Details

Autor(en) / Beteiligte

• Paszynska, Elzbieta
• Pawinska, Malgorzata
• Enax, Joachim
• Meyer, Frederic
• Schulze Zur Wiesche, Erik
• May, Theodor W
• Amaechi, Bennett T
• Limeback, Hardy
• Hernik, Amadeusz
• Otulakowska-Skrzynska, Justyna
• Krahel, Anna
• Kaminska, Inga
• Lapinska-Antonczuk, Joanna
• Stokowska, Ewa
• Gawriolek, Maria

Titel

Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial

Ist Teil von

• Frontiers in public health, 2023-07, Vol.11, p.1199728-1199728

Ort / Verlag

Switzerland: Frontiers Media S.A

Erscheinungsjahr

2023

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• Dental caries is a worldwide challenge for public health. The aim of this 18-month double-blinded, randomized, clinical trial was to compare the caries-preventing effect of a fluoride-free, hydroxyapatite toothpaste (test) and a toothpaste with sodium fluoride (1450 ppm fluoride; positive control) in adults. The primary endpoint was the percentage of subjects showing no increase in overall Decayed Missing Filled Surfaces (DMFS) index. The study was designed as non-inferiority trial. Non-inferiority was claimed if the upper limit of the exact one-sided 95% confidence interval for the difference of the primary endpoint DMFS between test and control toothpaste was less than the predefined margin of non-inferiority (Δ ≤ 20%). In total, 189 adults were included in the intention-to-treat (ITT) analysis; 171 subjects finished the study per protocol (PP). According to the PP analysis, no increase in DMFS index was observed in 89.3% of subjects of the hydroxyapatite group and 87.4% of the subjects of the fluoride group. The hydroxyapatite toothpaste was not statistically inferior to a fluoride toothpaste with regard to the primary endpoint. Hydroxyapatite was proven to be a safe and efficient anticaries agent in oral care. NCT04756557.