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

Objective: 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. Methods: 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. Results: At day 1, pain was highest in the BPAP group (mean 3.5) and lowest in the SBS group (mean 1.05; p < 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%; p = 0.002). Treatment duration was longest in BPAP (25.8 min) and shortest in SBS (12.6 min; p < 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. Conclusions: 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.