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

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.

Epidemiological analysis of dental caries in 12-year-old children residing in urban and rural settings in the Podlaskie region of north-eastern Poland.

INTRODUCTION: Dental caries is still a social problem in many countries, including Poland. Through epidemiological studies conducted in index groups among children and adults, it is possible to monitor its progress and take appropriate action. The Podlaskie region is an area where the severity of dental caries in children has been the highest in the country for a few years, both in urban and rural settings. OBJECTIVE: Evaluation and comparison of indicators of the progress of caries--Decayed Missing Filled Teeth (DMFT)--in 12-year-olds from the urban and rural areas of north-eastern Poland, measured between 2003-2010. MATERIALS AND METHOD: In 2003 and 2010, respectively, 445 children were examined: in 2003--188: 101 boys, 87 girls; 98 from urban areas, 90 from rural areas, and in 2010--257 adolescents: 134 boys, 123 girls; 157 from urban areas and 70 from rural areas. The study protocol was strictly subordinated to the WHO study monitor guidelines. DMFT indices were evaluated in particular years. The distribution of their individual components was then compared and analyzed. The outcomes resulting from the place of residence and gender of the adolescents were taken into account. In the statistical analysis, Shapiro-Wilk test and Mann-Whitney U test were used. RESULTS: In 2003, the mean value of DMFT was 4.76, and in 2010 it decreased to 3.36 (p<0.0001). In 2003, DMFT was 4.42 in the rural areas, and after 7 years it has risen to 4.77. There was a significant decrease in the value of the index (from 5.08 to 2.82, p<0.0001) in the urban areas. No significant differences based on gender were observed between these years. CONCLUSIONS: The values of caries intensity among 12-year-olds from the Podlaskie region, both in rural and urban areas, are still high. Among children from the rural areas, dental caries progression is more visible and has not improved during the years 2003-2010. These findings should lead to the development of programmes for the inhabitants of rural areas.