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Does Fluoride in Compomers Prevent Future Caries in Children?

F. Trachtenberg, N.N. Maserejian, J.A. Soncini, C. Hayes and M. Tavares J DENT RES 2009 88: 276 DOI: 10.1177/0022034508330884 The online version of this article can be found at: http://jdr.sagepub.com/content/88/3/276

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RESEARCH REPORTS
Clinical

F. Trachtenberg1*, N.N. Maserejian1, J.A. Soncini2,3, C. Hayes4, and M. Tavares2

New England Research Institutes, 9 Galen Street, Watertown, MA 02472, USA; 2 The Forsyth Institute, Clinical Collaborative, Boston, MA, USA; 3 Boston University School of Dental Medicine, Department of Pediatric Dentistry, Boston, MA, USA; and 4 Tufts University School of Dental Medicine, Department of Public Health and Community Service, Boston, MA, USA; *corresponding author, ftrachtenberg@ neriscience.com
1

Does Fluoride in Compomers Prevent Future Caries in Children?

INTRODUCTION

J Dent Res 88(3):276-279, 2009

Abstract
Compomer restorations release fluoride to help prevent future caries. We tested the hypothesis that compomer is associated with fewer future caries compared with amalgam. The five-year New England Childrens Amalgam Trial recruited 534 children aged 6-10 yrs with 2 carious posterior teeth. Children were randomized to receive compomer or amalgam restorations in primary posterior teeth, placed with a fluoride-releasing bonding agent. The association between restorative material and future caries was assessed by survival analysis. Average follow-up of restorations (N = 1085 compomer, 954 amalgams) was 2.8 + 1.4 yrs in 441 children. No significant difference between materials was found in the rate of new caries on different surfaces of the same tooth. Incident caries on other teeth appeared slightly more quickly after placement of compomer restorations (p = 0.007), but the difference was negligible after 5 yrs. Under the conditions of this trial, we found no preventive benefit to fluoride-releasing compomer compared with amalgam.

KEY WORDS: compomers; dental amalgam;

dental caries; dentition, primary; clinical trial.

DOI: 10.1177/0022034508330884 Received June 22, 2007; Last revision September 24, 2008; Accepted December 14, 2008

ompomer dental restorations were developed to combine the mechanical and esthetic properties of composites with the fluoride-releasing advantage of glass-ionomer cements. The fluoride released into the mouth by compomer is intended to help protect against future caries (Eichmiller and Marjenhoff, 1998; Burke et al., 2006). It has been shown that compomer does in fact release fluoride into the mouth (Chung et al., 1998; Grobler et al., 1998; Ylp and Smales, 1999; Karantakis et al., 2000; Asmussen and Peutzfeldt, 2002; Marczuk-Kolada et al., 2006), which has a preventive effect against future caries compared with composite materials without fluoride (Chung et al., 1998; Dionysopoulos et al., 1998; Donly and Grandgenett, 1998; Hicks et al., 2000; Torii et al., 2001; Attar and Onen, 2002; Gonzalez Ede et al., 2004; Yaman et al., 2004). Two survey articles (Burke et al., 2006; Wiegand et al., 2006) concluded that although fluoride-releasing materials, including compomer, inhibit the formation of caries in vitro, such effects have not yet been determined in vivo. Additionally, there is very limited literature comparing compomer with amalgam in this regard, despite the continued widespread use of amalgam for dental restorations. Although amalgam contains no fluoride to protect against future caries, it has very different properties compared with compomer/composite, which may protect against future caries by other means. One prior study (Marks et al., 1999) has compared recurrent caries by compomer and amalgam materials in primary molars using a split-mouth design. After 3 yrs of follow-up, out of 17 restorations with each material, one restoration of each type required replacement due to recurrent caries. However, the sample size of this study was too small for a small to moderate effect to be detected. Therefore, the relative potential for prevention of future caries for compomer and amalgam has not yet been well-established. The purpose of this analysis is to compare the incidence of new caries after children are randomized to receive compomer or amalgam restorations, with data collected prospectively as part of the New England Childrens Amalgam Trial (NECAT). Data from this trial have already shown a greater need for replacement of primary posterior restorations due to recurrent caries on the same tooth surface after placement of compomer compared with amalgam restorations (3.0% vs. 0.5%, p = 0.002) (Soncini et al., 2007). This finding may have resulted from properties of compomer restorations, such as microleakage, outweighing any potential beneficial effects of released fluoride. However, it remains possible that fluoride from compomers succeeds in protecting other teeth in the mouth. It is important to examine this possibility because, if there is a benefit to compomer over amalgam in preventing future caries on other surfaces, such a benefit may outweigh the risk of more frequent replacement of compomers. Indeed, an assessment of dental material choice must consider the overall picture of future dental procedures, including new restoration placement as well as replacement of existing restorations.

