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.

The basic research factors questionnaire for studying early childhood caries.

BACKGROUND: We describe development of the Early Childhood Caries (ECC) Basic Research Factors Questionnaire (BRFQ), a battery of measures assessing common potential predictors, mediators, and moderators of ECC. Individual-, family-, and community-level factors that are linked to oral health outcomes across at-risk populations are included. Developing standard measures of factors implicated in ECC has the potential to enhance our ability to understand mechanisms underlying successful prevention and to develop more effective interventions. METHODS: The Early Childhood Caries Collaborating Centers (EC4), funded by National Institute of Dental and Craniofacial Research, developed the BRFQ, which was used across four randomized trials to develop and test interventions for reducing ECC in at-risk populations. Forty-five investigators from across the centers and NIDCR were involved in the development process. Eight "measures working groups" identified relevant constructs and effective measurement approaches, which were then categorized as "essential" or "optional" common data elements (CDEs) for the EC4 projects. RESULTS: Essential CDEs include 88 items, with an additional 177 measures categorized as optional CDEs. Essential CDEs fell under the following domains: oral health knowledge, oral health behavior, utilization/insurance and cost, parent/caregiver dental self-efficacy, quality of life, caregiver and family characteristics, and child characteristics. CONCLUSIONS: The BRFQ makes available a battery of measures that support efforts to understand population risk factors for ECC and to compare oral health outcomes across populations at risk. The BRFQ development process may be useful to other clinical research networks and consortia developing CDEs in other health research fields. TRIAL REGISTRATION: All the trial that used the BRFQ were registered at Clinicaltrial.gov NCT01116726 , April 29, 2010; NCT01116739 , May 3, 2010; NCT01129440 , May 21, 2010; and NCT01205971 , September 19, 2010.

Recruitment for health disparities preventive intervention trials: the early childhood caries collaborating centers.

BACKGROUND: Four trials of interventions designed to prevent early childhood caries are using community-engagement strategies to improve recruitment of low-income, racial/ethnic minority participants. The trials are being implemented by 3 centers funded by the National Institute of Dental and Craniofacial Research and known as the Early Childhood Caries Collaborating Centers (EC4): the Center for Native Oral Health Research at the University of Colorado, the Center to Address Disparities in Children's Oral Health at the University of California San Francisco, and the Center for Research to Evaluate and Eliminate Dental Disparities at Boston University. COMMUNITY CONTEXT: The community contexts for the EC4 trials include urban public housing developments, Hispanic communities near the US-Mexican border, and rural American Indian reservations. These communities have a high prevalence of early childhood caries, suggesting the need for effective, culturally acceptable interventions. METHODS: Each center's intervention(s) used community-based participatory research approaches, identified community partners, engaged the community through various means, and developed communication strategies to enhance recruitment. OUTCOME: All 3 centers have completed recruitment. Each center implemented several new strategies and approaches to enhance recruitment efforts, such as introducing new communication techniques, using media such as radio and newspapers to spread awareness about the studies, and hosting community gatherings. INTERPRETATION: Using multiple strategies that build trust in the community, are sensitive to cultural norms, and are adaptable to the community environment can enhance recruitment in underserved communities.

Association of Ethnic Identity with Oral Health Knowledge, Attitudes, Behavior, and Outcomes on the Navajo Nation.

American Indians and Alaska Natives (AI/ANs) experience poor oral health. Children and adults living on the Navajo Nation have a particularly high rate of dental decay. The literature suggests that health outcomes are often associated with the strength of one's ethnic identity. We investigated the association of ethnic identity among Native parents with oral health knowledge, attitudes, behavior, and outcomes. Analyses used baseline data from a randomized controlled trial designed to reduce dental decay among AI/AN preschoolers enrolled in the Navajo Nation Head Start Program. Greater perceived importance of ethnic identity was associated with better oral health knowledge and attitudes but was unassociated with oral health behavior and was linked to worse oral health status. Parents who were better able to speak their tribal language had greater confidence in their ability to manage their children's oral health, engaged in better oral health behavior, and reported better parental oral health status.

Parental psychosocial factors and childhood caries prevention: Data from an American Indian population.

