Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial
Elżbieta Paszyńska, M Pawińska, Joachim Enax, Frederic Meyer, Erik Schulze zur Wiesche, Theodor W. May, Bennett T. Amaechi, Hardy Limeback, Amadeusz Hernik, Justyna Otulakowska-Skrzyńska, Anna Krahel, Inga Kamińska, Joanna Łapińska-Antończuk, Ewa Stokowska, Maria Gawriołek
Abstract
Background: 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. Methods: 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%). Results: 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. Conclusion: Hydroxyapatite was proven to be a safe and efficient anticaries agent in oral care. Clinical trial registration: NCT04756557.