Evaluation of the effect of a silica-enriched toothpaste on teeth with MIH: A triple-blind pilot randomized controlled clinical trial.

OBJECTIVES: To evaluate the effect of a silica-enriched remineralizing toothpaste on mineral gain in MIH-affected teeth using quantitative light-induced fluorescence (QLF). Secondary outcomes were pain sensitivity, aesthetic perception, and adverse effects after 45 days of home use. METHODS: This triple-blind, parallel-group, exploratory pilot randomized clinical trial allocated children aged 6-12 years with fully erupted MIH-affected permanent incisors to REFIX® Booster toothpaste or standard 1450-ppm fluoride toothpaste. Both groups received professional prophylaxis and a 45-day home-use kit. QLF parameters ΔF (%) and ΔFmax (%) were assessed at baseline, 5 minutes, 1 hour, and 45 days. The primary analysis used maximum-likelihood linear mixed-effects models accounting for repeated measures and clustering of teeth within participants. Mann-Whitney U, chi-square or Fisher exact tests, and baseline-adjusted ANCOVA were used for complementary analyses. RESULTS: Thirty children were randomized (intervention: n=14; control: n=16), comprising 95 teeth. At 45 days, ΔF was -2.74% in the intervention group and -4.46% in the control group, with no significant between-group difference in change from baseline (-0.43; 95% CI, -2.73 to 1.86; p=0.711). ΔFmax was -4.27% and -7.45%, respectively, also with no significant difference (-0.78; 95% CI, -5.08 to 3.52; p=0.723). Sensitivity visual analogue scale scores decreased more in the intervention group (p=0.011). No relevant differences in aesthetic perception and no adverse effects were reported. CONCLUSIONS: The silica-enriched toothpaste was not superior to standard fluoride toothpaste for QLF-assessed mineral gain, but showed a promising reduction in pain sensitivity. CLINICAL SIGNIFICANCE: The silica-enriched remineralizing toothpaste demonstrated a statistically significant reduction in pain sensitivity in MIH-affected teeth after 45 days of home use, with no adverse effects reported. These findings support its potential as a safe, non-invasive, patient-centered adjunct for managing hypersensitivity in children with molar-incisor hypomineralization. TRIAL REGISTRATION: ReBEC, RBR-6d3g5hp; UTN: U1111-1327-7119.