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

• Published in: Frontiers in public health Vol. 11; p. 1199728
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Switzerland Frontiers Media S.A 18.07.2023
• Subjects: Adult; adults; Cariostatic Agents - therapeutic use; dental caries; Dental Caries - prevention & control; Dental Caries Susceptibility; Durapatite; fluoride; Fluorides - therapeutic use; Humans; Public Health; randomized clinical trial (RCT); toothpaste; Toothpastes - therapeutic use; dental caries; hydroxyapatite; randomized clinical trial (RCT); toothpaste; adults; fluoride; Decayed Missing Filled Surfaces (DMFS) index; public health
• ISSN: 2296-2565; 2296-2565
• DOI: 10.3389/fpubh.2023.1199728

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.