Methodology
The sample size was estimated using the G*Power 3.0.10 software, setting the alpha level at 0.05 and power at 80%. The effective sample size was calculated as 0.20. Based on these criteria, the ideal number of participants in each group was calculated to be 16, which generated a total sample size of 64.Following clearance from the Institutional Ethics Committee (Certificate No: KIDS/IEC/NOV-2019/36), 16 volunteering subjects who met the inclusion and exclusion criteria were recruited for this prospective double-blind, split-mouth, randomized placebo controlled trial after signing an informed consent document, in accordance with the Declaration of Helsinki (2013) (
