The effect of Low Intensity Pulsed Ultrasound Therapy on post-operative pain in endodontically treated tooth - A Randomized Clinical Trial

This study is a randomized clinical trial comparing the postoperative pain in endodontically treated tooth with and without the use of low intensity pulsed ultrasound therapy that will be conducted in India. The primary outcome is to evaluate the effect of low intensity pulsed ultrasound therapy on postoperative pain in endodontically treated tooth using visual analogue scale at 6 hour, 24 hour, 48 hour, 72  hour and  5th day, to evaluate the postoperative pain in endodontically treated tooth without ultrasound therapy using visual analogue scale at 6 hour, 24 hour, 48 hour, 72  hour and  5th day, to compare the effect the postoperative pain in endodontically treated tooth with and without the use of low intensity pulsed ultrasound therapy using visual analogue scale at 6 hour, 24 hour, 48 hour, 72 hour and 5th day. Participants will be randomly allocated to each group; GROUP 1-With low intensity pulsed ultrasound  therapy (n=30) and GROUP 2–Without  low intensity pulsed ultrasound  therapy. Access opening will be done using Endo access bur and Endo Z bur according to traditional endodontic access cavity preparation. The contents of the canal will be debrided with sterile 15 k file using push pull motion. Working length will be determined 1mm short of the apex using electronic apex locator and will be confirmed by radiograph. Cleaning and shaping will be done by appropriate technique depending on the configuration of the canal. Canals will be irrigated with 2ml of 17% EDTA and final rinse with sterile saline will be done  as per the standard protocol. The teeth will be given calcium hydroxide intracanal dressing and cavit placement will be done. Low intensity ultrasound therapy will be given intraorally for 10-15 mins of time duration as per the group. In group 2, blinding will be done  by giving the placebo effect (keeping the device ON with 0 intensity). Every patient will be given a VAS scale chart to keep track of their pain at the following intervals-6 hour, 24 hours, 48 hours, 72 hours and 5th day. Obturation will be done as per the standard protocol using gutta percha and sealer on third day and second session of Low intensity ultrasound therapy will be given again for 10-15 mins of time duration. The final restoration with the composite resin will be done as a post endodontic restoration on fifth day and third session of Low intensity ultrasound therapy will be given for 10-15 mins of time duration.