Monetary incentives for improving smartphone-measured oral hygiene behaviors in young children: A randomized pilot trial.

AIMS: To assess feasibility, acceptability, and early efficacy of monetary incentive-based interventions on fostering oral hygiene in young children measured with a Bluetooth-enabled toothbrush and smartphone application. DESIGN: A stratified, parallel-group, three-arm individually randomized controlled pilot trial. SETTING: Two Los Angeles area Early Head Start (EHS) sites. PARTICIPANTS: 36 parent-child dyads enrolled in an EHS home visit program for 0-3 year olds. INTERVENTIONS: Eligible dyads, within strata and permuted blocks, were randomized in equal allocation to one of three groups: waitlist (delayed monetary incentive) control group, fixed monetary incentive package, or lottery monetary incentive package. The intervention lasted 8 weeks. OUTCOMES: Primary outcomes were a) toothbrushing performance: mean number of Bluetooth-recorded half-day episodes per week when the child's teeth were brushed, and b) dental visit by the 2-month follow-up among children with no prior dental visit. The a priori milestone of 20% more frequent toothbrushing identified the intervention for a subsequent trial. Feasibility and acceptability measures were also assessed, including frequency of parents syncing the Bluetooth-enabled toothbrush to the smartphone application and plaque measurement from digital photographs. FINDINGS: Digital monitoring of toothbrushing was feasible. Mean number of weekly toothbrushing episodes over 8 weeks was 3.9 in the control group, 4.1 in the fixed incentive group, and 6.0 in the lottery incentive group. The lottery group had 53% more frequent toothbrushing than the control group and 47% more frequent toothbrushing than the fixed group. Exploratory analyses showed effects concentrated among children ≤24 months. Follow-up dental visit attendance was similar across groups. iPhone 7 more reliably captured evaluable images than Photomed Cannon G16. CONCLUSIONS: Trial protocol and outcome measures were deemed feasible and acceptable. Results informed the study protocol for a fully powered trial of lottery incentives versus a delayed control using the smart toothbrush and remote digital incentive program administration. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03862443.

Developing and Testing Electronic Health Record-Derived Caries Indices.

Caries indices, the basis of epidemiologic caries measures, are not easily obtained in clinical settings. This study's objective was to design, test, and validate an automated program (Valid Electronic Health Record Dental Caries Indices Calculator Tool [VERDICT]) to calculate caries indices from an electronic health record (EHR). Synthetic use case scenarios and actual patient cases of primary, mixed, and permanent dentition, including decayed, missing, and filled teeth (DMFT/dmft) and tooth surfaces (DMFS/dmfs) were entered into the EHR. VERDICT measures were compared to a previously validated clinical electronic data capture (EDC) system and statistical program to calculate caries indices. Four university clinician-researchers abstracted EHR caries exam data for 45 synthetic use cases into the EDC and post-processed with SAS software creating a gold standard to compare the -VERDICT-derived caries indices. Then, 2 senior researchers abstracted EHR caries exam data and calculated caries indices for 24 patients, allowing further comparisons to VERDICT indices. Agreement statistics were computed among abstractors, and discrepancies were resolved by consensus. Agreement statistics between the 2 final-phase abstractors and the VERDICT measures showed extremely high concordance: Lin's concordance coefficients (LCCs) >0.99 for dmfs, dmft, DS, ds, DT, dt, ms, mt, FS, fs, FT, and ft; LCCs >0.95 for DMFS and DMFT; and LCCs of 0.92-0.93 for MS and MT. Caries indices, essential to developing primary health outcome measures for research, can be reliably derived from an EHR using VERDICT. Using these indices will enable population oral health management approaches and inform quality improvement efforts.

Calibration of dentists for Caries Management by Risk Assessment Research in a Practice Based Research Network - CAMBRA PBRN.

