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Silver diamine fluoride versus therapeutic sealants for the arrest and prevention of dental caries in low-income minority children: study protocol for a cluster randomized controlled trial

Ruff, Ryan Richard; Niederman, Richard
BACKGROUND:Dental caries is the most prominent childhood disease in the world. In the United States, more than 50% of children have experienced caries. Untreated caries can have negative impacts on quality of life, academic performance, and school attendance. To reduce oral health disparities, multiple organizations recommend school-based caries prevention. METHODS/DESIGN/METHODS:A longitudinal, cluster randomized, non-inferiority trial will be conducted in low-income children from primarily Hispanic/Latino backgrounds currently enrolled in public elementary schools in New York City, New York, United States, from 2018 to 2023. The primary objective is to compare the non-inferiority of silver diamine fluoride and fluoride varnish versus glass ionomer therapeutic sealants and fluoride varnish in the arrest and prevention of dental caries. Secondary objectives are to evaluate differences in effectiveness when care is provided by nurses versus dental hygienists and assess the impact of prevention on oral health-related quality of life and educational outcomes. Caries arrest will be evaluated after 2 years, and caries prevention and secondary outcomes will be assessed at the completion of the study. Data analysis will follow intent-to-treat, and statistical analyses will be conducted using a two-sided significance level of 0.05. DISCUSSION/CONCLUSIONS:The comparative effectiveness of alternative caries prevention delivery models is considered to be one of the highest research priorities in the United States. Many treatments are currently available to prevent and arrest dental caries. The simplicity and affordability of silver diamine fluoride may be a viable alternative for the prevention of dental caries in high-risk children. TRIAL REGISTRATION/BACKGROUND:U.S. National Library of Medicine, www.clinicaltrials.gov , ID: NCT03442309 . Registered on 22 February 2018.
PMID: 30257696
ISSN: 1745-6215
CID: 3314362

Total observed caries experience: assessing the effectiveness of community-based caries prevention

Ruff, Ryan Richard
OBJECTIVES/OBJECTIVE:To compare common measures for dental caries in longitudinal caries research in support of a new measure, the Total Observed Caries Experience (TOCE). METHODS:TOCE was calculated as the total number of decayed or filled teeth ever observed. TOCE was compared to dmft, DMFT, and the prevalence of untreated decay using data from a 4-year, cluster randomized community-based caries prevention program. Outcomes were analyzed using generalized estimating equations and assessed change over time and effects across treatment groups. RESULTS:For TOCE and DMFT, the risk of caries over time increased. In contrast, risks decreased for dmft and the prevalence of untreated decay, driven largely by decayed primary teeth being exfoliated. Effects across treatment groups showed increased risk for some outcomes and attenuated risks in others; however, treatment effects for TOCE were more in line with expected results when compared with controls. CONCLUSIONS:TOCE accounts for caries on primary and permanent dentition and is not subject to bias due to exfoliation. It can be used as a robust measure to evaluate community-based caries prevention programs.
PMID: 30114726
ISSN: 1752-7325
CID: 3241172

Comparative effectiveness of treatments to prevent dental caries given to rural children in school-based settings: protocol for a cluster randomised controlled trial

Ruff, Ryan Richard; Niederman, Richard
INTRODUCTION/BACKGROUND:Dental caries is the most prevalent childhood disease in the world and can lead to infection, pain and reduced quality of life. Multiple prevention agents are available to arrest and prevent dental caries; however, little is known of the comparative effectiveness of combined treatments when applied in pragmatic settings. The aim of the presented study is to compare the benefit of silver diamine fluoride and fluoride varnish versus fluoride varnish and glass ionomer therapeutic sealants in the arrest and prevention of dental caries. METHODS AND ANALYSIS/UNASSIGNED:A longitudinal, pragmatic, cluster randomised, single-blind, non-inferiority trial will be conducted in low-income rural children enrolled in public elementary schools in New Hampshire, USA, from 2018 to 2023. The primary objective is to compare the non-inferiority of alternative agents in the arrest and prevention of dental caries. The secondary objective is to compare cost-effectiveness of both interventions. Caries arrest will be evaluated after 2 years, and caries prevention will be assessed at the completion of the study. Data analysis will follow intent to treat, and statistical analyses will be conducted using a significance level of 0.05. ETHICS AND DISSEMINATION/UNASSIGNED:The standard of care for dental caries is office-based surgery, which presents multiple barriers to care including cost, fear and geographic isolation. The common intervention used in school-based caries prevention is dental sealants. The simplicity and affordability of silver diamine fluoride may be a viable alternative for the prevention of dental caries in high-risk children. Results can be used to inform policy for best practices in school-based oral healthcare. TRIAL REGISTRATION/BACKGROUND:NCT03448107. Pre-results.
PMCID:5905731
PMID: 29654053
ISSN: 2044-6055
CID: 3037552

