Addition of Povidone-Iodine to Fluoride Varnish for Dental Caries: A Randomized Clinical Trial.

INTRODUCTION: Dental caries is the most common chronic childhood disease. Products of metabolism by bacteria populating the tooth surface induce development and progression of cavities. OBJECTIVES: We sought to determine whether a polyvinylpyrrolidone-iodine (PVP-I; povidone-iodine) and NaF topical varnish was superior to one containing only NaF in prevention of new dental caries lesions in a single-center randomized active-controlled trial based on a double-blind, parallel-group design. METHODS: The site was Pohnpei State, Federated States of Micronesia. The study population was healthy children 49 to 84 mo old who were enrolled in early childhood education: 284 were randomized (1:1 allocation), and 273 were included in year 1 analysis and 262 in year 2. The test varnish contained 10% PVP-I and 5.0% NaF. The comparator contained only 5.0% NaF but was otherwise identical. Varnishes were applied every 3 mo during 2 y. The primary outcome was the surface-level primary molar caries lesion increment (d2-4mfs) at 2 y. Caries lesion increments from baseline to year 1 and year 2 were compared between conditions with log-linear regression, adjusting for age and sex and whether the tooth was sound at baseline (free of caries lesions). RESULTS: At year 1, the caries lesion increment for primary molars sound at baseline was 0.9 surfaces (SD = 1.5) for the test varnish versus 1.8 (SD = 2.2) for the comparator varnish with fluoride alone (adjusted rate ratio, 0.50; 95% CI, 0.31 to 0.81; P = .005). At year 2, the caries lesion increment for primary molars sound at baseline was 2.3 surfaces (SD = 2.8) for the test varnish as compared with 3.3 (SD = 2.7) for the comparator (adjusted rate ratio, 0.74; 95% CI, 0.52 to 1.03; P = .073). Teeth that were already cavitated at baseline did not show a preventive effect. There were no harms. CONCLUSIONS: A dental varnish containing PVP-I and NaF is effective in the primary prevention of cavities in the primary dentition (NCT03082196). KNOWLEDGE TRANSFER STATEMENT: This study demonstrates that periodic application of a varnish containing NaF and PVP-I is effective in prevention of caries lesions and useful in assessing the potential of combined treatment.

Silver Diamine Fluoride in Children Using Physiologically Based PK Modeling.

Silver diamine fluoride (SDF) is used topically to prevent or arrest dental caries and has been tested clinically in toddlers to elderly adults. Following SDF application, small quantities of silver can be swallowed and absorbed. To monitor silver concentrations, pharmacokinetic studies can be performed. However, pharmacokinetic studies are time-consuming, resource intensive, and challenging to perform in young children. The objective of this study was to develop a physiologically based pharmacokinetic (PBPK) model to predict silver disposition in children. The PBPK model for silver was developed using Simcyp software (version 17.0) based on information obtained from literature sources. The predictive performance of the model was assessed by comparing the predicted PK profiles and parameters with the observed data from published rat and human data following intravenous or oral silver administration. The predicted silver concentrations were within 2-fold of observed blood and tissue silver concentrations in rats and within the 95% confidence interval of observed plasma silver concentrations in healthy human adults. The PBPK model was applied to the pediatric population by accounting for developmental physiological changes. For a given SDF dose, the simulated peak silver concentrations were 5.2-, 4.3-, 2.7-, and 1.3-fold higher in children aged 1 to 2, 2 to 4, 5 to 10, and 12 to 17 y, respectively, compared to adults. As silver is reportedly excreted in the bile, the half-life of silver was comparable in all ages and plasma and tissue silver concentrations were predicted to return to baseline levels within 2 wk after SDF application. The simulation in children suggests that conventional SDF application to teeth to prevent or arrest dental caries results in plasma and tissue silver concentrations lower than toxic concentrations. PBPK modeling offers a novel approach to studying dental exposures in younger children, where pharmacokinetic studies would be difficult to conduct.

