Caries prevention with 1000-ppm fluoride toothpaste in preschool children: a 24-month cluster-randomized controlled trial

Objective: To evaluate the efficacy of toothpaste containing 1000 ppm fluoride in preventing dental caries in primary teeth of preschool children. Methods: A 24-month cluster-randomized controlled trial was conducted in kindergartens in Shenzhen, China. Children, aged 3–4 years, allocated to the test group received a sodium-fluoride toothpaste labelled as containing 1000 ppm F for home use, whereas children in control kindergartens did not receive the study toothpaste and continued to use their usual toothpaste. Caries was assessed according to World Health Organization criteria, essentially at the cavitation level. The primary outcomes were the 24-month increments in dmft and dmfs index scores Results: A total of 514 children completed the trial. The test group showed significantly lower mean dmft and dmfs increments than the control group after two years (2.6 vs. 3.3; 5.2 vs. 6.4, P < 0.05). Among the children with caries at baseline, caries increment was significantly lower in the test group compared with control group (3.1 vs 4.5 for dmft and 7.2 vs 10.0 for dmfs. P < 0.001), while no significant difference was found in children with no caries at baseline. Oral health related behaviors were comparable between groups. Conclusion: Daily use of 1000-ppm fluoride toothpaste reduces caries increment in primary teeth, particularly in caries-active preschool children. Clinical significance: 1000-ppm fluoride toothpaste is recommended for preschoolers at high caries risk residing in non-fluoridated water areas, alongside with oral health behavioural interventions such as adoption of toothbrushing twice a day.