PEDIATRIC DENTISTRY V 36 / NO 1 JAN / FEB 14

Clinical Article RANDOMIZED CONTROL TRIAL

Dental Sealants and Flowable Composite Restorations and Psychosocial, Neuropsycho-

logical, and Physical Development in Children
Nancy N. Maserejian, ScD1 • Peter Shrader, MA2 • Felicia L. Trachtenberg, PhD3 • Russ Hauser, MD, ScD, MPH4 • David C. Bellinger, PhD, MSc5 •
Mary Tavares, DMD, MPH6

Abstract: Purpose: Dental sealant materials may intraorally release their components, including bisphenol-A (BPA), but long-term health effects
are uncertain. The New England Children’s Amalgam Trial (NECAT) found that composite restorations were associated with psychosocial, but not
neuropsychological or physical, outcomes. The previous analysis did not consider sealants and preventive resin restorations (PRRs), which were
routinely placed. The purpose of this analysis was to examine sealant/PRR exposure in association with psychosocial and other health outcomes.
Methods: NECAT recruited 534 six- to 10-year-olds and provided dental care during a five-year follow-up. Annually, examiners conducted psycho-
social and neuropsychological tests and measured body mass index (BMI) and fat percentage (BF%). Associations between surface years (SY) of
sealants/PRRs and outcomes were tested using multivariable models. Results: Cumulative exposure level to sealants and/or PRRs was not asso-
ciated with psychosocial assessments (eg, total problems: Child Behavior Checklist, 10-SY β=-0.2±0.3,P=.60) or neuropsychological tests (eg, full-
scale IQ, 10-SY β=0.1±0.2, P=.60). There were no associations for changes in BMI-for-age z-score (P=.40), BF% (girls 10-SY β=-0.2±0.3; boys 10-SY
β=-0.1±0.3), or menarche (10-SY hazard ratio=0.91, 95% confidence interval=0.83-1.01, P=.08). Conclusions: This study showed no associations
between exposure level of dental sealants or PRRs and behavioral, neuropsychological, or physical development in children over 5-years. (Pediatr
Dent 2014;36:68-75) Received June 26, 2013 | Last Revision October 25, 2013 | Accepted October 25, 2013
KEYWORDS: COMPOSITE DENTAL RESIN, BISPHENOL A-GLYCIDYL METHACRYLATE, CHILD BEHAVIOR, EXECUTIVE FUNCTION, BODY COMPOSITION

Dental sealants on primary and permanent molar teeth are an
important component of children’s oral health and caries pre-
vention.1-3 Despite their proven benefits, recent concerns re-
garding chemical exposures from dental materials have resulted
from laboratory findings indicating that the resins used in
sealants are possible exposure sources to bisphenol-A (BPA) and
other compounds that have potentially adverse effects.4-7 BPA
is a well-known endocrine disruptor and causes a variety of
adverse health effects at low dose exposure levels in laboratory
animal experiments.8
The main monomer used in many manufactured sealants
today, bisphenol-A-glycidyl-dimethacrylate (bisGMA), has also
been shown to cause local cytotoxicity, DNA damage, and estro-
genic activity.9-13 For example, bisGMA exposure significantly
reduced fertility, sperm counts, weights of testis and preputial
glands, and overall body weight in adult male mice14 and signi-
ficantly increased embryo resorption rates and ovary weights in
adult female mice.15 Observational human cohort studies have
identified associations between urinary BPA levels and various
adverse health measures, ranging from behavior problems in
children to coronary artery disease in adults.16-22 However, addi-
tional longitudinal studies are needed to help examine causal
associations.
1 Dr. Maserejian is a senior research scientist and an associate director, Department of
Epidemiology, New England Research Institutes, Watertown, and Lecturer, Department of
Oral Health Policy and Epidemiology, Harvard School of Dental Medicine, Boston; 2Mr.
Shrader is a statistician, and 3Dr. Trachtenberg is a senior statistician, New England
Research Institutes; 4Dr. Hauser is a professor, Harvard School of Public Health, Harvard
Medical School, and Massachusetts General Hospital, Boston; 5Dr. Bellinger is a profes-
sor, Harvard School of Public Health, Boston Children’s Hospital, and Harvard Medical
School, Boston; and 6Dr. Tavares is a program director, Advanced Graduate Education
Program in Dental Public Health, Department of Oral Health Policy and Epidemiology,
Harvard School of Dental Medicine, Boston, and a senior clinical investigator, The
Forsyth Institute, Cambridge, all in Mass., USA.
Correspond with Dr. Maserejian at nmaserej@post.harvard.edu
Clinical studies measuring salivary and/or urinary bisGMA,
BPA, and other compounds before and after placement of seal-
ants or composite restorations have shown increased biomarker
levels up to 30 hours after their placement in adults.23-27 Chil-
dren have higher levels of urinary BPA than all other age groups
in the United States and may be most sensitive to exposure
effects.28
Previously, we examined the association of composite re-
storation placement with adverse health outcomes over five years
using data from the New England Children’s Amalgam Trial
(NECAT). NECAT randomized 534 children to receive either
amalgam or composite for posterior tooth restorations, collect-
ing detailed data to allow an examination of treatment levels over
time. While results showed no adverse effects for amalgam,29
children randomized to composites, especially those with greater
exposure to bisGMA-based composites, had worse psychosocial
health measures during follow-up.30,31 Further examination of
neuropsychological test scores and physical development mea-
sures showed no consistent associations between composites
and those outcomes, indicating specificity to behavioral health
effects.32,33
In addition to restorative fillings, all children participating
in NECAT received pit and fissure sealants during the five-year
trial and, as needed, flowable composite for preventive resin
restorations (PRRs) for shallow caries. Compared to composites
used for restorations, sealants are designed to be highly flowable
and facilitate their infiltration onto the surfaces of dental pits
and fissures. The high viscosity of sealants and flowable com-
posites is attained by using substantially greater amounts of
resin monomers that contain bisGMA.
No prior studies have examined exposure to dental sealants
in association with long-term adverse health effects in children.
Therefore, the purposes of this study were to: examine whe-
ther, consistent with previous findings for packable composite