Organizational Readiness to Implement System Changes in an Alaskan Tribal Dental Care Organization.

INTRODUCTION: Tribal health care systems are striving to implement internal changes to improve dental care access and delivery and reduce health inequities for American Indian and Alaska Native children. Within similar systems, organizational readiness to implement change has been associated with adoption of system-level changes and affected by organizational factors, including culture, resources, and structure. OBJECTIVES: The objectives of this study were to assess organizational readiness to implement changes related to delivery of evidence-based dental care within a tribal health care organization and determine workforce- and perceived work environment-related factors associated with readiness. METHODS: A 92-item questionnaire was completed online by 78 employees, including dental providers, dental assistants, and support staff (88% response rate). The questionnaire queried readiness for implementation (Organizational Readiness for Implementing Change), organizational context and resources, workforce issues, organizational functioning, and demographics. RESULTS: Average scores for the change commitment and change efficacy domains (readiness for implementation) were 3.93 (SD = .75) and 3.85 (SD = .80), respectively, where the maximum best score was 5. Perceived quality of management, a facet of organizational functioning, was the only significant predictor of readiness to implement change (B = .727, SE = .181, P < .0002) when all other variables were accounted for. CONCLUSION: Results suggest that when staff members (including dentists, dental therapists, hygienists, assistants, and support staff) from a tribal health care organization perceive management to be high quality, they are more supportive of organizational changes that promote evidence-based practices. Readiness-for-change scores indicate an organization capable of institutional adoption of new policies and procedures. In this case, use of more effective management strategies may be one of the changes most critical for enhancing institutional behaviors to improve population health and reduce health inequities. KNOWLEDGE TRANSFER STATEMENT: The results of this study can be used by clinicians and other leaders implementing changes within dental care organizations. To promote organizational readiness for change and, ultimately, more expedient and efficient adoption of system-level changes by stakeholders, consideration should be given to organizational functioning generally and quality of management practices specifically.

Randomized Trial Based on the Common-Sense Model of Self-regulation to Increase Child Dental Visits.

INTRODUCTION: School screening and the note home (pinned to a backpack) informing parents/caregivers that their child needs to see a dentist have not been effective. OBJECTIVES: The Family Access to a Dentist Study (FADS) evaluated the effectiveness of school interventions based on the common-sense model of self-regulation (CSM) among K-4 children needing restorative treatment. METHODS: FADS was a multisite double-blind randomized controlled trial with 5 arms. FADS tested a CSM-driven referral letter and dental information guide (DIG) to move caregivers from inaccurate to accurate perceptions of dental caries. Six school districts from Ohio and Washington (14 schools) participated in school years 2015 to 2016 and 2016 to 2017. A total of 611 caregivers were randomized, and 86% (n = 597 children) completed the exit examination. The primary outcome was receipt of care based on a change in oral health status determined clinically within 1 school year. RESULTS: In accordance with our primary aims, 5 arms were collapsed into 3: CSM letter and reduced CSM letter (combined), CSM letter + DIG and reduced CSM letter + reduced DIG (combined), and standard letter. Among all sites, 39.7% received restorative care (237 of 597). Combined analysis of sites revealed that the CSM referral letter (with and without the DIG) did not increase dental visits when compared with the standard letter. However, for combined sites (East Cleveland, Ohio; Washington), the CSM + DIG increased dental visits when compared with standard letter in univariate analysis (51.3% vs. 40.9%), indicating 1.6-times increased odds of a dental visit (95% CI, 0.97 to 2.58) after imputation and adjustment for covariates. The CSM + DIG group had 1.9-times increased odds (95% CI, 1.21 to 3.08) of care when compared the CSM letter alone. CONCLUSION: A CSM-driven approach to informing caregivers of the chronic nature of caries with resources in an illustrative manner can increase the benefit of school oral health screening (ClinicalTrials.gov NCT02395120). KNOWLEDGE TRANSFER STATEMENT: A school dental referral (note home) that tells a parent that the child has cavities has not been effective. In this trial, a referral based on the common-sense model of self-regulation increased follow-up care for children with restorative needs.

