Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial

Elzbieta Paszynska, Malgorzata Pawinska, Maria Gawriolek, Inga Kaminska, Justyna Otulakowska-Skrzynska, Grazyna Marczuk-Kolada, Szymon Rzatowski, Katarzyna Sokolowska, Aneta Olszewska, Ulrich Schlagenhauf, Theodor W May, Bennett T Amaechi, Elzbieta Luczaj-Cepowicz, Elzbieta Paszynska, Malgorzata Pawinska, Maria Gawriolek, Inga Kaminska, Justyna Otulakowska-Skrzynska, Grazyna Marczuk-Kolada, Szymon Rzatowski, Katarzyna Sokolowska, Aneta Olszewska, Ulrich Schlagenhauf, Theodor W May, Bennett T Amaechi, Elzbieta Luczaj-Cepowicz

Abstract

The aim of this trial was to determine whether a toothpaste with microcrystalline hydroxyapatite is not inferior to a fluoride toothpaste in prevention of caries in children. This double-blinded randomized control trial compared two toothpastes regarding the occurrence of caries lesions using International Caries Detection and Assessment System (ICDAS) ≥ code 1 on the primary dentition within 336 days. The test group used a fluoride-free hydroxyapatite toothpaste three times daily while control group used a toothpaste with fluoride. 207 children were included in the intention-to-treat analysis; 177 of them finished the study per protocol. An increase in caries ICDAS ≥ code 1 per tooth was observed in 72.7% of the hydroxyapatite-group (n = 88), compared with 74.2% of the fluoride-group (n = 89). The exact one-sided upper 95% confidence limit for the difference in proportion of participants with ICDAS increase ≥ 1 (-1.4%) was 9.8%, which is below the non-inferiority margin of 20% demonstrating non-inferiority of hydroxyapatite compared to the fluoride control toothpaste. This RCT showed for the first time, that in children, the impact of the daily use of a toothpaste with microcrystalline hydroxyapatite on enamel caries progression in the primary dentition is not inferior to a fluoride control toothpaste (Clinical Trials NCT03553966).

Conflict of interest statement

The authors declare no competing interest.

Figures

Figure 1
Figure 1
Patient flow chart.
Figure 2
Figure 2
Increase in ICDAS ≥ ∆1 in the fluoride, and HAP-group. In both groups, the proportion of children who developed at least on one tooth a caries lesion of ICDAS ≥ ∆1 is not significantly different (more details are shown in Table 2).
Figure 3
Figure 3
Increase in ICDAS ≥ ∆2 in the fluoride, and HAP-group. In both groups, the proportion of children who developed at least on one tooth a caries lesion of ICDAS ≥ ∆2 is not significantly different (more details are shown in Table 4).
Figure 4
Figure 4
PCR-values from visit 2 to visit 6. A represents the HAP-group, while B shows the fluoride-group. In both groups the PCR-values decreased significantly (Friedman-test, p 

Figure 5

GI from visit 2 to…

Figure 5

GI from visit 2 to visit 6. A represents the HAP-group, while B…

Figure 5
GI from visit 2 to visit 6. A represents the HAP-group, while B shows the fluoride-group. In both groups the GI decreased significantly. There was no difference between the HAP and the fluoride-group.
Figure 5
Figure 5
GI from visit 2 to visit 6. A represents the HAP-group, while B shows the fluoride-group. In both groups the GI decreased significantly. There was no difference between the HAP and the fluoride-group.

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