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

NCT07410780 | Recruiting DMC

• 1 other identifier: HITEC-IMS-ENDO-RCT-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Following 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

Study Arms (2)

Bioceramic Sealer Group

EXPERIMENTAL

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

Calcium Hydroxide Sealer

EXPERIMENTAL

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

Interventions

CeraSeal Bioceramic Sealer PROCEDURE

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.

Bioceramic Sealer Group

Sealapex Calcium Hydroxide Sealer PROCEDURE

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.

Calcium Hydroxide Sealer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HITEC-Institute of Medical Sciences: lead

Study Sites (1)

Department of Operative Dentistry, HITEC-IMS Dental College

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Related Links

• The Effects of Calcium Silicate- and Calcium Hydroxide-based Root Canal Sealers on Postoperative Pain: A Randomized Clinical Trial

Study Officials

• Monal Fatima

  HITEC-IMS, Department of Operative Dentistry, Taxila, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monal Fatima, BDS

CONTACT

03004410676; manalfatima1100@gmail.com

Beenish Qureshi, BDS, FCPS

CONTACT

+92 333 4368332

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Part II Trainee, Operative Dentistry and Endodontics

Model Details: Participants will be randomly assigned to one of two groups: Group A, receiving bioceramic sealer, or Group B, receiving calcium hydroxide sealer. Each participant will remain in their assigned group for the duration of the study, and postoperative pain will be measured at 12, 24, 48, and 72 hours.

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: February 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)