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J Dent Res 88(3) 2009

Fluoride in Compomers and Future Caries 277

the first dental visit with the corresponding permanent tooth; since dental exams were performed every 6 mos and documented the status of each tooth, the date of exfoliation is accurate to within 3 mos. Restorations placed with no subsequent follow-up (i.e., at the last dental visit before withdrawal, tooth exfoliation, or at the end of the trial; N = 80) were excluded from all analyses and descriptive statistics. The time from placement of each restoration to the development of each new carious surface recorded while the initial restoration was still in the mouth was calculated. There were two outcomes for this analysis: the times until (1) new caries on a different surface of the same tooth, and (2) new caries on any different teeth. To test whether these outcomes varied by type of restoration material (compomer vs. amalgam, as treated), we used a random-effects accelerated failure time model with proportional hazards (Cox and Oakes, 1984). The models adjusted for the following covariates when they were significant (p < 0.05) or changed the effect of restoration material by > 10%: age, gender, socio-economic status (a weighted average of household income and education), and the number of restorations (of either type) in the mouth at the time the restoration was placed. The random effect in this survival model was the child, to account for the potential correlation between restorations in the same mouth. Survival curves were plotted to show the percents of compomer and amalgam restorations that had future caries develop either on the same tooth or on different teeth after placement through the follow-up time period.

MATERIALS & METHODS

Study Design and Participants
A detailed discussion of the design of NECAT has been previously published (The Childrens Amalgam Trial, 2003; Bellinger et al., 2006). The study was approved by the institutional review boards of the New England Research Institutes, The Forsyth Institute, and all dental clinics. English-speaking children in Boston, MA, and Farmington, ME, aged 6-10 yrs at baseline, were eligible if they had no known prior or existing amalgam restorations, 2 posterior teeth with dental caries requiring restorations on occlusal surfaces, and no clinical evidence of existing psychological, behavioral, neurological, immunosuppressive, or renal disorders. Parental consent and child assent were obtained for 534 children.

Dental Treatment and Clinical Procedures

A complete dental examination was scheduled every 6 mos during the five-year trial, between September 1997 and March 2005. Participating children were provided preventive and restorative dental care. Sealants (Ultradent XT plus; Ultradent, South Jordan, UT, USA ) were placed on all sound permanent and primary molars with deep pits and fissures and were replaced as needed in all children. Restorations were continually placed over the course of the trial as needed, according to assigned treatment. Children were randomized to receive either amalgam (n = 267) or composite/compomer (n = 267) restorations at baseline and during the course of the trial. For children assigned to the composite/ compomer group, compomer was placed in primary dentition, while composite was placed in permanent dentition. For children in the amalgam group, composite/compomer was used in the anterior dentition if required by standard clinical practice guidelines. The amalgam material used was Dispersalloy (Dentsply Caulk, Milford, DE, USA), and the compomer material was Dyract (Dentsply Caulk). One dentist (J.A.S.) treated 97% of the Boston-area participants, with two additional dentists treating the remaining seven children at one Boston site. 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 as specified in the NECAT protocol and procedures manual. The same technique was used in the placement of all restorations, with rubber dam used the majority of the time. Following the complete removal of decay, the tooth was acid-etched with 30% phosphoric acid for 20 sec and washed thoroughly. A bonding agent (Optibond; Kerr, Orange, CA, USA) that has a fluoride-release characteristic was applied and light-cured for 30 sec. The restoration was then placed according to the manufacturers indications. Although fluoride-containing bonding agents are less commonly used in the placement of amalgam compared with compomer restorations, the use of bonding agents had to be standardized in this clinical trial (designed to compare the safety of the two types of materials themselves), to eliminate possible confounding (e.g., by bonding agent).

