Computational protocol: Randomized controlled clinical trial on bleaching sensitivity and whitening efficacy of hydrogen peroxide versus combinations of hydrogen peroxide and ozone

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Protocol publication

[…] Sensitivity of teeth (24 h after beaching) was defined as the primary endpoint of the current study. Using the pooled variance based on our previous study, we computed an effect size of 0.544 (G*Power: Statistical Power Analyses, version; Heinrich-Heine University) for an a-priori power analysis. A sample size of 12 per group was calculated as a function of the required power level (1 – β; 0.8), the pre-specified significance level α (0.05), and the population effect size to be detected with probability 1 − β. In total, 15 participants were finally selected for each group to compensate for any unexpected (but sometimes inevitable) dropouts. The humane endpoint was defined as the point at which pain induced by the bleaching procedure was not bearable anymore; in these cases, terminating the possibly painful procedure was scheduled. [...] Assigning patients to interventions and tooth bleaching was accomplished by one investigator (M.K.A.-O.), while all shade measurements and tooth sensitivity assessments were carried out by another investigator (A.A.A.N.), who was blinded to the respective bleaching technique. Intra-examiner reliability was evaluated by recording 18 duplicate shade measurements by the same investigator and Kappa was considered adequate (κ = 0.91; almost perfect conformity), thus proving high intra-examiner agreement of the standardized assessment methods.The SPSS computer software (Statistical Package for the Social Sciences, v19.0; IBM, Armonk, NY, USA) was utilized to carry out data analysis for the current study. Paired samples t-test was executed to compare shade values before and after bleaching within each group. Analysis of variance (ANOVA) was performed to compare shade values between groups. Post-hoc test was carried out for additional comparisons of shade values between groups at baseline and after bleaching. Statistically significant levels were set at p < 0.05, with a 95% confidence interval. A post-hoc power calculation analysis based on the sensitivity means and standard deviations was conducted to compute the actual power level (G*Power, version; Heinrich-Heine University, Düsseldorf, Germany). […]

Pipeline specifications

Software tools G*Power, SPSS
Application Miscellaneous
Organisms Homo sapiens
Chemicals Hydrogen Peroxide, Ozone