68 DENTAL MATERIALS AND CHILD DEVELOPMENT


restorations in the New England Children’s Amalgam Trial,30,31
treatment levels for flowable composite (sealants and preventive
resin restorations) were associated with behavioral outcome
measures; and evaluate associations between sealants/PRRs and
neuropsychological and physical development measures during
the five-year follow-up.
Methods
Study population. NECAT was a randomized safety clinical
trial of amalgam vs. composite for posterior restorations con-
ducted among 534 children at six community dental clinics in
urban Boston and rural Maine between 1997 and 2005. Eligible
children: were six to 10 years old at baseline; had no existing
amalgam restorations; had more than two posterior teeth with
caries requiring restoration on occlusal surfaces; were fluent in
English; and, according to parental reports, had no physician-
diagnosed psychological, behavioral, neurological, immunosup-
pressive or renal disease. Written informed consent was obtained
from the parent/guardian, and signed assent was obtained
for children who were at least eight years old. The study was
approved by the institutional review boards of the New En-
gland Research Institutes (Watertown, Mass., USA) and all
participating sites. Additional details on the study procedures
have been published.29,34,35
Dental materials and interventions. Participants received
comprehensive dental care semi-annually during their five-year
participation. Standard dental care included exams, cleaning,
fluoride application, sealant placement, and restorative treat-
ment. Dental procedures and materials were standardized
across study sites, following manufacturer’s indications for use.
The flowable composite material used for preventive sealing of
sound pits and fissures of posterior teeth, referred to as a seal-
ant, was Ultraseal XT (Ultradent, South Jordan, Utah, USA).
The flowable composite used for PRRs, which treated shallow,
incipient caries that did not extend into the dentin, was Revo-
lution (Kerr, Orange, Calif., USA). Composite restoration
materials used were Z100 (3M ESPE, St. Paul, Minn., USA) for
permanent teeth and Dyract AP compomer (Dentsply Caulk,
Milford, Del., USA) for primary teeth. Sealants and PRRs were
placed as needed, regardless of assigned treatment group for
restorations.
Health outcome measures. One supervising psychologist
trained and certified examiners to conduct psychosocial and
neuropsychological tests and continuously monitored them for
quality control throughout the trial. The study used two vali-
dated instruments for psychosocial assessments at baseline and
follow-up: (1) the Child Behavior Checklist (CBCL) parent-
report36; and (2) the Behavior Assessment for Children Self-
Report (BASC-SR).37 Both are widely used in screening chil-
dren and adolescents for psychosocial problems, 38 yielding
global T-scores (mean=50±10 standard deviation [SD]) and core
syndrome scores. Based on our previous findings, the primary
outcomes of interest were BASC-SR scores on the four global
scales (total emotional symptoms index, clinical maladjustment,
school maladjustment, personal adjustment) measured at the
end of the five-year follow-up. We did not analyze change since
baseline for BASC-SR, because most (63 pecent) of the subjects
were younger than eight years old at baseline, and BASC-SR
was not developed or validated for children younger than eight
years old. Secondary behavioral outcomes were BASC-SR sub-
scale scores, CBCL change scores, and the percentage of chil-
dren with at-risk or clinically significant scores at the end of
follow-up.
PEDIATRIC DENTISTRY V 36 / NO 1 JAN / FEB 14
For neuropsychological assessments, the study used a bat-
tery of validated tests of executive functioning, intelligence, me-
mory, visual-spatial skills, verbal fluency, and problem-solving,
which together help enhance interpretation of this complex
outcome. 39 Neuropsychological outcomes of interest were:
Wechsler Intelligence Scale for Children (WISC) III full-scale
IQ; factors of verbal comprehension, perceptual organization,
freedom from distractibility, and processing speed; the Wechsler
Individual Achievement Test (WIAT) reading and math scores;
and the following executive function tests—Trail Making Test,
Letter Fluency Subtest of Verbal Fluency, Stroop Color-Word
Interference Test, and Wisconsin Card Sorting Test.
At baseline and annual follow-up visits, NECAT data col-
lectors measured height, weight, and body fat percentage
(BF%), using a calibrated bioimpedance scale (model no. TBF-
551, Tanita Corp of America, Inc, Arlington Heights, Ill.,
USA). 40 We calculated body mass index (BMI; kg/m 2) and
BMI-for-age z-score using the Centers for Disease Control data
files, defining overweight or obese as a BMI-for-age z-score
greater than 85th percentile.41,42 Female participants reported
menarche status annually as no/yes and, if yes, month and year
of menarche.
Statistical analysis and power. We excluded children
who were missing data on placement of sealants (n=44), PRR
(n=7), or both (n=33), resulting in 450 children in the total
analytic cohort. We initially examined sealants and PRRs se-
parately and then combined them to create a measure of total
flowable composite exposure. We did this because both con-
tained bisGMA as a primary source monomer according to the
material safety data sheets and because PRRs were often placed
using the same material as that used for preventive sealants.
We calculated the cumulative treatment levels per subject using
a surface years (SY) measure, which takes each treated surface
and weights it by the length of time that it was present in the
mouth. We categorized surface years into four categories: none,
and among the exposed, tertile of exposure level.
For each health outcome, we conducted statistical analyses
separately and excluded children with missing outcome data
(see results tables for sample sizes in each analysis). Numerous
sensitivity analyses were conducted, such as:
1. excluding children (n=39) who had pre-existing seal-
ants at baseline;
2. excluding children (also n=39, coincidentally) who
had no sealants or PRRs during the study, because
this deviation from standard clinical procedures may
indicate an unmeasured source of confounding from
children in this minority; and
3. for analyses of psychosocial outcomes, excluding 302
children who ever received composite restorations dur-
ing the study, given our previously reported findings
of an association between composite restorations and
psychosocial measures.
Results of these sensitivity analyses confirmed those of the
primary analyses and, therefore, are not presented.
Outcomes were analyzed as changes in score between base-
line and follow-up for all measures except the BASC-SR (as
explained previously) and in the exploratory analysis of me-
narche. Physical development outcomes were analyzed separately
for boys and girls. Repeated measurements of BF% and BMI
based on annual study visits were used in linear mixed effects
models. Models included: subject-specific intercepts to account
for natural heterogeneity in the population; age-specific slopes
to account for differences in growth trajectory by baseline age;
and, if statistically significant, piece-wise linear splines to account
DENTAL MATERIALS AND CHILD DEVELOPMENT 69
PEDIATRIC DENTISTRY V 36 / NO 1 JAN / FEB 14