RESULTS
At baseline, the average age of participants was 7.9 + 1.3 yrs (Table). The mean number of total caries at baseline was 9.5 decayed tooth surfaces, of which 7.8 were in primary teeth and 1.7 were in permanent teeth. The sample was gender-balanced and racially diverse. Over the five-year trial, 1085 compomer and 954 amalgam restorations with follow-up were placed on posterior primary surfaces in 441 children (243 receiving compomer, 218 receiving amalgam, with 20 receiving both). The average length of restoration follow-up was 2.8 + 1.4 yrs, with a range of 0.03-6.3 yrs. Although this was a five-year study with dental visits every 6 mos, children sometimes scheduled visits at longer intervals, resulting in greater than 5 yrs of follow-up. Survival curves for time until new caries after placement of either compomer or amalgam restorations were plotted by treatment group (Fig.). Random-effects survival analysis showed no significant effect of dental material on new caries on the same tooth (p = 0.98, Fig., a). However, there was a very small, but statistically significant (p = 0.007), effect of dental material on new caries formed on different teeth, with longer time until the formation of new caries following placement of amalgam restorations (Fig., b). In comparison of new caries following those primary restorations with five-year follow-up (N = 211: 109 composite + 102 amalgam), amalgam was associated with a slightly higher percentage of new caries on different surfaces of the same tooth after 5 yrs of follow-up (17.7% vs. 14.7% of restorations). The mean number of new caries on different teeth 5 yrs after restoration placement was also slightly higher for amalgam (4.2 vs. 3.5 new carious surfaces). In analyses that examined the percentage of sound teeth in the mouth at baseline that developed caries during the five-year follow-up, there was no difference by restoration material; 8.5% of sound teeth in either arm developed caries. This relatively low percent may be explained by the exfoliation of sound primary teeth over the five-year follow-up. Almost all children presented with caries during follow-up,

Statistical Analysis
Only exposure to posterior primary restorations was considered for this analysis, since NECAT used compomer only in primary teeth and amalgam only in posterior teeth. However, determination of future caries, after placement of the restoration, included all teeth (including permanent and anterior teeth). Each restoration contributed follow-up from the date of initial placement to the date of exfoliation, extraction, or the childs last dental visit (whether at year 5 or before withdrawal from the trial), whichever occurred first. Because restorations were placed at the baseline dental visit, as well as during follow-up visits over the five-year trial, the start of follow-up time varied by restoration. We estimated the date of exfoliation by averaging the dates of the last dental visit with the primary tooth and

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278

Trachtenberg et al.

J Dent Res 88(3) 2009

follow-up, the mean number of new caries on other teeth or on other surfaces in the same tooth after placement of Baseline Characteristic Amalgam Group (n = 267) Composite Group (n = 267) compomer was actually slightly lower, compared with amalgam. Thus, overall, Study site, n (%) there was no clear or consistent effect of Boston 144 (53.9) 147 (55.1) these dental materials on the formation of Maine 123 (46.1) 120 (44.9) new caries on different surfaces/teeth in Carious surfaces, our study. We conclude that there does mean (SD) range 9.8 (6.9) 2-39 9.3 (6.2) 2-36 not appear to be an advantage to the Age, mean (SD), yrs 7.9 (1.3) 7.9 (1.4) Gender, n (%) fluoride-releasing com pomer compared Female 131 (49.1) 156 (58.4) with amalgam resto rations placed with Male 136 (50.9) 111 (41.6) the Optibond bonding agent for the Race, n (%)b prevention of new caries in children. Non-Hispanic white 165 (64.0) 158 (60.3) A limitation in the generalizability of Non-Hispanic black 49 (19.0) 49 (18.7) these findings is that a bonding agent Hispanic 15 (5.8) 23 (8.8) (Optibond) with a fluoride-release Other 29 (11.2) 32 (12.2) characteristic was used for all resto rations, Household income, n (%) such that all restored surfaces received $20,000 74 (29.2) 86 (33.1) some fluoride exposure. Addi tionally, the $20,001 - $40,000 113 (44.7) 109 (41.9) sealant used on children in both treatment > $40,000 66 (26.1) 65 (25.0) groups also released fluoride into the Education of primary caregiver, n (%) mouth. Therefore, this was a comparison < High school 34 (13.2) 38 (14.6) of compomer and amalgam in an oral High school graduate 197 (76.4) 194 (74.3) environment that had an unmeasured, but College graduate 18 (7.9) 17 (6.5) relatively constant, base level of fluoride. Post-college degree 9 (3.5) 12 (4.6) However, the Optibond bonding agent a  For race, data were available for 520 participants (N = 520); for income, N = 513; for education, releases fluoride into the tooth, as opposed N = 519. to the compomer restoration, which b  Race was self-reported by the parents of the children. releases fluoride into the mouth, resulting in a different route of fluoride exposure. It is possible that either the small amount of fluoride released though often on teeth that were either already decayed or not into the tooth from the Optibond liner protects against future caries present in the mouth at baseline. in a magnitude similar to the fluoride-releasing properties of compomer, or, despite the received benefit of additional fluoride DISCUSSION from compomer, compomer is still no more successful at preventing This paper presents, for the first time in a large sample, analyses future caries due to other properties. For example, the problem of to compare the formation of future caries after placement of microleakage, common to compomer and composites, may be a compomer vs. amalgam restorations. The NECAT data allowed factor contributing to the formation of recurrent caries (Burgess et al., us to investigate this association properly, in vivo, by recruiting 2002; Estafan and Agosta, 2003; Soncini et al., 2007). It has been a large cohort of children with a high rate of initial rest orations, noted that despite the cariostatic effects possibly achieved from randomly assigning them to amalgam or compomer, thus removfluoride-releasing materials, secondary caries is still one of the main ing selection biases, and providing regular dental care during the reasons for clinical failure of restorations (Wiegand et al., 2006). course of the five-year trial. Additional study comparing compomer with amalgam in This dataset previously showed greater need for replacement other oral environments would be worthwhile. Still, because of primary posterior restorations due to recurrent caries on the children with multiple dental treatment needs, as in our study, same tooth surface after placement of compomer compared with are most in need of protection against future caries, the use of amalgam restorations (3.0% vs. 0.5%, p = 0.002) (Soncini et al., fluoride agents at various levels of treatment may represent an 2007). Adding to this, the current analysis demonstrated that, increasingly common standard of care (American Academy of under the restoration placement conditions of the trial, there was Pediatric Dentistry, 2005). In light of our findings, the evidence no protective effect of compomer relative to amalgam in its ability to date suggests no advantage of compomer over amalgam in to prevent future caries on different surfaces/teeth. Rather, incident protecting against the formation of future caries. Therefore, caries on other teeth (i.e., other than the tooth where the restoration although there is reason to prefer the use of compomer rather was placed) appeared more quickly after the placement of than composite in primary teeth, because of the cariostatic compomer restorations, but the difference, though statistically property of fluoride (Chung et al., 1998; Dionysopoulos et al., significant, was very small, and the survival curves showed little 1998; Donly and Grandgenett, 1998; Hicks et al., 2000; Torii difference between compomer and amalgam at the end of et al., 2001; Attar and Onen, 2002; Gonzalez Ede et al., 2004; follow-up. In contrast, among restorations with a full 5 yrs of Yaman et al., 2004), compomer does not perform better than
Table. Baseline Characteristics of New England Childrens Amalgam Trial Participants (N = 534), by Assigned Treatmenta

