Table 3.7: Summary of clinical studies using hydrogen peroxide toothpastes
| Formulation |
n |
Dosage |
Safety findings |
| *unpublished company data |
| 0.5% Calcium peroxide toothpaste |
25 subjects |
applied 4 times a day for 10 days, then 14 days rest and then applied twice on day 25 |
No adverse events in treatment group* |
| 0.5% Calcium peroxide toothpaste |
232 subjects |
daily brushing for 7 weeks |
Examination at 2, 5 and 7 weeks showed no treatment-related effects* |
| Sodium percarbonate toothpaste (0.75% H2O2) |
74 subjects |
6 months |
Transient angular cheilitis in one subject* |
| toothpaste (0.75% H2O2) |
100 subjects |
3 months |
No product-related findings* |
| 0.75% H2O2 with 5% NaHCO3 toothpaste |
25 patients |
twice daily brushing for 28 days after maxillary flap Gingival surgery (bilateral- double-blind cross over study) |
No unwanted effects reported.
75% of patients preferred test product to control (Dentino et al., 1995) |
| 0.75% H2O2 with 5% NaHCO3 toothpaste |
62 subjects + 21 controls |
twice daily brushing for 6 months |
Oral lesions reported in 3 treated patients and 4 controls (Fischman et al., 1992) |
| 0.75% H2O2 toothpaste |
71 subjects |
3 weeks |
An adverse effect was reported by one subject in the treatment group and one control* |
| 0.75% and 1.5% H2O2 toothpaste |
293 subjects |
3 weeks |
24 reports of oral lesions in the active treatment groups; 46 reports in the control group*
5 reports in each of the treated and control groups*
No soft tissue changes associated with either test or control product (Fischman et al. [Abstract], 1992b) |
| 0.75% H2O2 toothpaste |
279 subjects |
|
|
| 1.5% H2O2 with 10% NaHCO3 toothpaste |
60 subjects + 20 controls |
twice daily brushing for 6 months |
|
Source:
SCCP
Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products (2007), p.41-42
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.