Pharmacokinetics of Iodine and Fluoride following Application of an Anticaries Varnish in Adults.

Researchers have suggested that combining topical fluoride with an antiseptic to reduce cariogenic bacteria may be more effective than fluoride application alone in preventing dental caries. In previous studies, povidone iodine (PVP-I), a widely used bactericidal antiseptic, and sodium fluoride (NaF), used to foster remineralization of enamel, were applied sequentially topically and shown to be safe and effective. The study aim was to characterize the kinetics of iodine and fluoride following topical application of a single combination PVP-I and NaF anticaries varnish in healthy adults. Sixteen participants (aged 23 to 57 y) participated in a pharmacokinetics study following the application of 0.4 mL varnish containing 10% (w/v) PVP-I and 5% (w/v) NaF. Serum and urine samples were collected at various time points over 24 h following application of varnish. Iodine and fluoride concentrations were analyzed, and for each time point, baseline concentrations were subtracted from observed values. Following varnish application, 2 of 16 participants had nearly undetectable baseline-corrected iodine and fluoride levels, suggesting minimal absorption, lack of release of iodine and fluoride from the varnish, or inconsistent dosing. The average peak concentrations were 57 ± 33 ng/mL iodine and 60 ± 34 ng/mL (0.060 ± 0.034 ppm) fluoride and occurred within 3 h of application. The average elimination half-life was 5.5 ± 1.4 h and 3.1 ± 1.6 h for iodine and fluoride, respectively. Renal clearance of iodine and fluoride was similar to literature values. No adverse events related to the study varnish were observed by the investigative team or reported by the participants. In this study, serum fluoride and iodine transiently increased but were within normal range 24 h after application of the varnish. This study has shown that the combination of PVP-I and NaF in a proposed anticaries varnish was well tolerated. Knowledge Transfer Statement: This clinical study demonstrated that a dental varnish combining 10% (w/v) povidone iodine and 5% (w/v) sodium fluoride is well tolerated. Serum fluoride and iodine transiently increased but were within normal range after 24 h. Further studies should be conducted to assess the efficacy of a combination in preventing dental caries, especially in high-risk populations.

Evaluation of a parent-designed programme to support tooth brushing of infants and young children.

OBJECTIVES: This study developed and tested an intervention to help parents establish a routine of brushing their young children's teeth twice a day. METHODS: Community-based participatory research methods were used to engage parents in the design of the intervention to maximize its relevance and acceptability to others. Input was obtained by interviews and focus groups. The resulting intervention was four 90-min small-group sessions that provided educational information, direct instruction, practice and peer-to-peer problem-solving. A pre- to post-non-randomized design was used to evaluate the intervention's effect to increase or maintain parents' twice daily brushing. RESULTS: Intervention participants were 67 primary caregivers of children under six years of age. Of the 67 initial participants, 50 completed a post-intervention questionnaire administered 4 to 8 weeks following the intervention. The proportion of parents who reported brushing their young children's teeth twice a day increased significantly from 59 per cent prior to the intervention to 89 per cent post-intervention (McNemar's X(2)  = 10.71, P = 0.002). There were concomitant and statistically significant increases over the study period in parents' confidence for brushing twice a day, attitudes about the importance of brushing and their self-efficacy for tooth brushing. Parents' knowledge of children's oral health, assessed by a 15-item scale developed for this study ('Things to Know About Baby Teeth'), also increased significantly. CONCLUSIONS: Twice daily tooth brushing is a low-cost, effective strategy to reduce the risk of childhood caries. As demonstrated here, community-based efforts can help parents achieve this important health behaviour.

Improving children's oral health: an interdisciplinary research framework.

