Randomized Trial of Bioceramic Apical Barrier Methods in Necrotic Immature Incisors: Effects on Pain, Extrusion, and Procedure Duration

<b>Objective</b>: This randomized controlled trial evaluated postoperative pain (PP), bioceramic extrusion, and procedure duration in necrotic immature incisors treated with three apical barrier methods (ABMs): Bioceramic Putty Apical Plug (BPAP), Single Cone with Bioceramic Sealer (SBS), and Bioceramic Putty-Sealer Mixture (BPSM). Case-related factors influencing these outcomes were also examined. <b>Methods</b>: Ninety-nine children (8-11 years) with necrotic maxillary incisors and moderate periapical lesions were randomly assigned (1:1:1) to BPAP, SBS, or BPSM groups. Standardized protocols included calcium hydroxide dressing and XP-Endo Finisher irrigation. Pain (VAS) was recorded at 1-, 3-, 7-, and 14-day post-treatment. Extrusion (yes/no) and procedure duration were documented. Regression analyses identified predictors of outcomes. <b>Results</b>: At day 1, pain was highest in the BPAP group (mean 3.5) and lowest in the SBS group (mean 1.05; <i>p</i> < 0.001). Pain decreased substantially by day 3 and resolved in all groups by day 14. Extrusion was most frequent in SBS (60.6%) and least frequent in BPAP (21.2%; <i>p</i> = 0.002). Treatment duration was longest in BPAP (25.8 min) and shortest in SBS (12.6 min; <i>p</i> < 0.001). Regression showed that preoperative pain and pulpal diagnosis were the strongest predictors of postoperative pain. Apical size and ABM predicted extrusion, while apical size and child behavior significantly influenced duration. <b>Conclusions</b>: The apical barrier method had a significant impact on short-term outcomes. SBS offered reduced pain and shorter chair time but carried a higher risk of extrusion, while BPAP minimized extrusion but caused more pain and required more extended visits. Clinical selection should balance patient comfort, apical anatomy, behavior, and operator expertise. Longer-term outcomes on periapical healing remain to be evaluated.