Postoperative Pain After Root Canal Obturation Using Bioceramic and Calcium Hydroxide Sealers (BCvsCaOH)

February 13, 2026 updated by: monal fatima, HITEC-Institute of Medical Sciences

Assessment of Postoperative Pain in Patients Obturated With Bioceramic and Calcium Hydroxide Sealers: A Randomized Clinical Trial

This study is designed to find out how different root canal sealers affect pain after root canal treatment. We are comparing two types of dental sealers: bioceramic sealer and calcium hydroxide sealer.

Participants who need root canal treatment will receive one of these sealers as part of their standard dental care. After the procedure, they will be asked to report any pain they experience for a few days.

The information from this study will help dentists choose sealers that may reduce post-treatment pain and improve patient comfort after root canal therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled clinical trial is designed to evaluate postoperative pain following root canal obturation using two different endodontic sealers: a bioceramic (calcium silicate-based) sealer and a calcium hydroxide-based sealer. Postoperative pain is a common complication of root canal therapy and may influence patient satisfaction as well as perceived treatment success. The physical and chemical properties of root canal sealers may contribute to postoperative discomfort through their interaction with periapical tissues.

The study will be conducted at the Department of Operative Dentistry, HITEC-IMS Dental College over a period of six months to 1 year following institutional approval. A total sample size of 50 participants will be enrolled and randomly allocated into two parallel groups using a lottery method, with 25 participants assigned to each group. A single-blind design will be maintained, in which participants will be unaware of the sealer used.

All clinical procedures will be performed in a single visit by the same operator to minimize procedural variability. Following diagnosis and confirmation of pulp vitality, standard endodontic treatment will be carried out under local anesthesia and rubber dam isolation. Canal preparation will be performed using hand and nickel-titanium rotary instruments. Irrigation will be carried out using sodium hypochlorite and EDTA solutions, followed by saline as the final rinse. Canals will be dried using sterile paper points.

Obturation will be performed using a single-cone technique with a matching-taper gutta-percha cone coated with the assigned sealer. Participants in the experimental groups will receive either a bioceramic sealer or a calcium hydroxide-based sealer. Access cavities will be restored with glass ionomer cement, and occlusal reduction will be performed to minimize postoperative discomfort due to occlusal trauma. No postoperative medications will be prescribed.

Postoperative pain will be evaluated using a Visual Analog Scale (VAS) at predefined time intervals following obturation. Analgesic intake, if any, will also be recorded to support accurate interpretation of pain outcomes.

Collected data will be entered into a spreadsheet and analyzed using statistical software. Comparative analysis of postoperative pain scores between the two groups at different time intervals will be performed using appropriate statistical tests.

Participant confidentiality will be maintained throughout the study. All collected data will be anonymized and used exclusively for research purposes.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Beenish Qureshi, BDS, FCPS
  • Phone Number: +92 333 4368332

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan
        • Recruiting
        • Department of Operative Dentistry, HITEC-IMS Dental College
        • Contact:
        • Contact:
          • Beenish Qureshi, BDS, FCPS
          • Phone Number: +92 333 4368332

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-40 years
  • Single-rooted permanent teeth
  • Teeth diagnosed with symptomatic irreversible pulpitis
  • Normal periapical condition on radiographic examination or periodontal ligament (PDL) space widening
  • Restorable teeth

Exclusion Criteria:

  • Patients with systemic conditions that could alter the course of treatment
  • Teeth with immature root development
  • Teeth with necrotic pulp
  • Teeth exhibiting root resorption
  • Teeth with calcified root canals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bioceramic Sealer Group
Participants in this group will receive root canal obturation using bioceramic (calcium silicate-based) sealer (CeraSeal) following standard endodontic procedures. After proper anesthesia and rubber dam isolation, the canals will be prepared, irrigated, and dried. A single-cone obturation technique will be used to place the sealer and gutta-percha. The cavities will be sealed with glass ionomer cement, and patients will record postoperative pain using the Visual Analog Scale (VAS) at 12, 24, 48, and 72 hours.
Procedure: CeraSeal Bioceramic Sealer
Participants will receive root canal obturation using CeraSeal Bioceramic Sealer. The sealer will be applied with a matching-taper gutta-percha cone using the single-cone technique after standard canal preparation and irrigation. The cavity will be sealed with glass ionomer cement. Postoperative pain will be recorded by participants using a Visual Analog Scale (VAS) at 12, 24, 48, and 72 hours.
Experimental: Calcium Hydroxide Sealer
Participants in this group will receive root canal obturation using calcium hydroxide-based sealer (Sealapex) following the same standard endodontic procedures as Arm 1. Postoperative pain will be measured using the VAS at 12, 24, 48, and 72 hours.
Procedure: Sealapex Calcium Hydroxide Sealer
Participants will receive root canal obturation using Sealapex Calcium Hydroxide Sealer applied with a matching-taper gutta-percha cone using the single-cone technique after standard canal preparation and irrigation. Cavities will be sealed with glass ionomer cement. Postoperative pain will be recorded by participants using the VAS at 12, 24, 48, and 72 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Following Root Canal Obturation
Time Frame: 12, 24, 48, and 72 hours after root canal obturation
Postoperative pain will be measured at 12, 24, 48, and 72 hours following root canal obturation. Pain intensity will be assessed using a Visual Analog Scale (VAS), where 0 represents "no pain," 1-3 indicates mild pain, 4-6 moderate pain, and 7-10 severe pain. Patients will record their pain scores at each time point, and any use of analgesics will also be documented to ensure accurate assessment.
12, 24, 48, and 72 hours after root canal obturation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HITEC-Institute of Medical Sciences

Investigators

  • Principal Investigator: Monal Fatima, HITEC-IMS, Department of Operative Dentistry, Taxila, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 7, 2026

First Submitted That Met QC Criteria

February 7, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • HITEC-IMS-ENDO-RCT-2025

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. All data collected will be kept strictly confidential, anonymized, and used only by the research team for analysis and reporting of study results. No identifiable patient information will be made publicly available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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