Despite the concerted efforts of research and professional and advocacy stakeholders, recent evidence suggests that improvements in the oral health of young children in the United States has not followed the prevailing trend of oral health improvement in other age groups. In fact, oral health disparities in the youngest children may be widening, yet efforts to translate advances in science and technology into meaningful improvements in populations' health have had limited success. Nevertheless, the great strides in genomics, biological, behavioral, social, and health services research in the past decade have strengthened the evidence base available to support initiatives and translational efforts. Concerted actions to accelerate this translation and implementation process are warranted; at the same time, policies that can help tackle the upstream determinants of oral health disparities are imperative. This article summarizes the proceedings from the symposium on the interdisciplinary continuum of pediatric oral health that was held during the 43rd annual meeting of the American Association for Dental Research, Charlotte, North Carolina, USA. This report showcases the latest contributions across the interdisciplinary continuum of pediatric oral health research and provides insights into future research priorities and necessary intersectoral synergies. Issues are discussed as related to the overwhelming dominance of social determinants on oral disease and the difficulty of translating science into action.

Implementation partnerships in a community-based intergenerational oral health study.

BACKGROUND: University-community partnerships are a common strategy used in implementing community-based health promotion trials, yet few published studies report these interactions in detail. "Baby Smiles" was a five-year intervention study in Oregon, USA. The study involved 400 low-income women during and after pregnancy across four rural counties. In this report, we describe and assess four university-community health partnerships formed to support the intervention. METHODS: A community health partnership advisory group for the study was established in each of the four participating counties. Group membership ranged from 9 to 23 individuals. A survey was administered to the groups five times in a 2.5 year period. The survey asked members' opinions of the intervention's goals, scientific basis and relevance to their organisation. Questions also asked about members' knowledge of oral health, beliefs about access to dental care for low-income pregnant women and children in their county and how their organisation functioned. RESULTS: There was strong overall support by each partnership group despite differences in the groups' structure, foci and turnover in membership during intervention period. Responses to specific survey items indicating misinformation or negative opinions about oral health care were used to address weaknesses in study implementation throughout the conduct of the study. CONCLUSION: Systematic monitoring of community support for a multi-year oral health intervention is feasible and can identify potential barriers to address while the study is underway.

Increased enamel hypoplasia and very low birthweight infants.

Birth cohort studies of developmental defects of enamel (DDE) and early childhood caries (ECC) in very low birthweight (VLBW) and normal birthweight (NBW) infants are rare. In this birth cohort of 234 VLBW and 234 NBW infants, we report the incidence of ECC and DDE at 8 and 18-20 mos of corrected age. Infant medical and maternal socio-demographic data were abstracted from medical records at birth. Dental assessments for ECC and DDE (enamel hypoplasia, demarcated and diffuse opacities) were completed at 8 and 18-20 mos. The incidence of hypoplasia was significantly higher in VLBW compared with NBW infants (8 mos, 19% vs. 2%; 18 mos, 31% vs. 8%). The incidence of ECC (International Caries Detection and Assessment System: ICDAS ≥ 2) was 1.4% (8 mos) and 12% (18-20 mos) and was similar between the VLBW and NBW groups. At both ages, using a beta-binomial regression model to control for potential confounders (maternal and infant characteristics), we found increased risk for enamel hypoplasia among the VLBW infants compared with the NBW infants. African Americans had a lower risk for enamel hypoplasia at 18-20 mos. The VLBW infants should be monitored for ECC due to the presence of enamel hypoplasia.

A first look: determinants of dental care for children in foster care.