OBJECTIVES: The objective of this study was to examine the association among psychological and social variables reported by American Indian parents/caregivers of preschool children and changes in their Oral Health Knowledge and Behaviors related to care of their children's teeth. We also investigated the relationship of these factors with progression of caries, as reflected by changes in their children's dmfs. METHODS: The data used for this study were collected at baseline in a clinical trial of an oral health promotion intervention comprising behavioural and clinical interventions for caries prevention delivered by tribal members on a large Southwestern American Indian reservation. Linear regression analyses were performed for changes (baseline to Year 1) in dmfs, Oral Health Knowledge and Oral Health Behavior scores, with baseline psychosocial measures, taken individually, as the independent variables. RESULTS: Parents' attitudes and beliefs were associated with increases in their Oral Health Knowledge and Behavior and also with the progression of caries for their children. When all participants were considered together, increases in children's dmfs were smaller when the caregiver had higher Internal Oral Health Locus of Control (e = -1.33, P = .004), higher Health Literacy (e = -1.55, P < .01), and higher Financial Stability (e = -4.46, P = .03), and lower scores for the Barriers subscale (e = 1.57, P < .01) of the Health Belief Model. For parents in the Intervention group, higher scores on Locus of Control, reflecting beliefs that chance, or other people determine their children's oral health, were associated with larger increases in Oral Health Knowledge (e = 1.73, P = .04) and Behaviors (e = 4.00, P = .005). CONCLUSIONS: Prevention of early childhood caries in American Indian children has proved to be especially challenging. Some of the measures identified in this report may suggest promising directions to prevention through approaches that build on competencies and skills to be learned and used within a context more broadly focused on parenting and management of health and family challenges.

Validity of Measures Assessing Oral Health Beliefs of American Indian Parents.

OBJECTIVES: This aimed to validate measures of constructs included in an extended Health Belief Model (EHBM) addressing oral health beliefs among American Indian (AI) parents. METHODS: Questionnaire data were collected as part of a randomized controlled trial (n = 1016) aimed at reducing childhood caries. Participants were AI parents with a preschool-age child enrolled in the Navajo Nation Head Start program. Questionnaire items addressed five EHBM constructs: perceived susceptibility, severity, barriers, benefits, and parental self-efficacy. Subscales representing each construct underwent reliability and validity testing. Internal consistency reliability of each subscale was evaluated using Cronbach's alpha. Convergent validity was assessed using linear regression to evaluate the association of each EHBM subscale with oral health-related measures. RESULTS: Internal consistency reliability was high for self-efficacy (α = 0.83) and perceived benefits (α = 0.83) compared to remaining EHBM subscales (α < 0.50). Parents with more education (p < 0.0001) and income (p = 0.0002) perceived dental caries as more severe younger parents (ps = 0.02) and those with more education (ps < 0.0001) perceived greater benefits and fewer barriers to following recommended oral health behavior. Female parents (p < 0.0001) and those with more education (p = 0.02) had higher levels of self-efficacy. Parental knowledge was associated with all EHBM measures (ps < 0.0001) excluding perceived susceptibility (p > 0.05). Parents with increased self-efficacy had greater behavioral adherence (p < 0.0001), whereas lower behavioral adherence was associated with parents who reported higher perceived barriers (p < 0.0001). Better pediatric oral health outcomes were associated with higher levels of self-efficacy (p < 0.0001) and lower levels of perceived severity (p = 0.02) and barriers (p = 0.05). CONCLUSIONS: Results support the value of questionnaire items addressing the EHBM subscales, which functioned in a manner consistent with the EHBM theoretical framework in AI participants.

Fidelity of motivational interviewing in an American Indian oral health intervention.

OBJECTIVES: Assess fidelity of a motivational interviewing (MI) intervention focused on preventing early childhood caries in a cohort of American Indian mothers with newborns. METHODS: Four interventionists were trained to administer an oral health MI intervention. The MI sessions were audio recorded to enable scoring as part of fidelity studies to assess the interventionist's degree of competence in using MI principles. Evaluation of the interventionists was completed using the Motivational Interviewing Treatment Integrity (MITI) 3.1.1. which assesses global ratings and behaviour counts. Two reviewers evaluated and scored the MI sessions; a random sample of twenty per cent of the total interviews was scored by a trained reviewer and fifty per cent of the randomly selected files scored by an external expert. A total of 225 files were coded by the trained reviewer and 121 files by the external expert. RESULTS: Mean global scores for all interventionists combined were around 4.0 (expert competence). Scores for reflection to question ratios (around 0.6) were below beginner competence. Scores ranged from beginner to expert competence for open-ended questions (54%-56%), complex reflections (38%-43%) and MI-adherent statements (93%-95%). There was variation in competence for the four interventionists when analysed individually. Inter-rater reliability scores for the two reviewers ranged from fair (0.40-0.59) to good (0.60-0.74). The MI interventionist rated the best in the fidelity assessment had the worst study outcomes compared to other interventionists. CONCLUSIONS: Individual interventionists' scores for the MITI global ratings and behaviour counts reflected variation in competence and ranged from below beginner to expert levels. A higher competence level of the interventionist as assessed by the fidelity study was not related to better study outcomes.

Retention strategies for health disparities preventive trials: findings from the Early Childhood Caries Collaborating Centers.

