Placebo-controlled clinical trial evaluating a 10% hydrogen peroxide whitening strip.

OBJECTIVE: A placebo-controlled clinical trial was conducted to evaluate the effectiveness and safety of a 10% hydrogen peroxide strip-based whitening system in subjects with tooth discoloration and no previous history of tooth whitening. METHODOLOGY: Informed consent was obtained, and 39 healthy adults were randomly assigned to either 10% hydrogen peroxide whitening strips (Crest Whitestrips Premium) or placebo strips with no peroxide. Strips were used unsupervised twice daily for 30 minutes over a seven-day period. At day four and day eight, tooth color (L*a*b*) was measured on the maxillary anterior teeth from standard digital images, and safety was assessed from examinations and subject reports. RESULTS: After three treatment days, the 10% hydrogen peroxide strip group had significant (p < 0.0001) color improvement from baseline, with means (SD) for deltab* and deltaL* of -1.57 (0.472) and 1.72 (0.619), respectively. Continued strip use from day four to day eight resulted in significant (p < 0.002) incremental improvement in both yellowness and lightness. By the end of treatment (day eight), the adjusted mean (SE) color change between groups was -2.20 (0.275) for deltab* and 2.24 (0.254) for deltaL*, a highly significant (p < 0.0001) color improvement for the 10% hydrogen peroxide group relative to placebo, of similar absolute magnitude for deltab* and deltaL*. Treatment with the 10% hydrogen peroxide strips was well-tolerated, with tooth sensitivity and oral irritation representing the most common findings. CONCLUSION: In this double-blind, placebo-controlled clinical trial, statistically significant tooth whitening was evident after three days' treatment with 10% hydrogen peroxide whitening strips, and color improved with continued usage over seven days.

Placebo-controlled clinical trial of a 19% sodium percarbonate whitening film: initial and sustained whitening.

PURPOSE: To evaluate in a randomized, double-blind, placebo-controlled clinical trial the initial, cumulative and sustained whitening with a brush-applied, peroxide-based, overnight tooth whitener. METHODS: 50 adults were randomized to Crest Night Effects, a 19% sodium percarbonate gel that dries to form an adherent film, or a placebo gel without any peroxide source. The treatments were brush-applied at night, and removed the next morning with normal toothbrushing. Subjects were evaluated biweekly during the 6-week treatment period to evaluate initial and cumulative color change, and again, 4 weeks after completion of treatment to evaluate color relapse. Efficacy was determined by evaluating reduction in tooth yellowness (delta b*), increase in tooth brightness (delta L*) and overall change relative to white (delta W*) from standardized digital images. Tolerability was assessed by examination and interview conducted at treatment and post-treatment visits. RESULTS: Relative to baseline, the 19% sodium percarbonate film group had significantly (P < or = 0.013) whiter teeth after 2 weeks overnight use. For maxillary teeth, delta b* and delta L* means (SD) were: -1.35 (0.858) and 1.06 (0.886), respectively. For mandibular teeth, delta b* and delta L* means (SD) were: -1.27 (0.903) and 0.56 (0.790), respectively. Relative to placebo, the 19% sodium percarbonate group was significantly (P < 0.005) better than placebo for delta b*, delta L*, and delta W*. There was a cumulative benefit with additional treatment, as evidenced by significant (P < 0.0001) improvement in mean delta b* after the initial 2 weeks of treatment. Approximately 90% of the 6-week cumulative color improvement was still evident after 4 weeks post-treatment. Tooth sensitivity (20% of the peroxide group) represented the only adverse event with increased occurrence over placebo, and these events were mild and fully resolved during/after treatment.

Vital bleaching with two at-home professional systems.

PURPOSE: To compare the whitening effectiveness of two professional vital bleaching systems in a randomized clinical trial. MATERIALS AND METHODS: Balancing for baseline color, 6 9 adult volunteers were randomized to either a whitening strip containing 6.5% hydrogen peroxide (Professional Crest Whitestrips) or a custom tray-based system using both hydrogen and carbamide peroxide (Nite White Excel2). Total contact time was 21 hours for the strip system and 28 hours for the 10% carbamide peroxide equivalent tray system. Whitening response was measured objectively as L*a*b* from digital images of the maxillary anterior teeth. RESULTS: Both treatments resulted in significant (P < 0.01) improvements in yellowness (deltab*), brightness (deltaL*) and overall color (deltaE*). For between group comparisons, strip subjects had a statistically significant or directionally favorable whitening response relative to the tray system at intermediary time points, while at the end-of-treatment, the strip group had highly statistically significant (P < or = 0.005), superior whitening response for all color parameters measured in the study. Both treatments were generally well tolerated, with 35-40% of the subjects in each group reporting minor tooth sensitivity or gingival irritation.