Effectiveness of a New Bleaching Agent After Single Use Treatment

Objectives: This in-vivo study was aimed to examine whitening effects for frontal teeth of the upper and lower jaw using an OTC non-hydrogen peroxide bleaching agent (BA) in comparison to a placebo (P) after single-use.
Methods: Forty subjects (25♀;15♂) participated in this double-blind randomized controlled trial. The subjects were randomly allocated into two groups (n=20). Group (BA) received the OTC product iWhite Instant with Pthalimido-Peroxy-Capronacid and group (P) the placebo with identical application and composition except for the active agents. Before initiation of the study the kappa-coefficient-value for intra-examiner-reliability was determined (0.83).
Each subject was treated with a pre-filled application tray containing iWhite Instant or the placebo. The tooth shade of the teeth 13-23 and 33-43 was assessed before treatment (E0), immediately after (E1) and 24h after (E2) treatment. The tooth shades were recorded with a value-oriented shade guide (Vita classical) using a light (1) to dark (16) scale. Statistical testing was accomplished using Mann-Whitney-U-Test (p<0.001).
Results: The dropout rate was 0%. There were no significant differences at the baseline measurements (E0) between P and BA regarding the assessed tooth color. Differences in tooth color changes immediately after single use (ΔE0_E1) and 24h after (ΔE0_E2) the treatment were calculated for both groups. The means (standard deviations) of tooth color changes (overall color changes) regarding ΔE0_E1 were 2.26 (0.92) for BA and 0.01 (0.21) for P. Overall color changes for ΔE0_E2 showed means (standard deviations) of 2.15 (1.10) for BA and 0.07 (0.35) for P. For ΔE0_E1 and ΔE0_E2 significant differences were found between the use of iWhite Instant and the placebo.
Conclusions: Within the limitations of this study, the results showed that a non-hydrogen peroxide bleaching agent has whitening effects immediately and 24h after single-use treatment.