Assessment of clinical and radiographic efficiency of manual and pediatric rotary file systems in primary root canal preparation: a randomized controlled clinical trial

Abstract

IntroductionThe success of primary teeth pulpectomy is strongly reliant on instrumentation techniques and their impact on obturation quality & postoperative pain. Recently, pediatric rotary file systems have been implemented.Aimto compare two pediatric rotary file systems (Kedo-S-Square & Fanta AF™ Baby) with manual K-files concerning obturation quality, instrumentation time, and postoperative pain in root canal preparation of primary molars using cone beam computed tomography (CBCT).MethodsA randomized clinical trial was conducted with the trial registration number (TRN: NCT05619796 and date of registration: (17/11/2022) on sixty primary lower 2nd molars in healthy children aged 4–7 years. Molars were assigned randomly to three groups (n = 20). Group-I and -II were prepared with Kedo-S-Square & Fanta AF™Baby rotary systems respectively while group-III was prepared with a manual K-file. Instrumentation time was recorded using a stopwatch. CBCT was used to assess obturation quality immediately & recorded as optimal, underfilled, or overfilled. Postoperative pain was evaluated at 6, 12, 24, 48 h-time intervals using a four-point pain intensity scale. Statistical analysis was performed for the collected data.ResultsAmong the three groups, group-I revealed a greater number of optimally filled teeth (85%) & less instrumentation time (74.75 s) followed by group-II & manual-K file group (p < 0.05). The hand K-file group had significantly more postoperative pain than the two rotary groups (p < 0.05).Conclusionthe tested rotary file systems resulted in better obturation quality, less instrumentation time, and less postoperative pain compared to manual-K files during primary teeth pulpectomy.