School-Based Caries Prevention, Tooth Decay, and the Community Environment

Ruff, R R; Niederman, R
The school and community context can contribute to inequity in child oral health. Whether the school and community affect the effectiveness of school-based caries prevention is unknown. The association between the school and community environment and dental caries, as well as their moderating effects with school-based caries prevention, was assessed using multilevel mixed-effects regression. Data were derived from a 6-y prospective cohort study of children participating in a school-based caries prevention program. For the school and community, living in a dental-shortage area and the proportion of children receiving free or reduced lunch were significantly related to an increased risk of dental caries at baseline. Caries prevention was associated with a significant per-visit decrease in the risk of untreated caries, but the rate of total caries experience increased over time. Caries prevention was more effective in children who had prior dental care at baseline and in schools with a higher proportion of low socioeconomic status students. There was significant variation across schools in the baseline prevalence of dental caries and the effect of prevention over time, although effects were modest. The school and community environment have a direct impact on oral health and moderate the association between school-based caries prevention and dental caries.Knowledge Transfer Statement:School-based caries prevention can be an effective means to reduce oral health inequity by embedding dental care within schools. However, the socioeconomic makeup of schools and characteristics of the surrounding community can affect the impact of school-based care.
PMCID:5858650
PMID: 29568803
ISSN: 2380-0844
CID: 3001232

Development and validation of the child oral health impact profile-preschool (COHIP-PS) [Meeting Abstract]

Sischo, L; Ruff, R; Magee, L; Crerand, C; Rosenberg, J; Leblanc, E; Drake, A; Chibbaro, P; Johns, A; Baylis, A; Broder, H
Background/Purpose: Quality of life (QoL) is an integral parameter in understanding, assessing, and improving children's well-being across health conditions. Assessing oral health-related quality of life (OHRQoL) is crucial to evaluating patient well-being and measuring treatment efficacy in those with oral-facial conditions. The Child Oral Health Impact Profile (COHIP) is a validated instrument created to measure the OHRQoL of school-aged children (ages 8-18), yet no measure of OHRQoL exists for preschool children. The purpose of this study was to develop and validate a preschool version of the COHIP (COHIP-PS) for children aged 2 to 5. Methods/Description: A standard multistage process consisting of item selection, face validity testing, item impact testing, reliability and validity testing, and confirmatory factor analysis was used to develop the COHIP-PS. A cross-sectional convenience sample of caregivers with children 2 to 5 years old from 4 groups at varying locations completed the item clarity and impact forms. Groups were recruited from pediatric health clinics or preschools/day care centers, speech clinics, dental clinics, or cleft/craniofacial centers. Participants' children had a variety of oral health-related conditions, including caries, cleft lip and/or palate, or speech/language disorders.
Result(s): A total of 327 caregivers were included in the sample. Participants included caregivers from the cleft group (n = 81), speech group (n = 69), community group (n = 75), and dental group (n = 102). Approximately 84% of the overall caregiver sample were female, whereas 48% of the children were female. For children, 43% were white, followed by 33% Latino, 11% black, 7% Pacific Islander, 4.7% Other, and 1.5% Indian. For the cleft sample, children had cleft lip and palate (62%), cleft palate only (29%), or cleft lip only (9%). The COHIP-PS was found to have acceptable internal validity (= 0.71) and high test-retest reliability (0.87). Although discriminant validity results indicated significant differences across study groups, the overall magnitude of differences was modest. Results from confirmatory factor analyses support the use of a 4-factor model consisting of 12 items across oral health, functional well-being, socialemotional well-being, and self-image domains.
Conclusion(s): QoL is integral factor in understanding and assessing children's well-being. The COHIP-PS is a validated OHRQoL measure for preschool children with cleft or other oral conditions
EMBASE:629011245
ISSN: 1545-1569
CID: 4051452

Comparative effectiveness of school-based caries prevention: a prospective cohort study

Ruff, Ryan Richard; Niederman, Richard
BACKGROUND:Dental caries is the world's most prevalent childhood disease. School-based caries prevention can reduce the risk of childhood caries by increasing access to care. However, the optimal mix of treatment services, intensity, and frequency of care is unknown. METHODS:Data were derived from two prospective cohorts of US children participating in two caries prevention programs with different treatment intensities. One program provided primary and secondary prevention (glass ionomer sealants and interim therapeutic restorations) and one primary prevention only (glass ionomer sealants), both given twice yearly in six-month intervals. Primary study outcomes included untreated decay and the total observed caries experience. Analysis used generalized additive models to estimate nonlinear effects and trends over time. Results were compared to those estimated using generalized estimating equations and mixed-effects multilevel Poisson regression. RESULTS:Primary and secondary prevention combined did not significantly reduce total caries experience compared to primary prevention alone, but did reduce the risk of untreated decay on permanent dentition. Additionally, the rate of new caries experience was slower in the primary and secondary prevention group. Nonlinear trends for dental caries across both programs were statistically significant from zero (p < .001). CONCLUSION/CONCLUSIONS:Caries prevention consisting of primary and secondary prevention agents may be more effective than primary prevention alone in reducing the risk of tooth decay over time. Results suggest that the impact of caries prevention may not be constant over the medium- and long-term, suggesting reduced effectiveness with continued treatments.
PMCID:5872543
PMID: 29587715
ISSN: 1472-6831
CID: 3010182

