Table 3.8: Adverse events in clinical trials with toothpastes containing up to 3% hydrogen peroxide (unpublished company data)
Duration |
No. subjects/cell |
Level of H2O2 in toothpastes (%) |
Adverse events |
6 months |
100 |
3, 0.75, 0 |
No product related adverse events |
6 months |
65 |
3, 0.75, 0 |
1 subject using the 0% peroxide toothpaste suffered tooth sensitivity for one week |
21 days |
40 |
1.5, 0 |
No product related adverse events |
21 days |
34 |
1.5, 0 |
No product related adverse events |
48 hours |
15 |
1.5, 0.75 |
No product related adverse events |
21 days |
50 |
3, 1.5 |
No product related adverse events |
1 month |
29 |
1.5 |
No product related adverse events |
2 months |
17 |
1.5, 0 |
No product related adverse events |
Source:
SCCP
Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products (2007), p.42
|