Comparing Silica-Enriched and Fluoride Toothpastes for Teeth with Enamel Defects: Findings from a Clinical Trial

Published 14 September 2026
Reviewed by Dr. Advaitha Anand, BDS MDS (Conservative Dentistry & Endodontics)

Molar-Incisor Hypomineralisation (MIH) is a condition in which tooth enamel forms with reduced mineral density, leaving affected teeth unusually soft, sensitive, or prone to damage. Researchers recently conducted a clinical trial to evaluate whether a special silica-enriched remineralizing toothpaste (REFIX Booster) could improve mineral content in teeth affected by MIH compared to standard toothpaste containing 1,450 parts per million (ppm) fluoride.

How the Study Was Designed

The study was structured as a triple-blind, parallel-group, exploratory pilot randomized clinical trial. In a triple-blind study, neither the child, the clinicians, nor the data analysts know which toothpaste each participant is assigned to use, helping to eliminate bias.

The trial enrolled 30 children aged 6 to 12 years who had fully erupted permanent front teeth (incisors) affected by MIH. A total of 95 affected teeth were evaluated across all participants. The children were randomly assigned to two groups:

The intervention group (14 children) used the silica-enriched remineralizing toothpaste.
The control group (16 children) used standard 1,450-ppm fluoride toothpaste.

At the beginning of the trial, all children received professional prophylaxis—a thorough professional dental cleaning—and were provided with a 45-day home-use kit.

To measure mineral changes in the enamel, the researchers used Quantitative Light-induced Fluorescence (QLF), a non-invasive optical method that measures changes in tooth mineral levels using light fluorescence. QLF parameters, labeled as ΔF (%) and ΔFmax (%), were assessed at four time points: baseline (before use), 5 minutes after first use, 1 hour after first use, and after 45 days of regular home use. Data were analyzed using maximum-likelihood linear mixed-effects models along with complementary statistical tests, including Mann-Whitney U, chi-square or Fisher exact tests, and baseline-adjusted ANCOVA.

The study also measured tooth pain sensitivity using a Visual Analogue Scale (VAS)—a tool where patients rate symptom intensity—as well as aesthetic perception and any reported adverse effects.

What the Trial Found

After 45 days of home use, the QLF evaluations showed no statistically significant difference in enamel mineral gain between the silica-enriched toothpaste and standard fluoride toothpaste:

Mineral Change Parameter (ΔF): At 45 days, ΔF was -2.74% in the silica-enriched group and -4.46% in the standard fluoride group. The calculated difference between the two groups in change from baseline was -0.43 (95% confidence interval, -2.73 to 1.86), which was not statistically significant (p = 0.711).
Maximum Mineral Change Parameter (ΔFmax): At 45 days, ΔFmax was -4.27% in the silica-enriched group and -7.45% in the control group. The group difference was -0.78 (95% confidence interval, -5.08 to 3.52), which was also not statistically significant (p = 0.723).

However, the study found a statistically significant benefit regarding tooth pain. Children using the silica-enriched toothpaste experienced a greater reduction in sensitivity visual analogue scale scores compared to those in the standard fluoride group (p = 0.011).

There were no relevant differences between the groups regarding aesthetic perception, and no adverse effects were reported throughout the 45-day study.

Limitations of the Research

When reviewing these results, several limitations must be considered:

Small Participant Group: As a pilot exploratory study, the trial included only 30 children and 95 affected teeth, with 14 children in the test group and 16 in the control group.
Short Follow-Up Time: The trial evaluated outcomes over 45 days; longer-term effects on mineral gain or sensitivity beyond this timeframe were not measured.
Specific Age Range and Tooth Types: The study evaluated only children aged 6 to 12 years with fully erupted permanent incisors affected by MIH.

What This Means for Patients

For children with Molar-Incisor Hypomineralisation, standard fluoride toothpaste remains an established daily option for routine care. While the silica-enriched toothpaste tested in this study did not provide greater enamel mineral gain than standard fluoride toothpaste over 45 days, it demonstrated a meaningful reduction in tooth pain sensitivity. Parents and patients managing sensitive or mineral-deficient teeth should consult their dentist to determine the best choice of toothpaste and preventive care for their individual circumstances.