OBJECTIVES: To identify successful strategies for retention of participants in multiyear, community-based randomized controlled trials (RCTs) aiming to reduce early childhood caries in health disparities populations from diverse racial/ethnic backgrounds and across diverse geographic settings. METHODS: Four RCTs conducted by the Early Childhood Caries Collaborating Centers (EC4), an initiative of the National Institute of Dental and Craniofacial Research, systematically collected information on the success of various strategies implemented to promote participant retention in each RCT. The observational findings from this case series of four RCTs were tabulated and the strategies rated by study staff. RESULTS: Participant retention at 12 months of follow-up ranged from 52.8 percent to 91.7 percent, and at 24 months ranged from 53.6 percent to 85.9, across the four RCTs. For the three RCTs that had a 36-month follow-up, retention ranged from 53.6 percent to 85.1 percent. Effectiveness of different participant retention strategies varied widely across the RCTs. CONCLUSIONS: Findings from this case series study may help to guide the design of future RCTs to maximize retention of study participants and yield needed data on effective interventions to reduce oral health disparities.

American Indian and Alaska Native Access to Oral Health Care: A Potential Solution.

UNLABELLED: American Indians and Alaska Natives (AI/AN) experience significant health disparities relative to the general U.S. POPULATION: In particular, oral diseases affect the majority of the AI/AN population and their prevalence is significantly greater than observed in other demographic sectors of the U.S. POPULATION: The reasons for these disparities are multiple but lack of access to dental care is clearly a contributing factor. The dentist-to-population ratio in many AI/AN communities is less than half the U.S. average. A solution has been developed in Alaska by AI/AN leaders: dental therapists, i.e., local people trained for two years to provide basic dental services. This solution is being fought by organized dentistry that sees the approach as an economic threat, but AI/AN organizations are committed to implementing this Native solution to their access problem. The Alaska experience indicates that access to oral health services can be improved through the addition of dental therapists to the dental team.

American Indian and Alaska Native Access to Oral Health Care: A Potential Solution.

American Indians and Alaska Natives (AI/AN) experience significant health disparities relative to the general U.S. POPULATION: In particular, oral diseases affect the majority of the AI/AN population and their prevalence is significantly greater than observed in other demographic sectors of the U.S. POPULATION: The reasons for these disparities are multiple but lack of access to dental care is clearly a contributing factor. The dentist-to-population ratio in many AI/AN communities is less than half the U.S. average. A solution has been developed in Alaska by AI/AN leaders: dental therapists, i.e., local people trained for two years to provide basic dental services. This solution is being fought by organized dentistry that sees the approach as an economic threat, but AI/AN organizations are committed to implementing this Native solution to their access problem. The Alaska experience indicates that access to oral health services can be improved through the addition of dental therapists to the dental team.

Validation and Impact of Caregivers' Oral Health Knowledge and Behavior on Children's Oral Health Status.

PURPOSE: To validate oral health knowledge and behavior measures from the Basic Research Factors Questionnaire, developed to capture specific themes contributing to children's oral health outcomes and the influence of caregivers. METHODS: Data were collected as part of a randomized clinical trial (n equals 992) aimed at reducing dental caries in young children. Participants were American Indian/Alaska Native caregivers with a three- to five-year-old child enrolled in a Navajo Nation Head Start Center. Caregivers completed the questionnaire at enrollment with concomitant evaluation of children for decayed, missing, and filled tooth surfaces (dmfs). Oral health knowledge and behavior outcomes were compared with convergent measures (participant sociodemographic characteristics, oral health attitudes, and indicators of oral health status). RESULTS: Caregiver oral health knowledge was significantly associated with education, income, oral health behavior, and all but one of the oral health attitude measures. Behavior was significantly associated with several measures of oral health attitudes and all but one measure of oral health status. As the behavior score improved, dmfs scores declined, child/caregiver overall oral health status improved, and pediatric oral health quality of life improved. CONCLUSIONS: Questionnaire measures were valid for predicting specific caregiver factors potentially contributing to children's oral health status.

Learning from caries-free children in a high-caries American Indian population.

OBJECTIVE: We aimed to identify salutogenic patterns of parental knowledge, behaviors, attitudes, and beliefs that may support resistance to early childhood caries (ECC) among a high caries population of preschool American Indian (AI) children. METHOD: Participants were 981 child-parent dyads living on a Southwestern reservation who completed baseline assessments for an ongoing randomized clinical trial. T-tests were used to assess differences between reported knowledge, behaviors, and beliefs of parents whose children were caries-free (10.7 percent) and those whose children had caries (89.3 percent). Chi-square analyses were used for categorical variables. RESULTS: Although there were no socio-demographic differences, parents of caries-free children viewed oral health as more important and reported more oral health knowledge and adherence to caries-preventing behaviors for their children. Parents of caries-free children were more likely to have higher internal locus of control, to perceive their children as less susceptible to caries, and to perceive fewer barriers to prevention. These parents also had higher sense of coherence scores and reported lower levels of personal distress and community-related stress. CONCLUSIONS: Effective interventions for ECC prevention in high-caries AI populations may benefit from approaches that support and model naturally salutogenic behaviors.