Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial
| Autor: | Małgorzata Pawińska, Szymon Rzatowski, Katarzyna Sokołowska, Theodor W. May, Elzbieta Luczaj-Cepowicz, Justyna Otulakowska-Skrzynska, Maria Gawriolek, Inga Kaminska, Ulrich Schlagenhauf, Elzbieta Paszynska, Aneta Olszewska, Bennett T. Amaechi, Grażyna Marczuk-Kolada |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Male business.product_category Test group Science Dentistry Diseases Dental Caries Article law.invention 03 medical and health sciences chemistry.chemical_compound Fluorides 0302 clinical medicine Medical research Randomized controlled trial Double-Blind Method law medicine Humans Child Multidisciplinary Toothpaste Dentition business.industry 030206 dentistry medicine.disease Clinical trial 030104 developmental biology Microcrystalline Durapatite chemistry Child Preschool Medicine Female business Fluoride Early childhood caries Toothpastes |
| Zdroj: | Scientific Reports Scientific Reports, Vol 11, Iss 1, Pp 1-15 (2021) |
| ISSN: | 2045-2322 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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