BACKGROUND: To prove that Caries Management by Risk Assessment (CAMBRA) can be successfully implemented in dental practices outside of the university setting, dentists in the San Francisco Bay Area (CA) were approached to participate in a Practice Based Research Network (PBRN) study. The overall goal of the CAMBRA-PBRN study was to recruit 30 dentists to perform a two-year study involving approximately 900 patients. Goal of the calibration study was to standardize and calibrate dentists potentially participating in the CAMBRA-PBRN study. METHODS: To minimize inter-examiner variability in data collection, including classification of carious lesions and recording of existing restorations, participating dentists were trained and calibrated in accurate DMFS (decayed, missing, filled surfaces) charting. Dentists were also trained and calibrated to diagnose and differentiate between sound surfaces and non-cavitated caries lesions (International Caries Detection and Assessment - ICDAS scores 1 and 2) for posterior occlusal surfaces. Thirty dentists were calibrated to a single gold standard examiner (BJ) during 6 calibration sessions, between 2011 and 2014. Kappa statistics were used to determine inter-examiner reliability on 13 or more patients, aged 12-63 (average age 38 ± 15 years), per examiner during each session, resulting in 94 patient encounters over the course of all 6 sessions. To participate in the main study, examiners needed to achieve a minimum required kappa of 0.75. During the calibration process, examiners scored between 1036 and 2220 tooth surfaces. RESULTS: The kappa values (unweighted kappa) of the participating dentists compared to the gold standard examiner ranged from 0.75 to 0.90, with an average kappa of 0.84 ± 0.03. 90% of the examiners achieved overall kappa values above 0.8. However, separate reliability for assessment of non-cavitated lesions, as in other studies, was lower (0.55 ± 0.15). Multiple subcategories were evaluated. All dentists reached sufficient reliability values to proceed into the study; nevertheless, one dentist discontinued with the study due to scheduling conflicts. CONCLUSIONS: The high inter-examiner reliability results have shown that dentists who work in primarily non-research based practices can be effectively standardized and calibrated in data collection, based on specific guidelines created to anticipate potential research study scenarios.

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.

Examination criteria and calibration procedures for prevention trials of the Early Childhood Caries Collaborating Centers.

OBJECTIVES: To summarize diagnostic criteria and examiner training and calibration of the National Institute of Dental and Craniofacial Research-funded Early Childhood Caries Collaborating Centers (EC4) and report examiner calibration results from 2010 to 2014. The EC4 at Boston University, University of Colorado, and University of California San Francisco are performing randomized controlled early childhood caries (ECC) prevention trials with caries as the main outcome measure. METHODS: The EC4 with University of Iowa consultants developed standardized tooth and tooth surface status examination criteria for use in field conditions, examiner training materials, and examiner calibration and re-calibration methodologies. Calibration and re-calibration were performed with 1- to 5-year-old children in the San Francisco Mission District in which assessments from each examiner to be calibrated were compared with those from a single gold standard examiner from 2010 to 2014. Cohen's kappa statistic was used to determine inter-examiner agreement. RESULTS: A total of seven examiners were successfully (re)calibrated during that period, examining a total of 231 children. Overall unweighted Cohen's kappas for 10 surface conditions exceeded the criterion of 0.70. However, separate agreement for assessment of noncavitated lesions, as in other studies, was lower. CONCLUSIONS: An experienced multidisciplinary and multi-institutional team was able to develop criteria and training materials to anticipate situations and field conditions the main trials would encounter. Examiners were successfully trained and (re)calibrated.

Clinically determined and self-reported dental status during and after pregnancy among low-income Hispanic women.

OBJECTIVES: This analysis assessed, during and 1 year after pregnancy: a) the prevalence of and relationship between self-reported and clinically determined dental caries and oral health status, and whether self-reports are a potential proxy for professional determination; and b) factors associated with high levels of professionally determined or self-reported oral disease. METHODS: Data are from a randomized clinical trial of 301 pregnant, low-income Hispanic women at the California-Mexico border to compare two interventions to prevent early childhood caries. Interviews and dental examinations were conducted at enrollment (second trimester) and 1-year postpartum (PP). RESULTS: During pregnancy and PP, 93 percent had untreated caries and most had gingival inflammation. Sensitivity and specificity of self-reported measures compared to dentists' determinations were modest (ranging from 45-80 percent for sensitivity and 41-77 percent for specificity at both time points); positive predictive values for women reporting current tooth decay or fair/poor oral health were high (>94 percent), but negative predictive values were low (<23 percent). In a bivariate GEE model, factors associated with fair/poor self-reported oral health during and after pregnancy included self-reported dental symptoms (current tooth decay, bleeding gums without brushing), dental behaviors (not flossing) and number of decayed tooth surfaces. In a logistic regression model, the only significant factor PP associated with less extensive untreated disease was if women ever had their teeth cleaned professionally (OR = 0.44). CONCLUSIONS: There is a great need for dental treatment in this underserved population both during pregnancy and PP. Women may not be able to accurately recognize or act on their treatment needs. At baseline and PP, few demographic or behavioral factors were associated with either self-reported or clinically determined oral disease (e.g., being less educated or acculturated and not flossing) in the bivariate analyses. Ever having a professional teeth cleaning significantly predicted less disease PP.

