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Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers

Sponsor: European University of Lefke • ClinicalTrials.gov ID: NCT07608939

Registry updated: 2026-09-11

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Description

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.

Interventions

AH Plus Root Canal Sealer (Device)
AH Plus is an epoxy resin-based root canal sealer used during obturation with a modified single-cone technique. The material is characterized by high dimensional stability, good sealing ability, low solubility, and adhesion to dentin and gutta-percha. Root canal treatment procedures, instrumentation protocol, irrigation regimen, and obturation technique will be standardized for all participants.
ProRoot Bio Sealer (Device)
ProRoot Bio Sealer is a calcium silicate-based bioceramic root canal sealer used during obturation with a modified single-cone technique. The material contains bioactive cement components designed to promote hydroxyapatite formation and maintain an alkaline environment. The study will use standardized instrumentation, irrigation, and obturation protocols identical to the other intervention groups.
BC Sealer ion+ Sealer (Device)
BC Sealer ion+ is an Akermanite-based premixed bioceramic root canal sealer used during obturation with a modified single-cone technique. The material releases calcium and magnesium ions and is designed to enhance bioactivity and tissue healing potential. All other clinical procedures, including instrumentation, irrigation, and restoration protocols, will remain standardized across study groups.

Eligibility criteria

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 * Asymptomatic teeth showing delayed positive responses to thermal testing (EndoIce; Coltene/Whaledent Inc.) and electric pulp testing (Parkell) * Teeth with extensive pulp exposure during caries excavation * Inflamed pulp tissue in which bleeding cannot be controlled within 5 minutes * Periodontally healthy, mature mandibular first or second molars Exclusion Criteria Patients presenting with the following conditions will be excluded from the study: * Diabetes mellitus, immunocompromised conditions, or pregnancy * Use of antibiotics within the last month or requirement for antibiotic prophylaxis * Use of analgesics within 7 days prior to treatment * Allergy to any material used during root canal treatment * Teeth suitable for vital pulp therapy in which bleeding can be controlled within 5 minutes * Non-vital or symptomatic teeth * Presence of radiographically detectable periapical lesions * Teeth requiring post-core restorations or prosthetic support * Calcified root canals, root resorption, or immature teeth

Conditions

Irriversible Pulpitis

Locations

European University of Lefke — Lefka, Cyprus

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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