Method: Institutional review and informed consent were obtained, and adults with established extrinsic dental stain were screened and enrolled in a clinical trial. Balancing of baseline stain, subjects were randomly assigned to one of two groups: hydrogen peroxide rinse (MR) or whitening dentifrice (TP). The extent and severity of visible stain was measured on selected facial tooth surfaces by a trained examiner using the modified Lobene Index. All test products were dispensed with a manual brush in blinded kits. The MR group received a 1.5% hydrogen peroxide rinse (Crest® 3DWhite™ Multi-Care Whitening) along with a regular anticavity dentifrice, while the TP group received a whitening dentifrice (the experimental control) along with instructions for post-brushing water rinsing. Daily treatment followed marketed instructions for use, and subjects were evaluated after 7-days to assess change in extrinsic tooth stain.
Result: A total of 40 subjects were enrolled (age ranging from 19-67), groups were balanced on baseline demographics and stain levels, and 39 subjects completed the study. Both the MR & TP groups had significant (p<0.0001) stain removal after 7-days use approximating 82-93% reductions in median stain from baseline levels. At Day 7, adjusted mean (SD) Lobene composite scores were 0.28 (0.23) in the MR group and 0.63 (0.35) in the TP control, with groups differing significantly (p=0.0001) in stain removal. Stain area and intensity scores showed similar outcomes to those seen with the Lobene composite endpoint. Both treatments were well-tolerated, with 4 mild adverse events reported (1 in MR and 3 in TP).
Conclusion: In a randomized controlled trial, twice daily use of a 1.5% hydrogen peroxide rinse with routine hygiene resulted in a 93% reduction in visible extrinsic stain in a 7-day period.
Keywords: Clinical trials, Dentifrices, Mouthrinses, Oral hygiene and Stain
See more of: Dental Materials 11: Color and Appearance (Esthetics)