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Objective: To investigate the clinical efficacy of the toothpaste containing 12 % high cleaning silica (HCS) and 2.1% sodium phytate on removing natural extrinsic dental stain.Methods: A random, double-blind and controlled clinical study was performed to compare the extrinsic stain index on the buccal surface of the teeth between test group and control group.The subjects in the test group brushed their teeth with a silica test toothpaste containing 12 % high cleaning silica (HCS) and 2.1% sodium phytate, instead of the control group with a silica control toothpaste.The extrinsic stain indexes of the subjects were measured respectively at baseline, after 1-week and 4-week according to Lobene stain index (LSI) method[1].Results: The efficacy on extrinsic stain removal of the test toothpaste was good, significant different from the control toothpaste shown in the analysis of generalized estimating equations.During the 4 weeks, the silica test toothpaste gave increasing efficacy on removing extrinsic dental stain with respect to the increasing of the days.Conclusion: A statistically significant decrease in extrinsic dental stain was clinically proven after 4 week bmshing with the test toothpaste containing HCS and sodium phytate, indicating that HCS and sodium phytate may have synergistic effect on removing extrinsic dental stain.