Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate vs Resin-Based Sealers

A Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate Versus Resin-based Sealers in Cases With Symptomatic Irreversible Pulpitis

This is a randomized controlled trial comparing the mean and standard deviation of postobturation pain using two different sealers: a tricalcium silicate-based sealer (CeraSeal) and a resin-based sealer (Endoplus) in patients with symptomatic irreversible pulpitis undergoing root canal treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: Tricalcium silicate sealar; Drug: Resin based sealer

Detailed Description

• The study will be conducted after approval from the Institutional Ethics Review Committee of the Armed Forces Institute of Dentistry. Informed written consent will be obtained from all patients, and demographic details (name, age, gender, and contact information) will be collected. This is a randomized clinical trial, and the sample size will be divided into two groups using computer-generated randomization. Group 1 will receive Endoplus (resin-based sealer), and Group 2 will receive CeraSeal (bioceramic sealer).

All root canal procedures will be performed by the principal investigator. At the first visit, local anesthesia (2% lignocaine with 1:100,000 epinephrine) and rubber dam isolation will be used. Working length will be determined using an apex locator and confirmed with a periapical radiograph. Chemo-mechanical preparation will be performed using 2.5% sodium hypochlorite (NaOCl) and 17% ethylenediaminetetraacetic acid (EDTA). Cleaning and shaping will be done up to F2 ProTaper using hand files and nickel-titanium (NiTi) rotary files, with recapitulation between each file to maintain canal patency. Non-setting calcium hydroxide will be placed as an intracanal medicament, followed by a temporary restoration with Cavit. Patients will be recalled after one week for obturation and will proceed only if asymptomatic.

At the second visit, obturation will be carried out according to group allocation. Group 1 will receive Endoplus resin-based sealer using a single-cone gutta-percha technique with a heated plugger (System B). Group 2 will receive CeraSeal bioceramic sealer with matched bioceramic cones using the same System B technique. Accessory cones will be used for wide or irregular canals. A permanent composite restoration (Coltene) will be placed, and occlusion will be adjusted.

Postoperative pain will be recorded using a Visual Analogue Scale (VAS) at 24 hours, 72 hours, and 7 days. Ibuprofen will be prescribed only if the pain becomes unbearable, and patients will document the dose and frequency taken. Two independent blinded endodontists will evaluate radiographs for technical errors or sealer extrusion. The primary measure of success will be the level of postoperative pain at follow-up, comparing outcomes between Endoplus resin-based sealer and CeraSeal bioceramic sealer.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pooja Kumari; Phone Number: 03133422793; Email: dhomejapooja@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 46000
      • Armed Force Institute of Dentistry
      • Contact: Pooja Kumari; Phone Number: 03133422793; Email: dhomejapooja@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Patients of age group 18 to 60 years

  • Healthy patients with ASA class 1 and 2
  • Patients of both genders
  • Teeth diagnosed as symptomatic irreversible pulpitis
  • Single as well as multirooted teeth

Exclusion Criteria:

• Teeth with calcified or previously treated canals
• Immunocompromised or mentally handicapped patients
• Pregnant or lactating mothers
• Teeth with periodontal probing depths of 5 mm or more
• Cracked or un restorable teeth
• Teeth where root canal instrumentation could not reach within 2 mm of the radiographic apex

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tricalcium silicate based sealer (Bio ceramic); CeraSeal bioceramic sealer will be used for obturation with matched bioceramic cones and a heated plugger (System B).	Drug: Tricalcium silicate sealar; Ceraseal (bioceramic sealer) - assigned to Group 2; Other Names: CeraSeal sealer, bioceramic sealer, calcium silicate sealer
Experimental: Resin based sealer; Endoplus resin-based sealer will be used for obturation with single-cone gutta-percha and a heated plugger (System B)	Drug: Resin based sealer; Endoplus (resin-based sealer) - assigned to Group 1; Other Names: Endoplus sealer, resin sealer, gutta-percha sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain after root canal treatment assessed using a Visual Analogue Scale (VAS)	Postoperative pain will be recorded using a 10-centimeter Visual Analogue Scale (VAS). On this scale, 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores correspond to greater pain intensity, meaning more pain. Patients will self-report their pain level at each time point (24 hours, 72 hours, and 7 days). This measure will be used to compare postoperative pain between patients treated with Endoplus resin-based sealer and CeraSeal bioceramic sealer.	24 hours, 72 hours and 7 days

Collaborators and Investigators

• Sponsor: Armed Forces Institute of Dentistry, Pakistan

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: bioceramic sealer; root canal sealar; postobturation pain; resin based sealar
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; epoxy resin-based root canal sealer
• Other Study ID Numbers: Protocol-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data (IPD) will not be shared with other researchers because this trial involves a small patient sample, and the data contains identifiable clinical information that cannot be fully anonymized without compromising patient confidentiality. The dataset is intended solely for analysis within the approved research protocol, as permitted by the Institutional Ethics Review Committee. Therefore, IPD sharing is not planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes