Bioceramic Versus Epoxy Resin-Based Root Canal Sealer and Postoperative Pain After Warm Vertical Compaction

Background: Postoperative pain is a common complication of root canal treatment, and the chemical composition of the root canal sealer has been proposed as one of the factors influencing its incidence and intensity. Epoxy resin-based AH Plus is widely regarded as the reference sealer, whereas calcium silicate-based bioceramic sealers have gained popularity because of their biocompatibility, alkaline pH and hydraulic setting properties. Clinical evidence comparing these sealers in terms of postoperative pain remains inconsistent, and data obtained with warm vertical compaction are limited.

Design: This is a prospective, randomized, active-controlled, parallel-group, single-center clinical trial conducted at the Department of Endodontics, Faculty of Dentistry, Ataturk University (Erzurum, Turkey). Asymptomatic single-rooted maxillary anterior teeth with a diagnosis of pulp necrosis and normal apical tissues (periapical index score ≤2) will be included. A total of 70 participants (35 per group) will be allocated to one of two groups: Group 1, TotalFill BC Sealer HiFlow (FKG Dentaire SA, Switzerland); Group 2, AH Plus (Dentsply Sirona). Allocation will be performed using a computer-generated randomization sequence (www.randomizer.org). Participants will be blinded to group allocation; because pain will be self-reported by the participants, outcome assessment will also be blinded. Due to the different handling properties of the sealers, the operator cannot be blinded.

Treatment protocol: All treatments will be performed by a single operator following a standardized protocol. After local anesthesia and rubber dam isolation, the access cavity will be prepared and the working length determined with an electronic apex locator. Root canals will be shaped with a rotary instrumentation system and irrigated with 2.5% sodium hypochlorite, followed by a final rinse with distilled water. After drying, the assigned sealer will be applied and the canal obturated with the warm vertical compaction technique in both groups. Preoperative clinical and radiographic findings, including the periapical index (PAI) score, will be recorded on a standardized form.

Outcome assessment: Participants will rate their pain on a 100-mm Visual Analogue Scale (VAS) at 6, 12 and 24 hours and on days 3, 5 and 7 after treatment. Paracetamol 500 mg will be recommended as rescue medication, and analgesic intake (yes/no, day and time) will be recorded. Participants will be clinically re-examined one week after treatment for percussion and palpation sensitivity, swelling and sinus tract.

Statistical analysis: Normality will be tested with the Shapiro-Wilk test. Between-group comparisons will be performed with the independent-samples t-test or Mann-Whitney U test, and categorical variables with the chi-square or Fisher's exact test. Changes in pain over time will be analyzed with repeated-measures ANOVA or the Friedman test, as appropriate. The level of significance will be set at p<0.05.