AUTHOR=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 TITLE=Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial JOURNAL=Frontiers in Public Health VOLUME=11 YEAR=2023 URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1199728 DOI=10.3389/fpubh.2023.1199728 ISSN=2296-2565 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.