Method: Baseline Mean shade guide scores (Vitapan Classical) among maxillary anterior teeth were calculated for each of the consenting participants 7 days after a professional dental prophylaxis procedure. Participants were then randomly assigned to brush twice daily (morning and evening) for 1 minute each time with either the test or placebo dentifrice. Mean tooth shade guide and soft tissue examinations were repeated after 1 and 4 weeks of assigned product use. All examinations were performed under the same lighting condition and by the same examiner.
Result: Eighty voluntary participants entered the study, complied with the protocol and completed the four week clinical trial. Both study groups (test and placebo) were balanced for Vita shade guide scores and all participants had an A3 or darker mean shade score at the baseline examination. The mean tooth shade improvements after 1 and 4 weeks of product use were respectively 1.05 and 2.38 for the test group and, 0.09 and 0.23, for the placebo group. The test group demonstrated statistically significant (p<0.05) whitening improvements of 0.96 in mean tooth shade as compared to the placebo group after 1 week of product use and 2.15 after 4 weeks of product use.
Conclusion: The clinical results demonstrate that the 1% H2O2 and 0.76% sodium monofluorophosphate dentifrice provides statistically significant intrinsic tooth whitening improvements in mean shade scores as compared to a matching placebo dentifrice after 1 and 4 weeks use.