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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*unpublished company data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