Comparison of Postoperative Pain Following Root Canal Treatment Using AH Plus, ProRoot Bio Sealer, and BC Sealer Ion+: A Randomized Clinical Trial
Comparison of Postoperative Pain Following Root Canal Treatment Using AH Plus, ProRoot Bio Sealer, and BC Sealer Ion+: A Randomized Clinical Trial
This prospective randomized clinical trial aims to compare the effects of three different root canal sealers-AH Plus, ProRoot Bio Sealer, and BC Sealer ion+-on postoperative pain following root canal treatment in patients diagnosed with asymptomatic irreversible pulpitis.
Postoperative pain is a common complication after endodontic treatment and may be influenced by microbial, chemical, and mechanical factors. The type and composition of root canal sealer may also affect tissue response, inflammation, and pain levels. AH Plus is an epoxy resin-based sealer known for its sealing ability and dimensional stability, whereas ProRoot Bio Sealer and BC Sealer ion+ are bioceramic sealers with enhanced bioactive properties. BC Sealer ion+ additionally releases both calcium and magnesium ions, which may improve tissue healing and biological performance.
The study will include patients aged 18-60 years presenting with asymptomatic irreversible pulpitis in mandibular first or second molars. Following ethical approval from the European University of Lefke Ethics Committee, approximately 135 patients will be enrolled and randomly assigned into three equal groups according to the root canal sealer used. Sample size calculation was performed using G*Power software with 80% statistical power and a significance level of 0.05.
All treatments will be completed in a single visit by the same experienced clinician under standardized clinical conditions. Root canal preparation will be performed using the ProTaper Universal rotary system with standardized irrigation protocols including sodium hypochlorite, EDTA, chlorhexidine, and sonic activation. Obturation will be completed using a modified single-cone technique with the assigned root canal sealer.
Patients and the outcome assessor will be blinded to group allocation. Postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 6, 12, 24, 48, and 72 hours, as well as on day 7 after treatment. Secondary outcomes will include analgesic consumption and flare-up incidence. All patients will be prescribed ibuprofen to use only if necessary, and analgesic intake will be recorded.
The primary objective of this study is to determine whether different root canal sealers significantly influence postoperative pain levels after root canal treatment. The null hypothesis states that there will be no statistically significant difference among AH Plus, ProRoot Bio Sealer, and BC Sealer ion+ regarding postoperative pain outcomes. Data will be analyzed using appropriate statistical methods, with a significance level set at P < 0.05.
Postoperative pain following root canal treatment remains one of the most important factors affecting patient comfort and perceived treatment success in endodontics. The occurrence and intensity of postoperative pain may be influenced by several factors, including instrumentation techniques, irrigation protocols, extrusion of debris or filling materials into periapical tissues, and the physicochemical properties of root canal sealers. Bioceramic sealers have gained increasing popularity because of their bioactivity, biocompatibility, antibacterial properties, and potential to enhance periapical healing. However, limited clinical evidence is available regarding their influence on postoperative pain when compared with conventional epoxy resin-based sealers.
This prospective randomized clinical trial is designed to evaluate and compare postoperative pain levels after root canal treatment performed using three different root canal sealers: AH Plus, ProRoot Bio Sealer, and BC Sealer ion+. The study will include adult patients diagnosed with asymptomatic irreversible pulpitis in mandibular first or second molars requiring primary root canal treatment. All clinical procedures will be performed in a standardized manner by a single experienced clinician to minimize operator-related variability.
Root canal preparation will be completed using the ProTaper Universal rotary instrumentation system under standardized irrigation and disinfection protocols. Canal irrigation will include sodium hypochlorite, EDTA, chlorhexidine, and sonic activation procedures. Obturation will be carried out using a modified single-cone technique with gutta-percha cones corresponding to the final preparation size and the allocated root canal sealer. Randomization will be performed using computer-generated allocation, and allocation concealment will be ensured with sealed opaque envelopes. The study will follow a single-blind design in which participants and outcome assessors remain unaware of group assignment.
AH Plus is an epoxy resin-based sealer widely used because of its dimensional stability, sealing ability, and long-term clinical performance. ProRoot Bio Sealer is a calcium silicate-based bioceramic sealer with enhanced bioactive cement content and a flexible delivery system designed to improve handling and material placement. BC Sealer ion+ is an Akermanite-based premixed bioceramic sealer capable of releasing both calcium and magnesium ions, which may contribute to improved tissue healing, stem cell differentiation, and prolonged bioactivity. Structural differences between conventional calcium silicate materials and Akermanite-based formulations may influence ion release kinetics and tissue responses, potentially affecting postoperative symptoms.
Postoperative pain intensity will be recorded using the Numeric Rating Scale (NRS) at predetermined postoperative intervals. Analgesic intake and flare-up incidence will also be monitored throughout the follow-up period. Statistical analysis will be performed using appropriate parametric or non-parametric tests according to data distribution, with statistical significance established at P < 0.05. The findings of this study may contribute to a better understanding of the clinical performance of contemporary bioceramic sealers and their potential influence on postoperative pain management in endodontic treatment.
Patient Selection Patients will be selected from individuals referred to the Dental Clinic for root canal treatment. Only mandibular first or second molars diagnosed with asymptomatic irreversible pulpitis will be included in the study. Asymptomatic irreversible pulpitis is defined as inflamed vital pulp tissue without clinical symptoms, usually caused by caries, caries excavation, or trauma.
Before treatment, written and verbal informed consent will be obtained from all participants. An online questionnaire including the Numeric Rating Scale (NRS) and the number of analgesics taken will be electronically sent to the participants. Patients will subsequently be contacted by telephone and asked to complete the questionnaire online. Submitted responses will not be modifiable after completion. The primary outcome will be postoperative pain, while secondary outcomes will include analgesic consumption and flare-up incidence.
Inclusion Criteria
Patients presenting with the following conditions will be excluded from the study: