Effectiveness of fluoride varnish four times a year in preventing caries in the primary dentition: A 2 year randomized controlled trial.

Objectives: To test the effectiveness of fluoride varnish in preventing caries in early childhood in children at high risk of caries.

Basic Research Design: Randomized controlled trial.

Participants: 504 participants, with mean age of 21 months at baseline randomly allocated into a test and a control group. 427 children remained in the study after two years.

Intervention: Fluoride varnish applied four times a year, every three months. The intervention lasted for two years.

Main Outcome Measures: Dental status was recorded based on the International Caries Detection and Assessment System (ICADS).

Results: Mean dmfs was similar in the control and test groups at baseline (1.0 and 1.2 respectively) but was significantly different (10.1 and 5.2, p ⟨ 0.001, ANOVA) at endpoint. The proportion caries free in the two groups was 40% and 69.4% after two years.

Conclusions: The application of fluoride varnish four times a year prevented the incidence and reduced the severity of caries in pre-school children.

Trial Registration Number: DRKS00013980.