Statistical analysis
pain
ADVERSE EVENTS
Sample size calculation was performed as follows: VAS was used as an evaluation item in this clinical trial, whereas the NRS was used in the exploratory clinical trial. We therefore converted the NRS value to the VAS value (NRS value 10 → VAS value 100). The improvement rate of PJD treatment was estimated as 71.3 ± 28.2 [The improvement rate of air pain was calculated as follows:Assuming the average improvement of air pain of the PJD group as µH0: µH1: µNon-inferiority was verified by unpaired t-test.For scratch pain, non-inferiority was verified by unpaired t-test using a temporary structure similar to the primary endpoint.For adverse events determined to be related to the PJD-UNIT, the incidence rate was calculated for each treatment. The incidence rate for PJD and TMD treatments were statistically compared using Fisher’s exact test.