Absence of Fluoride Varnish-Related Adverse Events in Caries Prevention Trials in Young Children, United States.

INTRODUCTION: Fluoride varnish is an effective prevention intervention for caries in young children. Its routine use in clinical care is supported by meta-analyses and recommended by clinical guidelines, including the US Preventive Services Task Force (B rating). This report is the first prospective systematic assessment of adverse events related to fluoride varnish treatment in young children. METHODS: We determined the incidence of adverse events related to fluoride varnish treatment in 3 clinical trials on the prevention of early childhood caries, conducted under the auspices of the Early Childhood Caries Collaborating Centers, an initiative sponsored by the National Institute of Dental and Craniofacial Research. Each trial incorporated use of fluoride varnish in its protocol and systematically queried all children's parents or legal guardians about the occurrence of acute adverse events after each fluoride varnish treatment. RESULTS: A total of 2,424 community-dwelling, dentate children aged 0 to 5 years were enrolled and followed for up to 3 years. These children received a cumulative total of 10,249 fluoride varnish treatments. On average, each child received 4.2 fluoride varnish treatments. We found zero fluoride varnish-related adverse events. CONCLUSION: Fluoride varnish was not associated with treatment-related adverse events in young children. Our findings support its safety as an effective prevention intervention for caries in young children.

Developing an acceptability assessment of preventive dental treatments.

OBJECTIVES: Early childhood caries (ECC) is very prevalent among young Hispanic children. ECC is amenable to a variety of preventive procedures, yet many Hispanic families underutilize dental services. Acceptability research may assist in health care planning and resource allocation by identifying patient preferences among efficacious treatments with the goal of improving their utilization. The purposes of this study were (a) to develop a culturally competent acceptability assessment instrument, directed toward the caregivers of young Hispanic children, for five preventive dental treatments for ECC and (b) to test the instrument's reliability and validity. METHODS: An instrument of five standard treatments known to prevent ECC was developed, translated, reviewed by focus groups, and pilot tested, then tested for reliability The instrument included illustrated cards, brief video clips, and samples of the treatments and was culturally appropriate for low-income Hispanic caregivers. In addition to determining the acceptability of the five treatments individually, the treatments were also presented as paired comparisons. RESULTS: Focus groups and debriefing interviews following the pilot tests established that the instrument has good face validity. The illustrated cards, product samples, and video demonstrations of the five treatments resulted in an instrument possessing good content validity. The instrument has good to excellent test-retest reliability, with identical time 1-time 2 responses for each of the five treatments 92 percent of the time (range 87 to 97 percent), and the same treatment of the paired comparisons preferred 75 percent of the time (range 61 to 90 percent). CONCLUSIONS: The acceptability instrument described is reliable and valid and may be useful in program planning efforts to identify and increase the utilization of preferred ECC preventive treatments for target populations.

Methods and software for estimating health disparities: the case of children's oral health.

The National Center for Health Statistics recently issued a monograph with 11 guidelines for reporting health disparities. However, guidelines on confidence intervals (CIs) cannot be readily implemented with the complex sample surveys often used for disease surveillance. In the United States, dental caries (decay) is the most common chronic childhood disease-5 times more common than asthma. Racial/ethnic minorities, immigrants, and persons of lower socioeconomic position (SEP) have a greater prevalence of caries. The authors provide methods for applying National Center for Health Statistics guidelines to complex sample surveys (health disparity indices and absolute and relative difference measures assessing associations of race/ethnicity and SEP to health outcomes with CIs); illustrate the application of those methods to children's untreated caries; provide relevant software; and report results from a simulation varying prevalence. They use data on untreated caries from the California Oral Health Needs Assessment of Children 2004-2005 and school percentage of participation in free/reduced-price lunch programs to illustrate the methods. Absolute and relative measures, the Slope Index of Inequality, the Relative Index of Inequality (mean and ratio), and the Health Concentration Index were estimated. Taylor series linearization and rescaling bootstrap methods were used to estimate CIs. Oral health differed significantly between White children and all non-White children and was significantly related to SEP.

Mediation analysis for count and zero-inflated count data.

Different conventional and causal approaches have been proposed for mediation analysis to better understand the mechanism of a treatment. Count and zero-inflated count data occur in biomedicine, economics, and social sciences. This paper considers mediation analysis for count and zero-inflated count data under the potential outcome framework with nonlinear models. When there are post-treatment confounders which are independent of, or affected by, the treatment, we first define the direct, indirect, and total effects of our interest and then discuss various conditions under which the effects of interest can be identified. Proofs are provided for the sensitivity analysis proposed in the paper. Simulation studies show that the methods work well. We apply the methods to the Detroit Dental Health Project's Motivational Interviewing DVD trial for the direct and indirect effects of motivational interviewing on count and zero-inflated count dental caries outcomes.