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J Dent Res 88(3) 2009

Fluoride in Compomers and Future Caries 279

% of restorations with new caries on different surfaces of the same tooth

amalgam in this respect when amalgam is placed with a fluoride-releasing bonding agent. Considering the results presented here, together with our previously published results on new restoration placement and replacement of existing restorations (Soncini et al., 2007), our study suggests that placement of compomer restorations in a high-risk population results in more future dental needs compared with amalgam.

a
compomer amalgam 15

10

ACKNOWLEDGMENTS
The study was supported by the National Institute of Dental and Craniofacial Research, Bethesda, MD, USA (U01 DE11886), which also participated in the design and conduct of the study. Trial Registration: Health Effects of Dental Amalgams in Children, NCT00065988, http://www.clinicaltrials.gov/ct/show/ NCT00065988?order=1

0 0 1 2 3 4 5 years since placement of restoration 6

b
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% of restorations with new caries on a different tooth

100 80 60 40 20 0 0

compomer amalgam

1 2 3 4 5 years since placement of restoration

Figure. Rates of new caries after restoration placement, by treatment group, in the New England Childrens Amalgam Trial (N = 2039 restorations). (a) Rate of new caries on a different surface of the same tooth. P = 0.98, calculated from a random-effects accelerated-failure time model with proportional hazards, adjusted for gender, socio-economic status, and number of decayed and filled surfaces in the mouth. (b) Rate of new caries on a different tooth. P = 0.007, calculated from a random-effects acceleratedfailure time model with proportional hazards, adjusted for age. Marks LA, Weerheijm KL, van Amerongen WE, Groen HJ, Martens LC (1999). Dyract versus Tytin Class II restorations in primary molars: 36 months evaluation. Caries Res 33:387-392. Soncini JA, Maserejian NN, Trachtenberg F, Tavares M, Hayes C (2007). The longevity of amalgam versus compomer/composite restorations in posterior primary and permanent teeth: findings from the New England Childrens Amalgam Trial. J Am Dent Assoc 138:763-772. Torii Y, Itota T, Okamoto M, Nakabo S, Nagamine M, Inoue K (2001). Inhibition of artificial secondary caries in root by fluoride-releasing restorative materials. Oper Dent 26:36-43. Wiegand A, Buchalla W, Attin T (2006). Review on fluoride-releasing restorative materialsfluoride release and uptake characteristics, antibacterial activity and influence on caries formation. Dent Mater 23:343-362. Yaman SD, Er O, Yetmez M, Karabay GA (2004). In vitro inhibition of caries-like lesions with fluoride-releasing materials. J Oral Sci 46: 45-50. Ylp HK, Smales RJ (1999). Fluoride release and uptake by aged resinmodified glass ionomers and a polyacid-modified resin composite. Int Dent J 49:217-225.

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