Sample size
trismus, pain
SECONDARY, TRISMUS
The sample size was calculated in the OpenEpi 3.01 program through the mean differences of the outcome variable “swelling” between the study groups in a pilot study (mean difference set as 2.61, with standard deviation of 2.57 and 2.31 for groups primary and secondary closure, respectively), establishing a 95% confidence interval and 80% power, with type I error of 0.05. On the basis of these values, a minimum sample size of 28 patients was calculated to be necessary, with this number being greater than the sample sizes calculated for the other variables (pain and trismus).