Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 18, 2022
Date Accepted: Jun 9, 2022
An Oral Health Coach at Well-baby Clinics to Promote Oral Health in Preschool Children From First Erupted Teeth: a Study Protocol for a Multi-site Pragmatic Randomized Controlled Trial
ABSTRACT
Background:
Early childhood caries is considered one of the most prevalent diseases in childhood, affecting almost half of preschool children globally. In the Netherlands, approximately one-third of five-year-olds 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 (TOHI) as an add-on have a reduced cumulative caries incidence caries and incidence density at the age of 48 months.
Methods:
This pragmatic two-arm individually randomized controlled trial (RCT) will be conducted in the Netherlands and has been approved by the Medical Ethics Research Board of UMC Utrecht. Parents with children aged 6-12 months attending one of the nine selected well baby-clinics (WBCs) were invited to participate in this pragmatic RCT. Eligible were healthy children, not requiring any form of specialized healthcare, with parents that had sufficient command of the Dutch language and had no plans to move outside the WBC region. Both groups will receive conventional oral health education in WBCs during regular WBC visits between 6-48 months. After concealed random allocation of interventions, the intervention group also will receive the TOHI from an OHC. The TOHI combines behavioral interventions of proven effectiveness in caries prevention. Data will be collected at baseline, at 24 months and 48 months. The primary study endpoint is cumulative caries incidence for children of 48 months old, and will be analyzed according to the intention-to-treat principle. For children aged 48 months, the balance between costs and effects of TOHI will be evaluated, and when they are 24 months the effects of TOHI on behavioral determinants alongside and cumulative caries incidence will be compared.
Results:
The first parent-child dyads were enrolled in June 2017, and recruitment was finished in June 2019 with 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 and will be shared at international conferences and via peer-reviewed publication. Clinical Trial: The Netherlands Trial Register: NL8737. https://www.trialregister.nl/
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