Table 1. BASELINE CHARACTERISTICS OF PARTICIPANTS, OVERALL AND

BY TOTAL CUMULATIVE EXPOSURE (SURFACE YEARS) TO FLOW- for changes in growth at puberty. 43 Age at menarche was
ABLE COMPOSITES (SEALANTS OR PREVENTIVE RESIN analyzed among girls from the Maine clinical site only
RESTORATIONS [PRRs]) DURING THE 5-YEAR TRIAL (n=113), because menarche data collection was incomplete
at the Boston site.
Total By sealant/PRR exposure level We examined associations using multivariable models
(surface years category)
adjusting for relevant sociodemographic and dental vari-
Tertile among exposed ables. The following variables were included in the multi-
0 Tertile 1 Tertile 2 Tertile 3 variable models, depending on the outcome of interest:
0.1-33.9 34-48.9 ≥49 age; sex; race/ethnicity (Caucasian, African American, His-
panic, or other); household income; socioeconomic status;
n 450 39 136 138 137
primary care giver’s marital status; geographic study region
Age, mean±(SD) 7.4±1.3 7.4±1.2 7.2±1.4 7.2±1.2 7.9±1.3 (urban Boston or rural Maine); blood lead level; fruit and
Sex, n (%) vegetable intake; maternal alcohol/tobacco/drug exposure
Female 240 (53) 22 (56) 72 (53) 77 (56) 69 (50) during pregnancy; and composite restorations (surface
Male 210 (47) 17 (44) 64 (47) 61 (44) 68 (50)
years). Variables were retained in models if they were asso-
No. of carious teeth, 5.3±2.9 6.1±2.9 5.9±3.2 5.1±2.6 4.9±2.6 ciated with the outcome at P<.20 level (see footnotes of
mean±(SD)
Tables 3 to 5 for variables included for each specific out-
No. of carious surfaces, 9.4±6.7 11.9±7.2 10.9±7.8 9.0±6.2 7.5±5.0
mean±(SD)
come). Using cross-product terms in the multivariable
No. of sealed surfaces, 4.0±3.9 0 2.2±2.4 4.5±3.5 6.5±4.3
models, we tested interactions between sealant/PRR treat-
mean±(SD)* ment levels and age, study site (Boston or Maine), or gender
No. children with 15 2 3 6 4 (for psychosocial and neuropsychological outcomes). Results
composite fillings are expressed as beta coefficients indicating the difference
No. of composite 0.1±0.5 0.1±0.5 0.1±0.4 0.1±0.7 0.1±0.5 in test score or growth metric associated with a 10-SY in-
fillings, mean±(SD) crease in sealant/PRR exposure, or adjusted mean value for
Race/ethnicity, n (%)† each SY category, with SD. For menarche, results are ex-
Non-Hispanic 291 (65) 20 (51) 100 (74) 93 (67) 78 (57) pressed as hazard ratio for time to menarche.
Caucasian The complete case analysis for psychosocial and neu-
Non-Hispanic 87 (19) 8 (21) 22 (16) 25 (18) 32 (23) ropsychological measures had 80 percent power at
African American alpha=0.05 to detect a correlation of at least 0.14 between
Hispanic 28 (6) 3 (8) 3 (2) 9 (7) 13 (10) composites exposure level and changes in test scores. For
(nonmixed) physical development outcomes, the analysis had 80 percent
Other 44 (10) 8 (21) 11 (8) 11 (8) 14 (10) power to detect a minimum correlation of 0.20 among
Socioeconomic status, n (%)‡ boys and 0.16 among girls. For analyses of menarche, the
Low 124 (28) 15 (39) 33 (24) 35 (25) 41 (30) subsample of 113 girls achieved 80 percent power to detect
Medium 209 (46) 16 (41) 70 (52) 58 (42) 65 (47) a regression coefficient equal to 0.0149 (hazard ratio=1.015