PURPOSE: This hypothesis-generating study sought to identify potential determinants of dental care use and oral health among children living in foster care. METHOD: Using a grounded theory approach, fourteen key informant interviews were conducted among health and social services professionals experienced with children in foster care and families in western Washington State. RESULTS: The identified potential determinants of oral health and dental use among children living in foster care included: (1) linguistic and cultural barriers; (2) lack of dentists willing to accept children's Medicaid dental insurance; (3) lack of resources available to case workers (i.e., large caseload burden) (4) lack of federal funding for specialized dental care; (5) lack of systematic health record-keeping; (6) child transience, leading to the lack of a dental home; (8) foster parents' competing needs; (7) child behavior problems; and (9) lack of dental "buy in" from adolescents. CONCLUSION: Additional studies are needed to determine whether children living in foster care achieve oral health, and the extent of their unmet dental need.

Xylitol carryover effects on salivary mutans streptococci after 13 months of chewing xylitol gum.

To assess mutans streptococci (MS) during xylitol gum chewing (mean 3.8 g/day, 2.9 times/day) for 13 months and then for 15 months after the intervention, Japanese mothers with high salivary MS were randomized into two groups: xylitol gum (n = 56) and no gum (n = 51). The proportion of low MS levels was highest at 3 months of consumption (48.8%), but was significantly lower compared to baseline at the end of the intervention (p < 0.001). MS levels did not change during the postintervention period. The data suggest that in the xylitol group 23.3% showed persistent carryover effects by xylitol gum chewing in the postintervention period.

Clinical evidence for polyol efficacy.

Xylitol is a safe dental caries preventive when incorporated into chewing gum or confections used habitually. The goal of this paper is to identify and assess the work on xylitol and other polyols and dental caries since 2008. Xylitol is effective when used by the mother prenatally or after delivery to prevent mutans transmission and subsequent dental caries in the offspring. One new completed trial confirmed that children of mothers who used xylitol lozenges after delivery had less dental caries than a comparison group. A similar study confirmed that the use of xylitol gum by the mother either prevented or postponed MS transmission to the offspring. Xylitol use among schoolchildren delivered via a gummy bear confection reduced S. mutans levels, but a once per day use of xylitol-containing toothpaste did not. Randomized trials, with caries outcomes, assessing xylitol-containing lozenges in adults and xylitol-containing gummy bears in children will release results in the coming year. Other studies are ongoing but are not systematic and will fail to answer important questions about how xylitol, or other polyols, can address the global dental caries problem.

The short-term effects of diammine silver fluoride on tooth sensitivity: a randomized controlled trial.

Tooth sensitivity is a common clinical problem. This multi-center randomized clinical trial assessed the effectiveness and safety of topical diammine silver fluoride. From two sites (Lima and Cusco, Peru), 126 adults with at least one tooth sensitive to compressed air were randomly assigned to either the experimental treatment or sterile water, and pain was assessed by means of a 100-mm visual analogue scale at 24 hours and 7 days. The diammine silver fluoride reduced pain at 7 days at both sites. At the Lima site, the average change in pain scores between baseline and day 7 for the silver fluoride group was -35.8 (SD = 27.7) mm vs. 0.4 (SD = 16.2) mm for the control group (P < 0.001). In Cusco, the average change in pain scores for the silver fluoride group was -23.4 (SD = 21.0) mm and -5.5 (18.1) mm for the control group (P = 0.002). No tissue ulceration, white changes, or argyria was observed. A small number of participants in the silver fluoride group experienced a mild but transient increase in erythema in the gingiva near the tooth. No changes were observed in the Gingival Index. We concluded that diammine silver fluoride is a clinically effective and safe tooth desensitizer.

What happens after referral for sedation?