Mother and youth access (MAYA) maternal chlorhexidine, counselling and paediatric fluoride varnish randomized clinical trial to prevent early childhood caries.

BACKGROUND: Mexican-American children have a higher caries prevalence than the U.S. average. The Mothers and Youth Access (MAYA) study was a randomized clinical trial initiated to address this problem. AIM: Comparison of the efficacy of two prevention interventions in reducing early childhood caries (ECC). DESIGN: All 361 randomized mother-child dyads received oral health counselling. Beginning at 4 months postpartum, intervention mothers received chlorhexidine (CHX) mouthrinse for 3 months beginning 4 months postpartum and children received fluoride varnish (FV) every 6 months from age 12-36 months. Control group children received FV if precavitated lesions developed. Salivary mutans streptococci (MS) and lactobacilli were assessed. RESULTS: No significant difference in children's 36-month caries incidence between groups; 34% in each group developed caries [(d(2+) fs) > 0]. About half of control group developed precavitated lesions and received therapeutic FV. Maternal MS levels declined during CHX use, but increased when discontinued. CONCLUSIONS: Maternal postpartum CHX regimen, oral health counselling and preventive child FV applications were not more efficacious than maternal counselling with child therapeutic FV for precavitated lesions for ECC prevention. FV for young children with brief maternal CHX use and oral health counselling may need to be combined with additional or longer-term therapies to significantly reduce ECC in high-risk populations.

Recruiting and retaining pregnant women from a community health center at the US-Mexico border for the Mothers and Youth Access clinical trial.

BACKGROUND: Recruitment and retention in clinical trials of minorities is low, particularly in rural underserved populations. This has slowed progress in addressing racial/ethnic disparities in oral health. PURPOSE: To describe factors associated with successful recruitment, and identify predictors of continued retention of pregnant women attending a community health center into a randomized controlled clinical trial to prevent early childhood caries. METHODS: The Mothers and Youth Access (MAYA) Trial recruited women in the second trimester of pregnancy. At baseline, consenting women completed an oral health questionnaire and received a dental exam and oral health counseling. Four months postpartum, women returned with their babies for randomization with follow up at 9-, 12-, 18-, 24-, 30-, and 36-month postpartum visits. To assess predictors of retention, data about respondents' demographics, and oral health-related knowledge, attitudes, and behaviors were obtained by questionnaire and analyzed by logistic and discrete time-to-event regression analyses. RESULTS: Of 556 predominantly Mexican-American women recruited at baseline, 195 (35%) were excluded after baseline for not meeting inclusion criteria; 361 (65%) continued to randomization. Factors such as race/ethnicity, annual household income, household composition, oral health-related knowledge and behaviors significantly related to retention until randomization. In multivariable models, women reporting a higher annual household income were less likely to be lost to attrition before randomization (odds ratio = 0.73, 95% confidence interval (CI) 0.60-0.89); while Mexican/Mexican-American women were less likely to be lost beyond randomization (hazard ratio = 0.53, 95% CI 0.26-1.08). LIMITATIONS: Factors not measured at baseline may have been important in predicting attrition. The MAYA Trial is expected to finish by November 2008; therefore, complete results for total retention may differ from those reported here. CONCLUSIONS: Recruitment and retention efforts for pregnant Hispanic women should place heavy emphasis on culture as ethnicity remained the only borderline significant predictor in postrandomization retention.