High 117 (26) 8 (20) 33 (24) 45 (33) 31 (23) for positive associations or 0.985 for inverse associations).
Geographic location, n (%) All analyses were conducted using SAS 9.3 software (SAS
Urban (Boston, Mass.) 230 (51) 21 (54) 53 (39) 77 (56) 79 (58) Institute, Cary, N.C., USA) at alpha=0.05.
Rural (Farmington, 220 (49) 18 (46) 83 (61) 61 (44) 58 (42)
Maine) Results
Drinking water source, n (%)
The mean (±SD) age of study participants was 7.4 (±1.3)
Bottled 119 (30) 4 (31) 33 (26) 35 (27) 47 (37) years at baseline, and most had mixed primary and perma-
Tap 153 (39) 5 (38) 61 (49) 50 (39) 37 (30) nent dentition. Table 1 presents baseline sociodemographic
Mixed 113 (29) 4 (31) 31 (25) 42 (32) 36 (29)
characteristics by category of the total cumulative received
Don’t know 8 (2) 0 (0) 0 (0) 3 (2) 5 (4)
sealant/PRR by the end of the study.
Fruits and vegetables 1.3±0.6 1.3±0.5 1.3±0.7 1.2±0.5 1.3±0.6
During the five-year follow-up, most children received
servings/day, mean±(SD)§ sealants (87 pecent) or PRRs (59 pecent), with 61 pecent
Blood lead level, 2.3±1.8 2.6±2.6 2.2±1.4 2.4±1.7 2.4±2.0 receiving both. Table 2 describes the sealant/PRR treat-
mean±(SD) mg/dL§ ment levels received during the study among all subjects.
Birth weight, 3,340±543 3,152±484 3,415±569 3,327±517 3,329±549 At study entry, 39 (~seven pecent) children had sealants or
mean±(SD) g§ PRRs in place (mean=4.3 surfaces); 37 of these 39 children
Body fat %, mean±(SD) 22.7±10.4 21.5±9.0 20.6±9.2 22.8±10.4 24.8±11.6 had additional sealants or PRRs placed during the study.
Body mass index, 18.0±3.9 17.3±2.9 17.3±3.1 17.9±4.2 18.9±4.2 There were no significant differences in levels of sealant/
mean kg/m2±(SD) PRR treatment by assigned restoration treatment group
Body mass index-by-age 0.6±1.1 0.1±1.2 0.4±1.1 0.6±1.1 0.7±1.1 (composite or amalgam). As expected, there was an inverse
Z-score±(SD) correlation between sealant placement and restoration treat-
ment; children with more sealants placed had fewer restora-
* Sealed with either preventive sealant or preventive resin restoration (PRR). tions during follow-up (Pearson’s correlation coefficient =
† Race/ethnicity was self-reported by the parent of the child. The “other” category included indi-
viduals who identified themselves as Asian, Native American, multiracial (specified), or other
-0.18, P<.001). By contrast, PRR treatment levels were not
(specified). Percentages do not add to 100 because of rounding digits. correlated with restorative fillings (P=.80).
‡ Socioeconomic status index was calculated using household income and education level of the There were no associations between sealant and/or
primary caregiver and standardized to the US population.62 PRR surface years exposure and the primary outcomes of
§ Three children were missing baseline data on marital status of primary caregiver, fruit/vegetable
intake, and gum chewing frequency. Seven children were missing data on baseline blood lead
global behavior scores at the end of follow-up (Table 3).
level. Forty-one children were missing data on birth weight, which was self-reported by the parent. Results were similar in additional analyses (data not shown)

