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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Abductive thematic analysis blends empirical observations with theoretical frameworks, fostering a continuous and dynamic exchange between research evidence and theory. It is distinct from other forms of analysis as it is underpinned by pragmatism and is flexible in its adoption of theory to best answer the research question. As a result of an interplay between theory and data, a surprising, puzzling, or anomalous finding may lead to new insights. This flexible approach to inquiry can draw from theories dependent upon what is best able to explain the data. This results in a theoretically informed explanation for empirical phenomena, which may in turn unveil unique insights about theories, making it a valuable tool across diverse research domains in medical science. The guidelines in this paper aim to illuminate abductive thematic analysis, steering the reader through each step toward maximizing novel theoretical contributions and fostering a comprehensive understanding for researchers and educators.
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