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

UNLABELLED: <p>

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 randomized 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. </p>.