70 DENTAL MATERIALS AND CHILD DEVELOPMENT

 PEDIATRIC DENTISTRY V 36 / NO 1 JAN / FEB 14

examining primary and permanent teeth separately or posterior- Table 2. PLACEMENT OF FLOWABLE COMPOSITES (SEALANTS
occlusal surfaces, excluding children who received composite AND PREVENTIVE RESIN RESTORATIONS [PRR]) AT
restorations or with pre-existing sealants/PRRs. Analyses of THE INITIAL STUDY VISITS AND DURING FIVE-YEAR
scores for specific core syndromes (eg, anxiety, depression, sen- FOLLOW-UP
sation seeking, interpersonal relations) showed similar results
of no consistent associations with sealant or PRR exposure. We No. of sealed surfaces Sealant PRR Total (sealant
and/or PRR)
furthermore examined the cut points of clinically meaningful
scores (normal, at-risk, or clinically significant) and found no Initial study visit, mean±(SD) 3.3±3.6 0.9±1.7 4.2±3.8
consistent or significant associations with sealants/PRR. Lastly, Final year 5 visit (present or 8.0±6.0 2.0±2.6 10.3±6.6
there were no interactions between sealant/PRR exposure and placed at final visit), mean±(SD)
age, study site, or gender. All visits (ever treated), 10.9±8.2 2.7±3.3 13.6±8.9
Neuropsychological test scores over follow-up were not mean±(SD)
associated with tertile of sealant or PRR treatment levels Surface years of exposure by end 29.5±20.5 7.1±10.0 37.7±22.0
(Table 4). Compared to children who ever received any sealants of trial, mean±(SD)
or PRRs, the minority of children receiving no sealants or No. of children ever having the 397 (88) 290 (64) 411 (91)
PRRs during the study (less than six pecent of children) had material placed during the trial, 
distinctly worse five-year changes in WISC-III IQ (eg, mean= n (%)
1.7 point decrease vs. 2.2-3.5 point increase) and WIAT (eg,

Table 3. ASSOCIATION BETWEEN FLOWABLE SEALANTS AND PREVENTIVE RESIN RESTORATIONS (PRRs) AND PSYCHOSOCIAL
FUNCTION GLOBAL SCORES*
  Sealants and PRRs, total surface-years 10 surface-years
    0 Tertile 1 Tertile 2 Tertile 3 Total Sealants PRRs
0.1-33.9 34-48.9 ≥49 Sealant/PRR

Behavior assessment for children year five T-scores, adjusted mean±(SD)

No. of children 18 134 127 129
Surface-years, median 0 20.5 40.5 59.5 βeta±(SD) P-value βeta±(SD) P-value βeta±(SD) P-value
Emotional symptoms 47.8±2.5 49.0±1.6 47.8±1.6 47.3±1.5 -0.4±0.2 .06 -0.3±0.2 .21 -0.5±0.4 .24
index†, mean±(SD)
Clinical maladjustment‡, 47.1±2.7 48.6±1.7 47.1±1.7 46.9±1.7 -0.4±0.2 .09 -0.2±0.2 .38 -0.7±0.4 .11
mean±(SD)
School maladjustment§, 51.7±3.0 54.2±1.9 53.4±1.9 51.9±1.8 -0.3±0.3 .29 -0.2±0.3 .58 -0.5±0.5 .35
mean±(SD)
Personal adjustment║, 49.3±2.5 48.1±1.6 48.5±1.6 49.5±1.5 0.3±0.2 .16 0.2±0.2 .37 0.3±0.4 .40
mean±(SD)

Child Behavior Checklist five-year change scores, adjusted mean±(SD)

No. of children 11 114 111 106
Surface-years, median 0 20.5 40.5 60 βeta±(SD) P-value βeta±(SD) P-value βeta±(SD) P-value
Competence¶, mean±(SD) -3.4±3.7 -0.8±2.4 -2.0±2.4 0.1±2.4 0.2±0.3 .56 0.1±0.3 .71 0.2±0.5 .65
Total problem behaviors #, 3.8±3.5 -2.9±2.3 -1.9±2.3 -2.9±2.3 -0.2±0.3 .57 -0.2±0.3 .50 -0.1±0.5 .84
mean±(SD)
Core syndromes
Withdrawn, mean±(SD) 0.9±1.9 -2.2±1.3 -1.9±1.3 -2.0±1.2 -0.1±0.2 .49 -0.1±0.2 .40 0.1±0.3 .83
Anxious/depressed, -0.1±2.0 -1.8±1.3 -1.5±1.3 -1.9±1.3 -0.1±0.2 .70 -0.2±0.2 .26 0.3±0.3 .23
mean±(SD)
Delinquent behaviors, 0.6±2.2 -1.7±1.4 -1.9±1.4 -1.7±1.4 -0.1±0.2 .60 -0.1±0.2 .45 -0.1±0.3 .76
mean±(SD)

