Objective This scoping review aims to identify complex health interventions (CHI’s) to prevent early childhood caries (ECC), explore the level of complexity of the identified CHI’s, and explore the details of their development, evaluation, and implementation. Introduction Many interventions to prevent ECC have multiple interacting components and can be seen as CHI’s. Recent reviews on these interventions have found inconclusive effects, which may be due to differences in the development, evaluation, and implementation of CHI’s. Inclusion criteria This scoping review will consider clinical trials reporting CHI’s to prevent ECC that starts during pregnancy or in the first year of life. Studies in the English language will be included regardless of the country of origin, sociocultural setting, or context. Methods This review will follow the Joanna Briggs Institute methodology for scoping reviews. An initial search of PubMed identified keywords and Medical Subject Headings terms. A second search of PubMed, Embase, Clarivate Analytics/Web of Science Core Collection, ClinicalTrials.gov, and the Wiley/Cochrane Library will follow. Two independent reviewers will perform title and abstract screening, retrieve and review full-text studies, and extract data. The reference lists of all included sources will be screened for additional CHI’s or relevant publications about a specific CHI. Data charting will be utilised based on study characteristics and intervention complexity. A 39-item instrument will be used to explore the details in the description of the CHI’s development, evaluation, and implementation. The results will be presented in tables, visual outputs, and a narrative summary in response to the review questions. Discussion The proposed review will generate evidence which may provide a direction for the future design of studies on CHI’s to prevent ECC and more complete information for those who want to adopt successful interventions to prevent ECC.
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Background: Early childhood caries is considered one of the most prevalent diseases in childhood, affecting almost half of preschool-age children globally. In the Netherlands, approximately one-third of children aged 5 years already have dental caries, and dental care providers experience problems reaching out to these children. Objective: Within the proposed trial, we aim to test the hypothesis that, compared to children who receive usual care, children who receive the Toddler Oral Health Intervention as add-on care will have a reduced cumulative caries incidence and caries incidence density at the age of 48 months. Methods: This pragmatic, 2-arm, individually randomized controlled trial is being conducted in the Netherlands and has been approved by the Medical Ethics Research Board of University Medical Center Utrecht. Parents with children aged 6 to 12 months attending 1 of the 9 selected well-baby clinics are invited to participate. Only healthy children (ie, not requiring any form of specialized health care) with parents that have sufficient command of the Dutch language and have no plans to move outside the well-baby clinic region are eligible. Both groups receive conventional oral health education in well-baby clinics during regular well-baby clinic visits between the ages of 6 to 48 months. After concealed random allocation of interventions, the intervention group also receives the Toddler Oral Health Intervention from an oral health coach. The Toddler Oral Health Intervention combines behavioral interventions of proven effectiveness in caries prevention. Data are collected at baseline, at 24 months, and at 48 months. The primary study endpoint is cumulative caries incidence for children aged 48 months, and will be analyzed according to the intention-to-treat principle. For children aged 48 months, the balance between costs and effects of the Toddler Oral Health Intervention will be evaluated, and for children aged 24 months, the effects of the Toddler Oral Health Intervention on behavioral determinants, alongside cumulative caries incidence, will be compared. Results: The first parent-child dyads were enrolled in June 2017, and recruitment was finished in June 2019. We enrolled 402 parent-child dyads. Conclusions: All follow-up interventions and data collection will be completed by the end of 2022, and the trial results are expected soon thereafter. Results will be shared at international conferences and via peer-reviewed publication.
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Objective: To conduct a capacity and needs assessment identifying important factors for the successful implementation of an oral health coach (OHC) at well-baby clinics. This Toddler Oral Health Intervention (TOHI) provides oral health promotion to parents to prevent early childhood caries. Methods: A two-round Delphi study was conducted with an expert panel consisting of OHCs and paediatric staff. The survey was based on the Consolidated Framework for Implementation Research (CFIR), consisting of 39 constructs divided over 5 domains: intervention characteristics (8), inner setting (14), outer setting (4), characteristics of individuals (5) and the process of implementation (8). Results: Constructs relating to the inner setting, outer setting and implementation process were identified as essential. Availability of resources, information on how to execute or facilitate the intervention, and the integration of the intervention into existing work tasks were also essential. Alignment and partnership between OHCs and paediatric staff, along with the prioritization of parents' and children's needs were emphasized. A formally appointed internal implementation leader within each organization, capable of transferring their enthusiasm to the team, and regular meetings for progress and experience sharing were considered essential. Conclusion: Specific strategies are needed in the implementation phase to increase the adoption, implementation and maintenance of the TOHI, ultimately leading to improved oral health in children. This study provides valuable insights into important factors for implementation of an oral health intervention in a public health setting.
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