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

BackgroundDental 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.MethodsThe 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%).ResultsIn 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.ConclusionHydroxyapatite was proven to be a safe and efficient anticaries agent in oral care.Clinical trial registrationNCT04756557

Stress/Immune Biomarkers in Saliva among Children with ADHD Status

Background. This cross-sectional study aimed to evaluate stress and immune biomarkers in saliva samples of attention-deficit/hyperactivity disorder ADHD compared to healthy non-ADHD children. Material and methods. A total of 132 children under 11 years old (8.5 ± 1.1) enrolled in a cross-sectional study: with confirmed ADHD (n = 60) and healthy controls (n = 72). The clinical evaluation included physical measurements (height, waist, hip circumference, body weight, body mass index BMI, BMI z-score) and unstimulated saliva collection and measurements of free cortisol, salivary alpha-amylase (sAA), and secreted immunoglobulins (sIgA, IgG, and IgM) with quantitative assay (ELISA) analysis. Unpaired t-test, Welch test, or Mann–Whitney U test were applied for group comparisons when appropriate, and the correlation between variables was analyzed with Spearman’s rank coefficient. Results were considered significant at p < 0.05. Results. In the ADHD group, body weight (p ≤ 0.01), BMI (p ≤ 0.009), and hip circumference (p ≤ 0.001) significantly differed, while waist size and BMI z-score did not (p > 0.05). Significant elevation of the salivary sAA (p = 0.03), sIgA (p = 0.02), and IgM (p ≤ 0.001) biomarkers were detected, without differences in the morning cortisol (p > 0.05). Significant correlations between cortisol and BMI, hip size, and IgA, as well as between IgG and sAA and IgA were obtained. Conclusions. Saliva can be used to monitor ADHD status with regard to biomarkers indicating the hypothalamus–pituitary–adrenal axis, as HPA axis, and sympathetic activity. The results indicate that morning collection of saliva in contrast to unchanged salivary cortisol, may evaluate mentioned above system dysregulations by measurements of sAA and immunoglobulins among ADHD children

Image_1_Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial.JPEG

BackgroundDental 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.MethodsThe 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%).ResultsIn 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.ConclusionHydroxyapatite was proven to be a safe and efficient anticaries agent in oral care.Clinical trial registrationNCT04756557.</p