PURPOSE: To compare the efficacy and safety outcomes of two tooth-whitening systems. METHODS:44 subjects, 12-17 years of age, participated in the study and were divided into two balanced groups. 15 subjects received 6.5% hydrogen peroxide professional whitening strip treatment and 29 subjects received 9.5% hydrogen peroxide high-adhesion whitening strips to wear for 30 minutes twice a day. Teeth were bleached for 20 days with the 9.5% hydrogen peroxide strips and 21 days with the 6.5% hydrogen peroxide strips. Digital image analysis measured color in b*, L*, and a* color spaces, where b* indicated yellowness, L* indicated lightness, and a* indicated redness at days 8, 11 and 22 for both the maxillary and mandibular arches. Oral examinations and interviews were used to ascertain any adverse events that may have occurred during treatment. RESULTS:36 subjects completed the study. At each post-baseline visit, both of the treatment groups had statistically significant (P < 0.02) mean color improvement from baseline for b*, L* and a*. The 9.5% hydrogen peroxide strips group provided statistically greater reduction in yellowness (deltab*) relative to the 6.5% hydrogen peroxide strips group for each visit of in the maxillary arch (P < 0.02) and for Day 8 and Day 22 in the mandibular arch (P < 0.02). In addition, the 9.5% hydrogen peroxide high-adhesion strip group provided statistically greater improvement in lightness (deltaL*) relative to the 6.5% hydrogen peroxide strip group for each visit in the maxillary arch (P < or = 0.007) and for the final visit in the mandibular arch (P = 0.002). 18 subjects (62%) in the 9.5% hydrogen peroxide high-adhesion strip group reported adverse events compared to 8 subjects (53%) in the 6.5% hydrogen peroxide polyethylene strip group. Minor and transient tooth sensitivity and oral irritation were the most common adverse events.
RCT Entities:
PURPOSE: To compare the efficacy and safety outcomes of two tooth-whitening systems. METHODS: 44 subjects, 12-17 years of age, participated in the study and were divided into two balanced groups. 15 subjects received 6.5% hydrogen peroxide professional whitening strip treatment and 29 subjects received 9.5% hydrogen peroxide high-adhesion whitening strips to wear for 30 minutes twice a day. Teeth were bleached for 20 days with the 9.5% hydrogen peroxide strips and 21 days with the 6.5% hydrogen peroxide strips. Digital image analysis measured color in b*, L*, and a* color spaces, where b* indicated yellowness, L* indicated lightness, and a* indicated redness at days 8, 11 and 22 for both the maxillary and mandibular arches. Oral examinations and interviews were used to ascertain any adverse events that may have occurred during treatment. RESULTS: 36 subjects completed the study. At each post-baseline visit, both of the treatment groups had statistically significant (P < 0.02) mean color improvement from baseline for b*, L* and a*. The 9.5% hydrogen peroxide strips group provided statistically greater reduction in yellowness (deltab*) relative to the 6.5% hydrogen peroxide strips group for each visit of in the maxillary arch (P < 0.02) and for Day 8 and Day 22 in the mandibular arch (P < 0.02). In addition, the 9.5% hydrogen peroxide high-adhesion strip group provided statistically greater improvement in lightness (deltaL*) relative to the 6.5% hydrogen peroxide strip group for each visit in the maxillary arch (P < or = 0.007) and for the final visit in the mandibular arch (P = 0.002). 18 subjects (62%) in the 9.5% hydrogen peroxide high-adhesion strip group reported adverse events compared to 8 subjects (53%) in the 6.5% hydrogen peroxide polyethylene strip group. Minor and transient tooth sensitivity and oral irritation were the most common adverse events.