3.4.2. Confirmative statistical test (primary analysis) and additional statistical tests
DMFS
REGRESSION
The primary efficacy endpoint was the percentage of subjects showing no increase in DMFS Index (ΔDMFS = DMFS Percentage of subjects without an increase of DMFS Index in the PP and ITT population.ΔDMFS%With ΔDMFS%ΔDMFS%The upper limit of the one-sided 95% confidence interval for the difference in percentage of subjects without an increase of DMFS (ΔDMFS%In addition, a logistic regression analysis was performed with the primary endpoint (increase in DMFS vs. no increase in DMFS) as dependent variable and toothpaste, center, sex, and age as independent variables (covariates).The results for the PP population confirmed that the “risk” of an increase in DMFS did not differ significantly between control and test toothpastes.Furthermore, the risk of an increase in DMFS did not differ significantly between centers, was not dependent on age, but was significantly higher in men compared to women. The corresponding odds ratio revealed that the “risk” of an increase in DMFS was 4.7-fold higher in men: An increase in DMFS was observed in 13 of 57 (22.8%) men and only in 7 of 114 (6.1%) women of the PP population.