Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers
NCT: NCT07608939 · NOT_YET_RECRUITING
Brief Summary
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.
Frequently Asked Questions
What is Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers?
Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers is a clinical trial registered under NCT07608939. Current status: NOT_YET_RECRUITING.
What is the status of NCT07608939?
The current status of NCT07608939 (Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers) is: NOT_YET_RECRUITING.
When did Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers start?
Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers started on 2026-05-16.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.