Post-Operative Pain Following Treatment Using the Gentlewave System: A Randomized Controlled Trial

University of Minnesota M.S. thesis. August 2019. Major: Dentistry. Advisors: Ronald Ordinola-Zapata, Scott McClanahan. 1 computer file (PDF); vii, 40 pages.INTRODUCTION: Cleaning and shaping are necessary to allow for the delivery of irrigants and medicaments to the apical third of the canal. Standard treatment irrigation generally uses a conventional needle and some frequency of sonic activation. The GentleWave® system (GWS) (Sonendo, Inc, Laguna Hills, CA) combines irrigant delivery with Multisonic activation. The aim of this randomized clinical trial was to determine if the GWS significantly decreases the incidence and intensity of post-operative pain. METHODS: Patients used a numerical rating scale (NRS) to record their pain level at the six-hour timepoint before treatment. All participants were randomly divided into two groups and were blind to the treatment they received. The standard (control) group received endodontic treatment with conventional side-vented needle irrigation and ultrasonic activation. The 2nd group received treatment with the GWS. Following treatment, patients used an NRS to record their pain level at six, 24, 72, and 168 hours RESULTS: 72.2% of standard treatment patients and 83.3% of GWS patients experienced at least one occurrence of post-operative pain. The highest pain intensity level for both treatments occurred at the six-hour post-treatment timepoint. The mean pain intensity for standard treatment was 23.22 (+/- 25.38) and for GWS treatment intensity = 11.56 (+/- 9.94) (p = 0.0826). All pain decreased with time after the six-hour post-treatment time point (p < 0.0000001237). CONCLUSION: There was no significant difference in the incidence or intensity of post-operative pain following either treatment group. However, both groups reported a statistically significant decrease in pain with time