* Multivariable generalized linear models are adjusted for age, sex, race/ethnicity (Caucasian, African American, Hispanic, or other), socioeconomic status (continuous score),
geographic study region (rural or urban), baseline blood lead level, composite restorations (continuous surface years), primary care giver’s marital status (married/living with
partner, separated/divorced/widowed, or single), and maternal alcohol/tobacco/drug exposure during pregnancy (yes/no).
† Emotional symptoms index is a global indicator composed of two scales from clinical maladjustment (anxiety and social stress), two from personal maladjustment (inter-
personal relations and self-esteem), and two from no other domain (depression and sense of inadequacy). Higher scores indicate more problems.
‡ Clinical maladjustment summary score is composed of anxiety, social stress, atypicality, locus of control, and, for ages ≥12 years old, somatization. Higher scores indicate
more problems.
§ School maladjustment summary score is composed of attitude to school, attitude to teachers, and, for ages ≥12 years old, sensation seeking. Higher scores indicate more problems.
║ Personal adjustment summary score is composed of interpersonal relations, relations with parents, self-esteem, and self-reliance. Lower scores indicate more problems.
¶ Competence summary score is composed of activities, social adaptation, and school competence subscales. Lower scores indicate more problems (ie, decreased competence).
These scores do not contribute to the Total Problem Behaviors score from the Child Behavior Checklist.
# Total problem behaviors score is composed of internalizing and externalizing problems scales, as well as four core syndromes: social problems, thought problems, attention
problems, and sex problems. Higher scores indicate more problems on these global and core syndrome scores.

