Author:
Paszynska Elzbieta,Pawinska Malgorzata,Gawriolek Maria,Kaminska Inga,Otulakowska-Skrzynska Justyna,Marczuk-Kolada Grazyna,Rzatowski Szymon,Sokolowska Katarzyna,Olszewska Aneta,Schlagenhauf Ulrich,May Theodor W.,Amaechi Bennett T.,Luczaj-Cepowicz Elzbieta
Abstract
AbstractThe 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).
Funder
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Uniwersytet Medyczny w Bialymstoku
Dr. Kurt Wolff GmbH
Publisher
Springer Science and Business Media LLC
Cited by
42 articles.
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