This study was carried out on 40 health adults, 20 to 29 years of age, using an experimental-control group study with double blind test. The experimental group used dentifrice containing 1.5% calcium peroxide and 1.3% sodium bicarbonate, while the control group used calcium peroxide and sodium bicarbonate free dentifrice for 12 weeks. All other ingredients were the same in both groups. On the 1st, 2nd, 4th, 8th and 12th weeks, in the first test, the subjects measured color by naked eye and a machine. On the 1st, 2nd, 4th and 6th weeks, three examiners measured color by eye and received the results of the second test. There were no statistically significant differences between the experimental group and control group on growth of fungus including Candida albicans in the oral cavity nor in the baseline results between before and after using dentifrice followed by using for an increasing period of time. There was no statistically significant difference in the result of caries activity tests using RD test®. In addition, there was no statistically significant difference in the baseline results between the experimental and control groups. There was no statistically significant difference in gingivitis index baseline results between the experimental post-test change of plaque index, the experimental group showed statistically significant reduction of plaque amount in two weeks compared with that in the control group(p<0.05), but generally there was no obvious effect on plaque accumulation. When this study compared baseline data with the results of post-test, there was no statistically significant difference in the control group, but there was a significant reduction from the second week in the experimental group.
From these clinical trial results, when subjects used whitening dentifrice containing 1.5% calcium peroxide agent for 3 months, there were neither side effects of fungus change nor gingival inflammation change in the oral cavity.