DENTAL MATERIALS AND CHILD DEVELOPMENT 71

PEDIATRIC DENTISTRY V 36 / NO 1 JAN / FEB 14

mean=4.7 point decrease vs. 1.3-1.9 point decrease) yet had a During the five-year study, the prevalence of children
smaller increase in errors on the executive function Wisconsin whose BMI-for-age category was overweight or obese increased
Card Sorting Test (eg, mean total errors=3.8 vs. 17.2-17.8 in- for boys from 35 pecent at baseline to 43 pecent and for girls
crease). Thus, linear tests for trends, including both nonex- from 32 pecent at baseline to 47 pecent. There were no signi-
posed and exposed children, were not appropriate. No statis- ficant associations between sealant/PRR exposure levels and
tically significant associations or trends were observed for test changes in BMI or BF% for girls or boys (Table 5). Among
score changes among those with any sealant/PRR treatment. girls, menarche occurred slightly later with greater exposure
The sensitivity analyses confirmed these findings. to sealants/PRRs (age-adjusted hazard ratio=0.91, 95 percent
confidence interval=0.83-1.01; P=.08).
Table 4. ADJUSTED MEAN±(SD) CHANGES IN NEUROPSYCHOSOCIAL
TEST SCORES BETWEEN BASELINE AND 4- OR 5-YEAR Discussion
FOLLOW-UP, BY TOTAL CUMULATIVE EXPOSURE TO This prospective cohort analysis of children’s exposure to flow-
FLOWABLE SEALANTS AND PREVENTIVE RESIN able composites found no associations between dental sealant
RESTORATIONS (PRRs)* and PRR exposure levels and behavioral, neuropsychological, or
Sealants and PRRs, total surface years category
physical development over the five-year follow-up. To the best
of our knowledge, this is the first analysis of these health out-
Year 5 comes in relation to dental sealant materials in children. Over
5-year change score tests 0 Tertile 1 Tertile 2 Tertile 3 eight million American children have dental sealants, with
0.1-33.9 34.0-48.9 ≥49.0 sealant prevalence increasing across age, race, sex, and poverty
No. of children 23 136 138 137
level subgroups.44 Approximately 10 to 25 pecent of sealants
have been shown to completely fail or have partial retention
Surface years, median 0 21.3 40.5 59.5
within two to three years of placement, although sealant lon-
WISC-III full-scale IQ†, -1.7±2.1 3.5±0.8 2.2±0.8 2.6±0.8
mean±(SD) gevity depends on patient characteristics, sealant material type,
and placement techniques.2,45-48 Laboratory studies have shown
WISC-III factors
that monomers used in sealants are released during place-
Verbal comprehension, -1.0±0.8 0.2±0.3 0.0±0.3 -0.1±0.3
mean±(SD)
ment,49-53 and it is plausible that continued low amounts leach
over time with chemical and mechanical interactions in the
Perceptual organization, -3.4±2.7 3.7±1.0 3.0±0.9 3.2±1.0
mean±(SD) oral environment.7,54 These compounds have been shown to
Freedom from distract- 1.4±3.0 3.9±1.1 1.2±1.0 4.5±1.1
cause various cytotoxic, embryotoxic, genotoxic, and endocrine
ibility, mean±(SD) effects over a range of concentrations in vitro and animal
Processing speed, 0.9±3.4 5.7±1.2 6.2±1.2 6.6±1.2 experiments.9-13,55-57 Thus, a thorough evaluation and assessment
mean±(SD) of the long-term safety of these materials in standard use in pre-
ventive dentistry is important for dental and general public
WIAT† health.
Reading, mean±(SD)  -4.7±2.7 -1.9±1.0 -1.9±1.0 -1.3±1.0
We had previously shown associations of bisGMA-based
Mathematics, -5.3±3.0 -0.7±1.1 -4.0±1.0 -3.2±1.1 dental composite with psychosocial health outcomes in NECAT
mean±(SD) 
Year 4
Table 5. ADJUSTED MEAN±(SD) CHANGES IN BODY MASS
4-year change scores tests 0 Tertile 1 Tertile 2 Tertile 3 INDEX (BMI) Z-SCORE AND BODY FAT PERCENTAGE
0.1-23.9 24.0-35.9 ≥36.0 (BF%) DURING 5-YEAR FOLLOW-UP, BY TOTAL
No. of children  26 127 148 136 CUMULATIVE EXPOSURE TO FLOWABLE SEALANTS
Surface years, median 0 14.5 30.0 44.5 AND PREVENTIVE RESIN RESTORATIONS (PRRs)*
Trail Making Test  Sealants and PRRs, total surface years category
Part B - Part A, -24.7±13.2 -33.4±5.0 -30.7±4.4 -36.8±4.9
mean±(SD)  Males 0 Tertile 1 Tertile 2 Tertile 3
Verbal fluency  0.1-29.9 30.0-45.9 ≥46.0
Letter fluency, 13.5±2.0 13.7±0.8 12.3±0.7 12.9±0.8 No. of males  9 69 61 75
mean±(SD)  Surface years, 0 19.5 39.5 55.0
Stroop Color Word Interference median
Color, mean±(SD)  15.7±3.0 18.2±1.1 19.3±0.9 19.3±0.9 BMI z-score -0.02±0.23 0.08±0.1 -0.17±0.1 -0.04±0.09
Color Word, mean±(SD) 13.9±2.4 13.8±0.9 12.5±0.7 13.6±0.8 BF% 6.21±2.84 3.82±1.21 3.70±1.23 3.94±1.12
Females 0 0.1-23.9 24-35.9 ≥36
Wisconsin Card Sorting Test
No. of categories 0.8±0.4 1.1±0.2 1.1±0.1 1.1±0.1 No. of females 13 77 83 78
achieved, mean±(SD) Surface years, 0 15.0 39.0 60.5
Total perseverative 7.9±4.0 19.0±1.6 20.3±1.4 20.4±1.6 median
errors, mean±(SD) BMI z-score 0.17±0.18 0.25±0.08 0.30±0.07 0.24±0.08
Total errors, mean±(SD) 3.8±4.1 17.2±1.6 17.8±1.4 17.6±1.6 BF% 6.43±2.23 8.40±0.96 7.69±0.88 7.50±0.96

*No statistically significant associations (P>.05) between sealant/preventive resin restoration
exposure and neuropsychological test score changes among children in tertiles 1-3. Means
are adjusted for age, sex, socioeconomic status (continuous score), geographic study region
(urban or rural), baseline blood lead level, and composite restorations (surface years).
†WISC-III: Wechsler Intelligence Scale for Children-Third Edition; WIAT: Wechsler
Individual Achievement Test.
* No statistically significant associations (P>.05) between sealant/preventive resin re-
storation exposure and body mass or body fat changes. Table 5 presents multivariable-
adjusted mean changes over follow-up. All models were adjusted for age and either
baseline BMI z-score (for BMI models) or height and baseline body fat percentage
(for body fat models). For boys, models additionally were adjusted for household in-
come (<$20,000, $20,000-$40,000, or >$40,000) and race/ethnicity. For girls, models
were additionally adjusted for daily servings of fruits and vegetables.

