Effective Prevention of Early Childhood Caries in Well-Baby Clinics: Results of a Pragmatic Randomised Trial.

Abstract

Introduction: This study evaluated the Toddler Oral Health Intervention (TOHI) for preventing early childhood caries (ECC) by 48 months. TOHI, an add-on to standard care in well-baby clinics (WBCs), aims to reduce ECC incidence and severity.

Methods: Dyads were randomised into TOHI (added to care as usual) or care as usual (CAU). The primary outcome was ECC (incidence and severity); secondary outcomes included plaque and pufa scores, and oral health behaviour changes. TOHI combined Non-Operative Caries Treatment and Prevention, Motivational Interviewing, and the Health Action Process Approach. Oral health coaches applied TOHI from enrolment (age 6-12 months) to 48 months. Data were collected at baseline, 24, and 48 months through questionnaires and clinical assessments. Blinding was maintained for clinical assessment and analysis. Intention-to-treat analysis used a Negative Binomial Hurdle Model with one-sided statistical testing.

Results: Of the 402 enrolled dyads, 353 (88%) completed the study (TOHI: 176/205, 86%; CAU: 177/197, 90%). At 48 months, 61% of TOHI toddlers and 54% of CAU toddlers remained free of any caries lesions (ICDAS ≥1). Among toddlers with caries, TOHI reduced dmfs scores by 40% (RR: 0.60; UL95% CI: 0.98, p = 0.04). For cavitated lesions (ICDAS ≥3), TOHI reduced dmfs scores by 53% (RR: 0.47; UL95% CI: 1.04, p = 0.06), and 84% of TOHI toddlers remained free of cavitated lesions versus 78% in CAU.

Conclusion: TOHI, added to usual care at WBCs, modestly reduced ECC incidence and severity at 48 months. Further research is needed to assess long-term impacts and cost-effectiveness.