Caregiver acceptability and preferences for preventive dental treatments for young African-American children.

UNLABELLED: Our prior research focused on parental treatment acceptability (TA) and treatment preferences (TPs) for preventive dental treatments for young Hispanic children. We adapted the interview for administration to parents of young African-American children. OBJECTIVE: In a sample of African-American parents, determine parental TA and TP for five dental treatments to prevent early childhood caries. METHODS: Interviewed 48 parents/caregivers of African-American children attending Head Start, assessing TA and TP for three treatments for children: toothbrushing (TB) with fluoride toothpaste, fluoride varnish (FV), and xylitol in food (XF); and two treatments for mothers: xylitol gum (XG) and chlorhexidine (CHX) rinse. The interview included verbal information, illustrated treatment cards, photos/video clips, and samples. Parents provided TA of each treatment (one to five scale), TP between each of 10 pairs of the five treatments, and open-ended reasons for their preferences. TPs were summed (zero to four) to create overall preference. RESULTS: All treatments were acceptable (means 4.4-4.9). TB was more acceptable than FV and XF (P < 0.05). Summed TP revealed a strong preference for TB (mean 3.1) above other treatments (all P < 0.01). Primary reasons for preferring TB were the following: promotes healthy habits; child focused; and effectiveness. CONCLUSIONS: All treatments were acceptable, however, parents/guardians strongly preferred TB. Parents' emphasis on healthy habits and child-focused treatment supports efforts for oral health education programs in early childhood settings. Some parents expressed concerns about FV, XF, and CHX. Results may be useful in planning prevention programs for young children in African-American communities.

Functional remineralization of dentin lesions using polymer-induced liquid-precursor process.

It was hypothesized that applying the polymer-induced liquid-precursor (PILP) system to artificial lesions would result in time-dependent functional remineralization of carious dentin lesions that restores the mechanical properties of demineralized dentin matrix. 140 µm deep artificial caries lesions were remineralized via the PILP process for 7-28 days at 37°C to determine temporal remineralization characteristics. Poly-L-aspartic acid (27 KDa) was used as the polymeric process-directing agent and was added to the remineralization solution at a calcium-to-phosphate ratio of 2.14 (mol/mol). Nanomechanical properties of hydrated artificial lesions had a low reduced elastic modulus (E(R) = 0.2 GPa) region extending about 70 µm into the lesion, with a sloped region to about 140 µm where values reached normal dentin (18-20 GPa). After 7 days specimens recovered mechanical properties in the sloped region by 51% compared to the artificial lesion. Between 7-14 days, recovery of the outer portion of the lesion continued to a level of about 10 GPa with 74% improvement. 28 days of PILP mineralization resulted in 91% improvement of E(R) compared to the artificial lesion. These differences were statistically significant as determined from change-point diagrams. Mineral profiles determined by micro x-ray computed tomography were shallower than those determined by nanoindentation, and showed similar changes over time, but full mineral recovery occurred after 14 days in both the outer and sloped portions of the lesion. Scanning electron microscopy and energy dispersive x-ray analysis showed similar morphologies that were distinct from normal dentin with a clear line of demarcation between the outer and sloped portions of the lesion. Transmission electron microscopy and selected area electron diffraction showed that the starting lesions contained some residual mineral in the outer portions, which exhibited poor crystallinity. During remineralization, intrafibrillar mineral increased and crystallinity improved with intrafibrillar mineral exhibiting the orientation found in normal dentin or bone.

Language and literacy relate to lack of children's dental sealant use.

OBJECTIVES: This study aimed to determine the percent of California's third grade public school children lacking sealants by child and family factors and to measure social disparities for lacking sealants. METHODS: The study analyzed data from the California Oral Health Needs Assessment (COHNA) 2004-2005, a complex stratified cluster sample of children (n = 10,450) from 182 randomly selected public elementary schools in California. The dependent variable was absence of sealants in first permanent molars. The independent variables included child race/ethnicity; socio-economic position (SEP) measured as child's participation in the free or reduced-price lunch program at the individual and school level; acculturation measured as language spoken at home and school level percent of English language learners; and parent functional health literacy measured as correctly following questionnaire instructions. Absolute differences and health disparity indices (i.e. Slope Index of Inequality, Relative Index of Inequality-mean, Absolute Concentration Index) were used to measure absolute and relative disparities. RESULTS: The percent of children lacking sealants was high in all racial/ethnic groups; no child or school level SEP differences in lacking sealants were seen, but significant differences existed by acculturation (child and school level) and parental functional health literacy. CONCLUSIONS: NonEnglish language and poor parental functional health literacy are potential barriers that need to be addressed to overcome disparities in sealant utilization.