Sample calculation and randomization
The sample size was calculated given an effect size of 0.5. With a power of 85% and a type I error of 0.05, 29 patients would have been needed. The randomization was processed using a computer-generated random shortlist. Each treatment (test and control) was assigned to the specific site (left or right M3M) by choosing between identical, opaque envelopes containing different possible combinations. One operator, not involved in surgeries, knew the assignments and administered drugs to the patients accordingly.