Clinical and radiological outcomes of Thermafil Plus used with bioceramic versus epoxy-resin sealer: results from a 12-month randomized clinical trial

This randomized clinical trial compared the clinical and radiographic outcomes and post-operative pain of a bioceramic-containing sealer (AH Plus Bioceramic) versus an epoxy resin-based sealer (AH Plus) in primary and secondary root canal treatments over 12-month follow-up. A total of 99 permanent teeth from ASA I or II patients were enrolled and randomly allocated to two groups: group A (AH Plus Bioceramic) and group B (AH Plus). Six patients (8 teeth) were excluded from the analysis due to missed follow-up appointments, leaving 91 teeth (group A: n = 47; group B: n = 44) for evaluation. Standardized endodontic procedures and disinfection protocols were followed. All root canals were obturated using Thermafil Plus in combination with the assigned sealer. Radiographic evaluations were performed at baseline, 1-, 3-, 6- and 12-month follow-ups and periapical index was recorded. The presence or resorption of apical sealer extrusions was also recorded. Postoperative pain was evaluated using the Visual Analog Scale before treatment, at 24 h, 48 h, 72 h, one week and one month. At the 12-month follow-up, both sealers demonstrated a high success rate. In group A 87.2% of teeth were healed. In group B 90.9% of teeth were healed and one tooth (2.3%) was extracted and was considered as treatment failure. No significant differences were found between groups in terms of radiographic healing (p > 0.05). Sealer extrusion was observed in both groups (group A = 53%; group B = 66%). Radiographic resorption of extruded sealer was observed only in group A, whereas partial morphological modification was uncommon and occurred in both groups. No significant between-group differences were observed in periapical healing or postoperative pain. AH Plus Bioceramic and AH Plus sealers, when used with Thermafil Plus, showed similar 12-month clinical and radiographic outcomes. ClinicalTrials.gov: NCT06252337.