Effect of probiotic supplementation on the progression of non-cavitated carious lesions in children: A 12-month randomized controlled trial.

Probiotic supplementation reduced the proportion of children whose caries progressed to cavitated lesions compared to control.

• Progression to cavitated lesions (ICDAS 5-6) occurred in 26.8% of children in the probiotic group (33/123) versus 46.3% in the control group (38/82).
• The study used a double-blind, placebo-controlled, cluster-randomized design with 10 public nursery schools in Santiago, Chile.
• Children were aged 2-3 years and examinations were conducted at baseline and 12 months using ICDAS criteria.

The intervention involved daily consumption of Lactobacillus rhamnosus SP1-supplemented milk at a dose of 1 × 10^7 CFU/mL for 10 months.

• A total of 205 children were randomized by nursery school clusters in a 1:1 ratio to receive either probiotic-supplemented milk or standard milk once daily.
• The supplementation period was 10 months, while the total follow-up period was 12 months.
• Adherence to the intervention exceeded 80%.

No intervention-related adverse events were observed during the trial.

• The trial was reported as safe with no adverse events attributable to the probiotic supplementation.
• The authors describe the intervention as 'a safe and feasible adjunct for community-based prevention of early childhood caries.'

Surface-level caries transitions were minimal in both groups.

• Surface-level transitions were minimal in both the probiotic and control groups.
• Surface-level data are reported descriptively rather than as a primary inferential outcome.
• The primary outcome was defined at the child level as proportion progressing to cavitated lesions (ICDAS 5-6).

The trial was conducted in a community-based setting using cluster randomization by nursery school.

• Ten public nursery schools in Santiago, Chile served as the clusters.
• Cluster randomization was performed at a 1:1 ratio.
• The trial was prospectively registered at ClinicalTrials.gov (NCT01648075).