OBJECTIVE: To follow up 100 referrals to the sedation clinic, examining dental anxiety and background of patients, and to assess how many patients attended for treatment planning, initial treatment and how many completed treatment, and describe the characteristics of each. For those who attended for initial treatment, to investigate which type of sedation they received and the level of clinician they saw. DESIGN: Descriptive, cross-sectional survey and review of case notes. SUBJECTS AND METHODS: Subjects were 100 consecutive new patients to the Department of Sedation and Special Care Dentistry at Guy's and St Thomas NHS Foundation Trust. The notes were analysed by an experienced member of staff (CAB) and data entered into an Excel spreadsheet and an SPSS data file created. These data were merged with a dataset containing their responses to the initial questionnaire and medical history for analysis. RESULTS: Of the 100 patients initially referred, 72 attended the treatment planning session, 66 of the 72 (92%) attended for initial dental treatment, and 33 of 66 (50%) completed treatment. Dental Fear Survey (DFS) scores were related to attendance at the initial treatment visit but not to completion of treatment. Only 33 of 100 referred patients completed treatment. CONCLUSIONS: Attendance for treatment planning and initial treatment was high. Attendance is related to fear and mental health. Overall completion of treatment from referral was 33%.

Randomized equivalence trial of intensive and semiannual applications of fluoride varnish in the primary dentition.

For children in the primary dentition with high caries prevalence the standard semiannual application of fluoride varnish may not be successful in preventing tooth decay. Oftentimes this population is mobile and does not receive consistent preventive care. This trial tested whether an intensive fluoride 5% sodium varnish regimen (three applications/2 weeks) applied annually has an equivalent effect on caries progression in the primary dentition compared to single applications applied semiannually. This study was a randomized clinical trial with two treatment groups. All participants (n = 600; mean age +/- SD = 55.3 +/- 4.6 months) received three varnish applications (active varnish or placebo) at semiannual visits over 3 years. Once per year the intensive-treatment group received one set of three active treatments and three placebo treatments 6 months later, each time within 2 weeks. The standard group received one active and two placebo treatments every 6 months. Children were assessed clinically at baseline and 12, 24 and 36 months after the initiation of the study. The mean (SD) numbers of newly decayed primary tooth surfaces observed over 3 years were 9.8 (8.6) and 7.4 (7.7) in the intensive and standard groups, respectively. The adjusted rate ratio was 1.13 (95% CI = 0.94-1.37, p = 0.20). In conclusion, the trial failed to demonstrate clear evidence of a difference in efficacy. However, differences of up to 36% greater rates of caries in the intensive group could not be ruled out, thus equivalence of the treatments cannot be concluded.

Racial and ethnic differences in a regular source of dental care and the oral health, behaviors, beliefs and services of low-income mothers.

OBJECTIVE: In a racial/ethnically-diverse sample of low-income mothers of children aged 3-6, we determine: (1) whether a regular source of dental care (RSDC), self-rated oral health, beliefs and behaviors differ by racial/ethnic group; (2) estimate whether a RSDC is associated with oral health, beliefs and behaviors, and whether these associations differ by racial/ethnic group; and (3) examine these relationships for mothers' dental utilization. BASIC RESEARCH DESIGN: Cross-sectional survey. Participants From a population of 108,151 Medicaid children aged 3-6 in Washington state, U.S., 10,909 eligible children were sampled stratified by racial/ethnic group. Eligible mothers completed a mixed-mode survey in the following groups: Black (n=818), Hispanic (n=1310), or White (n=1382). MAIN OUTCOME MEASURES: Measures were mothers' RSDC, personal characteristics, self-rated dental health, appearance of teeth, dental problems, brushing duration, flossing frequency, use of toothpicks or whiteners, belief that cleaning prevents cavities or loose teeth, and self-reported services at last dental visit. RESULTS: About 38-40% of mothers had a RSDC. For Black, Hispanic and White mothers, having a RSDC was associated consistently with better oral health, greater likelihood of a dental cleaning and less likelihood of tooth extraction. RSDC was not associated generally with oral health beliefs and behaviors. Oral health behaviors differ by racial/ethnic group. CONCLUSIONS: Relationships between RSDC and self-reported oral health, health behaviors, beliefs and dental services are similar for Black, Hispanic and White low-income mothers of young children. Oral health behaviors differ across racial/ethnic groups, which may have implications for mother and child oral health.