Summary
This protocol describes a pragmatic, multisite randomised controlled trial testing whether a structured Toddler Oral Health Intervention delivered by oral health coaches in well-baby clinics reduces caries incidence in children aged 6–48 months, compared to conventional oral health education alone. The intervention combines behavioural strategies of established effectiveness and will be evaluated for both clinical efficacy and cost-effectiveness. The study addresses the substantial public health burden of early childhood caries, which affects approximately one-third of Dutch 5-year-olds and nearly half of preschool-age children globally.
Regional applicability
The findings may be relevant to UK primary care and health visiting services, particularly where oral health screening and prevention are integrated into child health surveillance. The pragmatic design and well-baby clinic setting align with NHS early intervention pathways, though implementation would require adaptation to UK dental systems and language.
Key measures
Cumulative caries incidence at 48 months; caries incidence density; cost-effectiveness ratio; intermediate effects at 24 months
Outcomes reported
The study measured cumulative caries incidence and caries incidence density at 48 months in preschool children receiving an oral health coaching intervention versus usual care. Secondary outcomes included cost-effectiveness analysis and intermediate effects at 24 months.
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