Surgical Care for School-Aged Youth With Cleft: Results From a Multicenter, Prospective Observational Study

Ruff, Ryan Richard; Crerand, Canice E; Sischo, Lacey; Peshansky, Alexandre; Sarwer, David B; Kirschner, Richard E; Broder, Hillary L
OBJECTIVE:To explore factors related to completion of surgery recommendations among children with cleft lip and palate (CLP) or cleft palate only (CPO). DESIGN/METHODS:Multicenter prospective longitudinal cohort study (2009-2015). SETTING/METHODS:Six cleft centers in the United States. PATIENTS/PARTICIPANTS/METHODS:A diverse sample of 1186 youth aged 7.5 to 18.5 years with CLP or CPO and a caregiver. RESULTS:Data were collected from child-caregiver dyads at baseline and up to 3 follow-up visits. Of the 765 surgeries recommended during the study period, 83 were postponed and 597 were completed; this represents a completion rate of 78%. There were multiple reasons identified by patients for why the remaining 85 recommended surgeries were not completed. Children with nonprivate insurance were more likely to postpone recommended surgeries. Hispanic/Latino and Asian children had fewer surgeries compared to whites/Caucasians. Greater severity in rated speech differences was associated with more surgeries. Among participants who had completed all recommended surgeries, providers rated over 86% as having normal or mildly different facial appearance and 83% as having a normal or mild speech intelligibility rating. Similarly, caregivers rated 80% of facial appearance and 78% of speech positively. Approximately 25% of children had an additional surgical recommendation at the end of the study. CONCLUSIONS:The majority of surgical recommendations were completed with positive outcomes in facial appearance and speech intelligibility by provider and caregiver ratings. Several factors contributed to surgical recommendations not being completed and the results underscore the importance of examining socioeconomic and demographic disparities in surgical care.
PMID: 29554461
ISSN: 1545-1569
CID: 3001252

Neighborhood Stigma and Sleep: Findings from a Pilot Study of Low-Income Housing Residents in New York City

Ruff, Ryan Richard; Ng, Jeannie; Jean-Louis, Girardin; Elbel, Brian; Chaix, Basile; Duncan, Dustin T
The primary objective of this study was to investigate the relationship between neighborhood stigma and sleep in a sample of low-income housing residents in New York City. Data were derived from the NYC Low-Income Housing, Neighborhoods, and Health Study (N = 120). Adults living in low-income housing completed a survey consisting of measures of neighborhood stigma, sleep quality, and sleep duration. Neighborhood stigma and sleep were self-reported. Associations between neighborhood stigma and sleep health were analyzed using generalized linear models with cluster variance estimation. Multivariable models adjusted for age, gender, race/ethnicity, income, education, employment status, obesity, the census block percentage of non-Hispanic black residents, and the census block percentage median household income. Results indicate that a reported negative media perception of the neighborhood was negatively associated with sleep quality and duration (p < 0.01). However, additional research is needed to explore neighborhood stigma as it relates to sleep.
PMID: 27492685
ISSN: 0896-4289
CID: 2199712

The Benefit of Early Preventive Dental Care for Children

Huang, Shulamite S; Ruff, Ryan R; Niederman, Richard
PMID: 28759669
ISSN: 2168-6211
CID: 2655572

Development and validation of the Child Oral Health Impact Profile - Preschool version

Ruff, R R; Sischo, L; Chinn, C H; Broder, H L
OBJECTIVE: The Child Oral Health Impact Profile (COHIP) is a validated instrument created to measure the oral health-related quality of life of school-aged children. The purpose of this study was to develop and validate a preschool version of the COHIP (COHIP-PS) for children aged 2-5. BASIC RESEARCH DESIGN: The COHIP-PS was developed and validated using a multi-stage process consisting of item selection, face validity testing, item impact testing, reliability and validity testing, and factor analysis. PARTICIPANTS: A cross-sectional convenience sample of caregivers having children 2-5 years old from four groups completed item clarity and impact forms. Groups were recruited from pediatric health clinics or preschools/daycare centers, speech clinics, dental clinics, or cleft/craniofacial centers. Participants had a variety of oral health-related conditions, including caries, congenital orofacial anomalies, and speech/language deficiencies such as articulation and language disorders. MAIN OUTCOME MEASURE: COHIP-PS. RESULTS: The COHIP-PS was found to have acceptable internal validity (a = 0.71) and high test-retest reliability (0.87), though internal validity was below the accepted threshold for the community sample. While discriminant validity results indicated significant differences across study groups, the overall magnitude of differences was modest. Results from confirmatory factor analyses support the use of a four-factor model consisting of 11 items across oral health, functional well-being, social-emotional well-being, and self-image domains. CONCLUSIONS: Quality of life is an integral factor in understanding and assessing children's well-being. The COHIP-PS is a validated oral health-related quality of life measure for preschool children with cleft or other oral conditions.
PMID: 28872813
ISSN: 0265-539x
CID: 2688402