2. Materials and Methods
pain
The current study was a three-arm, single-blind, randomized clinical trial executed at the College of Dental Science and Hospital, India and was approved by the institutional ethics committee (CDSH/IEC/05/2022; Approval date: 1 April 2022) and registered with the Clinical Trials Registry of India (CTRI/2022/04/041905) registered prospectively (19 April 2022). Comprehensive information regarding the required therapy was provided to the participant’s parents, and both verbal and written consents were acquired. A pilot study with 15 participants in each group was carried out as no previous research had been done implementing three groups to evaluate the post-operative pain. The findings of the pilot study Odd’s ratio of 6.5 between XP endo and Hand file and to achieve a power of 0.80 at a 0.05 level of significance and a minimum of 24 had to be evaluated but we rounded it off to 25. The G*Power (Version 3.1.9.3; Heinrich Heine University, Düsseldorf, Germany) was used to estimate the sample size. Hence, the sample size for the main investigation was 25 individuals in each group. The post-operative pain score was considered for sample size estimation as we have also recorded the pain score as ordinal data.