSION |
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These findings from a randomized clinical trial in New England are the first to document, without bias, that compomer/composite restorations in pediatric patients may require more procedures than do amalgam restorations to maintain their integrity. In addition to longevity, dentists should consider the diagnosis, ease of material placement, oral hygiene, risk profile for future caries, esthetic demands and financial considerations in weighing advantages and disadvantages of compomer, composite and amalgam restorative materials.
| FOOTNOTES |
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| REFERENCES |
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This article has been cited by other articles:
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J.L. Drummond Degradation, Fatigue, and Failure of Resin Dental Composite Materials J. Dent. Res., August 1, 2008; 87(8): 710 - 719. [Abstract] [Full Text] [PDF] |
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