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


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).

SUBMITTER: Paszynska E 

PROVIDER: S-EPMC7846568 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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

Paszynska Elzbieta E   Pawinska Malgorzata M   Gawriolek Maria M   Kaminska Inga I   Otulakowska-Skrzynska Justyna J   Marczuk-Kolada Grazyna G   Rzatowski Szymon S   Sokolowska Katarzyna K   Olszewska Aneta A   Schlagenhauf Ulrich U   May Theodor W TW   Amaechi Bennett T BT   Luczaj-Cepowicz Elzbieta E  

Scientific reports 20210129 1


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  ...[more]

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