To study the effects of prolonged and exclusive breast-feeding on dental caries, we followed up children participating in the Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster-randomized trial of a breast-feeding promotion intervention based on the WHO/UNICEF Baby-Friendly Hospital Initiative. A total of 17,046 healthy, mother-infant breast-feeding pairs were enrolled from 31 Belarussian maternity hospitals and affiliated polyclinics, of whom 13,889 (81.5%) were followed up at 6.5 years. At follow-up, polyclinic pediatricians transcribed the reports of a standard dental examination performed by public health dentists at age 6 years and recorded in the children’s polyclinic charts. Analysis was based on intention to treat, with a statistical model that accounts for clustering within hospitals/clinics to permit inferences at the individual level. The experimental intervention led to a large increase in exclusive breast-feeding at 3 months (43.3 vs. 6.4%, p < 0.001) and a significantly higher prevalence of any breast-feeding at all ages up to and including 12 months. No significant intervention effects were observed on dental caries. Our results, based on the largest randomized trial ever conducted in the area of human lactation, provide no evidence of beneficial or harmful effects of prolonged and exclusive breast-feeding on dental caries at early school age.

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