A Randomized Controlled Trial to Evaluate and Compare the Effectiveness of Two Fluoride Varnishes Containing Casein Phosphopeptide-Amorphous Calcium Phosphate and Xylitol with Brushing Twice Daily Regimen in Preventing Dental Caries among 3-6-year-old Preschool Children.

BACKGROUND: Early childhood caries (ECC) is a rapidly progressing condition in preschool children. While fluoride is the gold standard for caries prevention, adjuncts like casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and xylitol may enhance its effectiveness in preventing dental caries. AIM: To compare the effectiveness of fluoride varnishes containing CPP-ACP and another xylitol vs brushing with fluoridated toothpaste in preventing caries among preschool children. MATERIALS AND METHODS: A three-arm randomized controlled trial was conducted among 60 children aged 3-6 years. Group I received Enamelast™ (fluoride + xylitol) varnish with brushing, group II received MI Varnish™ (fluoride + CPP-ACP) with brushing, and group III followed brushing with fluoridated toothpaste only. Varnishes were applied at baseline and 6 months. The caries increment [decayed, missing, and filled surfaces in primary teeth/permanent teeth (dmfs/DMFS)] was evaluated at baseline, 6 months, and 12 months. RESULTS: At 12 months, both varnish groups showed significantly lower caries increments than brushing alone (p < 0.001). Group II (MI Varnish™) showed the slowest progression (slope β = 0.025), followed by group I (β = 0.08), while group III (brushing only) had the fastest progression (β = 0.12). No significant difference was found between varnish groups (p = 0.882). CONCLUSION: Both varnishes were superior to brushing alone in preventing ECC, with MI Varnish™ demonstrating the slowest progression. Fluoride varnishes, particularly when combined with remineralizing agents, provide effective adjunctive strategies for caries prevention in preschool children. CLINICAL SIGNIFICANCE: Fluoride varnishes with CPP-ACP or xylitol were more effective than brushing alone in reducing ECC. Though MI Varnish™ (CPP-ACP) showed the slowest progression, the difference between varnishes was not significant. HOW TO CITE THIS ARTICLE: Salam J, Pandit IK, Gugnani N, et al. A Randomized Controlled Trial to Evaluate and Compare the Effectiveness of Two Fluoride Varnishes Containing Casein Phosphopeptide-Amorphous Calcium Phosphate and Xylitol with Brushing Twice Daily Regimen in Preventing Dental Caries among 3-6-year-old Preschool Children. Int J Clin Pediatr Dent 2026;19(8):1041-1046.