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 usi...

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Autores principales:	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
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/54bec612c3f34f7db2fbb467ac8f17f1
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spelling	oai:doaj.org-article:54bec612c3f34f7db2fbb467ac8f17f12021-12-02T13:57:25ZImpact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial10.1038/s41598-021-81112-y2045-2322https://doaj.org/article/54bec612c3f34f7db2fbb467ac8f17f12021-01-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-81112-yhttps://doaj.org/toc/2045-2322Abstract 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).Elzbieta PaszynskaMalgorzata PawinskaMaria GawriolekInga KaminskaJustyna Otulakowska-SkrzynskaGrazyna Marczuk-KoladaSzymon RzatowskiKatarzyna SokolowskaAneta OlszewskaUlrich SchlagenhaufTheodor W. MayBennett T. AmaechiElzbieta Luczaj-CepowiczNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-15 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q 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 Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial
description	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).
format	article
author	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
author_facet	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
author_sort	Elzbieta Paszynska
title	Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial
title_short	Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial
title_full	Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial
title_fullStr	Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial
title_full_unstemmed	Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial
title_sort	impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/54bec612c3f34f7db2fbb467ac8f17f1
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Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial

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