Objective: This study was designed to evaluate the effects on intrinsic tooth color of a 10% carbamide peroxide pre-dosed strip (Aquafresh Pure WhiteŽ) versus brushing alone. Methods: This was a randomized, controlled, parallel group and examiner-blind study. Normal, healthy subjects with a Vita shade of A-3 or greater on 2 of the 4 maxillary incisors based on a Vita Shade Guide value-oriented scale were enrolled. Seventy-six (76) subjects were randomly assigned to 1 of 2 treatment regimens and treated for 14 days (38 w/Experimental whitening strips/brushing and 38 w/Brushing only). Whitening strips were used twice daily for one half hour each time. All subjects brushed with Aquafresh Fluoride Protection twice daily with the toothbrush provided. In order to follow the change in intrinsic tooth color and to evaluate safety (including tooth sensitivity), oral examinations were conducted at screening/baseline, and after 7, 10 and 14 days of treatment. The Cochran-Mantel-Haenszel Test, (using modified ridit scores), stratified for smoking status (smoker and non-smoker) was used to make all treatment comparisons. Results: The whitening strip group experienced a 3.0 shade, a 4.4 shade and a 5.0 shade greater reduction from baseline tooth shade than the group assigned to toothbrushing alone at Day 8, Day 11 and Day 15, respectively (all p-values <0.0001). During the post-baseline period, 4 or 10.8% of subjects reported treatment-emergent tooth sensitivity in the whitening strip group. Six or 16.2% of subjects experienced treatment-emergent mild oral soft tissue adverse events. Conclusion: This study demonstrates that an experimental strip, predosed with 10% carbamide peroxide, is efficacious in the treatment of intrinsic tooth discoloration.

Back to the Dental Materials: IV - Clinical Trials Program
Back to the IADR/AADR/CADR 82nd General Session (March 10-13, 2004)

Top Level Search