72 DENTAL MATERIALS AND CHILD DEVELOPMENT


participants. In the current analysis of bisGMA-based sealants,
most estimates, except for menarche,32 were in the opposite
direction of estimates for composite.31,33 Although this may be
an artifact of the inverse correlation between composites and
sealants, the correlation between sealants and composite was
relatively small. It is possible that nondental factors contri-
buted, such as residual confounding by unmeasured socioeco-
nomic factors or oral health attitudes related to having sealant
placement. However, without relevant biomarker data, it is
difficult to explain the lack of similar findings between com-
posite and sealant materials. In other words, it is possible that
the different results for the composite and the sealant were
due to differences in material manufacturing, including the
precise monomers and other components used and/or the
resulting integrity (ie, degradation) of the materials once in the
mouth and exposed to the oral environment.
Flowable composites have higher resin content and in gen-
eral, inferior mechanical properties, compared to standard
hybrid composites.58 However, standard nonflowable compo-
sites that are placed in bulk and undergo bulk polymerization
could be subject to less complete curing59 and, hence, more ex-
posure to resin monomers. Previous studies of leaching from
dental material components have shown increased saliva levels
of BPA and related compounds within a few hours after treat-
ment, but the extent of leaching over time as materials degrade
is unknown.23,27 If negligible leaching occurred after the initial
exposure during placement, this might be a reason for the lack
of association with the outcomes measured in this study. Thus,
a limitation of NECAT for these secondary data analysis was
that urinary concentrations of BPA, bisGMA, TEGDMA,
HEMA, or other compounds that may leach from sealants were
not measured. Biomarker data would help elucidate whether
differences in results were due to differences in the internal dose
of chemical exposures or to artifacts of unknown or unmeasured
factors associated with dental treatment. Additional studies
that include biomarker measurement along with prospective
longitudinal data on dental treatment and health outcomes are
needed for a comprehensive examination of the long-term safety
of dental materials.
For this secondary data analysis, we combined data on two
different materials used for sealants and PRRs, to evaluate total
flowable composites exposure. Although both materials contain
bisGMA, differences in mechanical properties could lead to
differences in leaching of components. Considering that this
study was not designed to investigate sealant materials, we
conducted numerous sensitivity analyses to assess the robustness
of the findings (eg, excluding subgroups of children, such as
those with pre-existing sealants and those not receiving any
sealants) and examine strata of age, sex, or race.
The results consistently showed no associations with these
psychosocial, neuropsychological, or growth outcomes. The
minority of children who did not receive sealants had, on aver-
age, worse change compared to children who followed routine
study procedures to receive any sealants. This difference may
be due to the small sample size of children without sealants or
to unmeasured factors related to not receiving sealants. For this
reason, we focused our interpretation of results on categories
of sealant exposure, particularly among those ever treated (ie,
tertiles of exposure). Overall, these results showed no effects
from sealants and furthermore confirmed the caries prevention
benefits of sealant placement.
While sealant level was not significantly associated statistic-
ally with age of menarche, the direction indicating later me-
PEDIATRIC DENTISTRY V 36 / NO 1 JAN / FEB 14
narche was consistent with our previous findings for random-
ization to composite restoration treatment.32 In animal experi-
ments, BPA alters reproductive development, often accelerating
onset of puberty, and also causes altered reproductive param-
eters, such as number of estrous cycles and days of estrus60 and
impaired follicle formation.61 Our analysis raises the question
of a possible effect on later age of menarche, although it is not
sufficient to draw any conclusions. The menarche analyses were
exploratory due to limitations in the sample (ie, a subset of
girls from one study site) and follow-up age window, in that
not all girls had reached menarche within the five-year study
period. Furthermore, although children randomized to com-
posite restorations had later menarche compared to those
randomized to amalgam, there was no association between
composite restoration treatment levels and age of menarche.32
Strengths of the study include that the data were obtained
as part of a randomized clinical trial. The dental procedures,
including materials used and placement procedures, and the
treatment levels were strictly monitored for the trial. In addi-
tion, health assessments for the outcomes analyzed here were
conducted using validated and routinely calibrated measures.
This analysis was well-powered to detect associations between
sealants and the health outcome measures. Given the eligibil-
ity criteria of two or more caries, the trial did not include a US
population-based representative sample of children; however,
its focus on children in need of dental treatment resulted in a
sample of children who represent the specific targets of sealant
programs (ie, children at high risk of caries).
In summary, this analysis does not provide evidence to alter
current practice regarding dental sealants. It remains uncertain
whether the association between composite restorations and
adverse psychosocial outcomes was caused by: higher long-term
release of compounds from restorative composite compared to
preventive sealants; the particular combination of compounds
in the composite; or some unknown confounding factor or
chance difference between composite and amalgam treatment
groups in the clinical trial. Future research should include bio-
marker measures along with treatment and longitudinal health
outcomes data.
Conclusions
Based on this study’s results, the following conclusions can be
made:
1. Cumulative treatment levels of bisGMA-containing
dental sealants and preventive resin restorations were
not associated with psychosocial health or behavior
problems in children or adolescents after the five-
year follow-up.
2. Cumulative treatment levels of bisGMA-containing
dental sealants and PRRs were not associated with
changes in neuropsychological test scores, body
composition, or body mass index during the five-year
study.
3. No evidence was provided to suggest alterations to
standard procedures and materials used for preventive
dental sealants or PRRs in children.
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