Table 3.8: Adverse events in clinical trials with toothpastes containing up to 3% hydrogen peroxide (unpublished company data)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
Related publication:
Other Figures & Tables on this publication:
Table 3.1: Summary of in vitro genotoxicity of hydrogen peroxide (IARC, 1999)
Table 3.2. Summary of in vivo genotoxicity of hydrogen peroxide (ECB, 2003)
Table 3.3. Incidence of gastro-duodenal lesions in C57BL/6J mice after receiving hydrogen peroxide in the drinking water (Ito et al., 1981)
Table 3.4. Incidence of duodenal tumours in 4 strains of female mice treated with 0.4% H2O2 in drinking water (Ito et al., 1984)
Table 3.5. Effect on gastro-duodenal carcinogenesis induced by MNNG (Takahashi et al, 1986)
Table 3.6: Hydrogen peroxide exposure in mouse dermal and hamster check pouch tumour promotion assays following initiation by with DMBA
Table 3.7: Summary of clinical studies using hydrogen peroxide toothpastes
Table 3.8: Adverse events in clinical trials with toothpastes containing up to 3% hydrogen peroxide (unpublished company data)
Table 3.9: Unfavourable reports received to marketed toothpaste with 0.75% hydrogen peroxide in the period 1995-1997(unpublished company data)
Table 3.10: Summary of human safety data of hydrogen peroxide in mouth-rinses
Table 3.11: Unfavourable reports received to marketed mouth-rinse with 0.75% hydrogen peroxide in the period 1995-1997 (unpublished company data)
Table 3.12. Available hydrogen peroxide in the saliva during the first 30 and 60 minutes
Table 3.13. Concentration of hydrogen peroxide in the strip, at the teeth, at the gingival, and in the saliva during the first 60 minutes.
