1- Based on study procedures (allocation on two lines of NiTi) and the used references, it is a randomized trial not observational study.
2- Despite the applicant emphasize on sample size calculation based on reference, she does not mention the number determined.
3- This study needs to modify the age of participants to 21
4- This study needs Informed consent form
I do not Know, if the applicant needs to add control group or it is already present