NCT07388368

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P75+ for not_applicable pain

Timeline
15mo left

Started Feb 2026

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Feb 2026Aug 2027

First Submitted

Initial submission to the registry

December 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 7, 2025

Last Update Submit

January 30, 2026

Conditions

Pain

Keywords

root canal sealarpostobturation painbioceramic sealerresin based sealar

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Tricalcium silicate based sealer (Bio ceramic)

ACTIVE COMPARATOR

CeraSeal bioceramic sealer will be used for obturation with matched bioceramic cones and a heated plugger (System B).

Drug: Tricalcium silicate sealar

Resin based sealer

EXPERIMENTAL

Endoplus resin-based sealer will be used for obturation with single-cone gutta-percha and a heated plugger (System B)

Drug: Resin based sealer

Interventions

Resin based sealerDRUG

Endoplus (resin-based sealer) - assigned to Group 1

Also known as: Endoplus sealer, resin sealer, gutta-percha sealer
Resin based sealer
Tricalcium silicate sealarDRUG

Ceraseal (bioceramic sealer) - assigned to Group 2

Also known as: CeraSeal sealer, bioceramic sealer, calcium silicate sealer
Tricalcium silicate based sealer (Bio ceramic)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Force Institute of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

epoxy resin-based root canal sealer

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Pooja Kumari

CONTACT

03133422793dhomejapooja@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A comparative evaluation of postobturation pain after root canal treatment using tricalcium silicate versus resin-based sealers in cases with symptomatic irreversible pulpitis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Pooja Kumari, Principal Investigator and Resident, Operative Dentistry and Endodontics

Study Record Dates

First Submitted

December 7, 2025

First Posted

February 5, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

PA(1)