Postoperative Pain After Single-Cone Root Canal Obturation Using Three Sealers (POP-RCT)

February 21, 2026 updated by: Tehran University of Medical Sciences

Comparative Analysis of Postoperative Pain in Symptomatic Irreversible Pulpitis Teeth Following Single Cone Obturation Using Three Different Sealers: A Randomized Clinical Trial

The goal of this clinical trial is to compare post-treatment pain after root canal therapy in adults with irreversible pulpitis using different root canal sealers. The study will also evaluate the need for pain medication after treatment.

The main questions this study aims to answer are:

Does the type of root canal sealer affect the intensity of pain after treatment?

Does the type of sealer influence the number of analgesic tablets taken by participants?

How does pain change over time after treatment with different sealers?

Researchers will compare two bioceramic sealers (EndoSeal TCS and NeoSeal) with a resin-based sealer (AH Plus) to determine their effects on post-endodontic pain.

Participants will:

Receive root canal treatment using one of the study sealers

Report their pain intensity at specific time points after treatment

Record the number of analgesic tablets taken during the follow-up period

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

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 Locations

  • Iran
      • Tehran, Iran, 1439955991
        • Tehran University of Medical Sciences, School of Dentistry

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

Yes

Description

Inclusion Criteria:

  • Age between 18 and 60 years
  • Adequate oral and dental hygiene
  • Prolonged positive response to cold test and electric pulp testing
  • Clinical diagnosis of symptomatic irreversible pulpitis and symptomatic apical periodontitis in a first or second molar (maxillary or mandibular)
  • Pulp exposure during caries removal accompanied by severe and profuse hemorrhage
  • No radiographic evidence of periapical lesions
  • Teeth with adequate restorative potential
  • Absence of periodontal disease

Exclusion Criteria:

  • Teeth that are non-restorable
  • Presence of endodontic-periodontal (endo-perio) lesions
  • Teeth with radiographic evidence of periapical lesions
  • Teeth with internal or external root resorption
  • Patients with systemic diseases classified as ASA II or higher
  • Patients with a history of migraine
  • Teeth with over-obturation or under-obturation greater than 2 mm from the radiographic apex
  • Patients taking anti-anxiety medications
  • Procedural duration exceeding two hours
  • Known allergy to materials used in root canal treatment, including local anesthetics

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EndoSeal TCS
Participants receive single-visit root canal treatment using the bioceramic sealer EndoSeal TCS with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals
Procedure: Endoseal TCS
Bioceramic, premixed calcium silicate-based root canal sealer used for obturation with the single-cone technique during root canal treatment
Experimental: NeoSealer
Participants receive single-visit root canal treatment using the bioceramic sealer NeoSealer with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals.
Procedure: Neosealer
Fast-setting calcium silicate-based bioceramic root canal sealer used for obturation with the single-cone technique during root canal treatment
Experimental: AH Plus
Participants receive single-visit root canal treatment using the resin-based sealer AH Plus with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals
Procedure: AH Plus
Epoxy resin-based root canal sealer used for obturation with the single-cone technique during root canal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Endodontic Pain Intensity
Time Frame: Pain will be assessed at 6, 12,18, 24, and 48 hours post-treatment

Pain intensity experienced by participants after root canal treatment will be measured using a Visual Analog Scale (VAS; 0-10 numeric rating scale), where:

0 = no pain

10 = worst imaginable pain

Higher scores indicate greater pain intensity (worse outcome).

Participants will also record the number of analgesic tablets consumed during the first 48 hours after treatment.

The maximum VAS pain score recorded during the first 48 hours will be considered the primary outcome
Pain will be assessed at 6, 12,18, 24, and 48 hours post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Consumption
Time Frame: Within 48 hours post-treatment
Total number of analgesic tablets consumed by participants during the first 48 hours after treatment
Within 48 hours post-treatment

Collaborators and Investigators

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

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Shole Ghabraei, Professor, Tehran university of medical science, school of dentistry
  • Principal Investigator: Hadi Assadian, Assistant Professor, Tehran university of medical science, school of dentistry

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)

June 8, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 21, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.TUMS.DENTISTRY.REC.1404.021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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