Table 3.
Development of enamel caries lesions with ICDAS code ≥ 1 or the progression of an existing enamel caries lesion by at least one ICDAS code in the ITT-population and confidence intervals for the “risk difference”.
| ITT-population | Treatment/toothpaste | |||||
|---|---|---|---|---|---|---|
| HAP (test) | Fluoride (control) | Total | ||||
| n | % (column) | n | % (column) | n | % (column) | |
| ICDAS increase ≥ 1 per tooth | ||||||
| No | 26 | 25.2% | 26 | 25.0% | 52 | 25.1% |
| Yes | 77 | 74.8% | 78 | 75.0% | 155 | 74.9% |
| Total | 103 | 100.0% | 104 | 100.0% | 207 | 100.0% |
| Primary endpoints | Population | Difference HAP-fluoride | Lower CI95% one-sided | Upper CI95% one-sided | Lower CI95% two-sided | Upper CI95% two-sided |
|---|---|---|---|---|---|---|
| Confidence intervals for the “risk difference” HAP-Fluoride | ||||||
| ICDAS increase ≥ 1 per tooth (Version 1) | ITT | − 0.2% | − 10.2% | 9.7% | − 12.1% | 11.6% |
CI95%, confidence interval; ITT, intent-to-treat; HAP, hydroxyapatite.