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Because "negative" samples cannot be used to determine a decontaminating effect, the sample size was compensated for these potential unusable samples (24%), yielding a sample size of 56 implants (42.5/0.76).
For this pilot study, we based our sample size on the number of participating centres and the minimum weekly recruitment per centre that we would tolerate if the true incidence rate was 20% (yielding a sample size of 1250 for a 25% relative risk reduction, 5% type I error rate, and 90% power).
Given CTN site norms (i.e., outpatient setting, patients whose conditions are chronic rather than acute, and significant use of structured worksheets for source data collection), we assumed a rate of 50 errors per 10,000 fields, and wished to obtain a 20 error per 10,000 field CI, yielding a sample size of 3400 fields per site.
Of the remaining 2,935 children, 76.0% were enrolled in the study, yielding a sample size of 2,230.
The first consecutive 522 male and 522 female participants were included in the study, yielding a sample size of 1044 patients.
The sample was chosen by means of accidental (non-probability) sampling, yielding a sample size of n = 259 with an α risk = 0.05 for a precision of 5%.
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Cases were included in the sample when two sites had the same type of dentin reaction detected by SM, while showing different types of dentin reactions when detected using MR. Thus, up to 6 histological sites were selected per sample, yielding a total sample size of 168 sites.
Our target sample size of 273 enrolled and 20% attrition at 12-month follow-up (yielding a final sample size of 218), assuming ICC=.1, will result in 84% power for detecting an effect size of.5, which Cohen [ 63] refers to as a "moderate" effect size.
Assuming no effect in the untreated group, the associated effect size f = .4, yielding a minimal sample size of 21 per group.
This resulted in a difference between SST and SST-PTI of 0.60 SD of the mean VABS outcome, with associated effect size f = .3, yielding a minimal sample size of 36 per group.
Sample sizes for the four sections were 42, 39, 36, and 42, yielding a combined sample size of 159.
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