💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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