Influence of Sealer Composition on Post-Endodontic Pain

August 11, 2026 updated by: Nourhan Rabie Ahmed, Minia University

Influence of Sealer Composition on Post-Endodontic Pain: A Prospective Comparative Analysis of Three Root Canal Sealers

Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life.

The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life .

The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week . The pathophysiology of postoperative pain involves mechanical, chemical, or microbial injury to the periapical tissues, which triggers an acute inflammatory response characterized by the release of inflammatory mediators, vasodilation, increased vascular permeability, and leukocyte migration, ultimately activating sensory neurons and generating pain.

The etiology of PP is multifactorial, including patient-related factors such as age, gender, tooth type particularly mandibular molars preoperative pain, and periapical radiolucency, as well as treatment-related factors such as instrumentation protocol, irrigation solution, working length determination, occlusal adjustment, number of visits, anesthesia type, and prophylactic analgesics. Understanding these variables allows clinicians to select techniques and materials that minimize postoperative discomfort.

Root canal obturation plays a critical role in postoperative pain, as sealers may come into direct contact with periradicular tissues or extrude through the apical foramen, eliciting cytotoxic and inflammatory responses . The chemical composition and biocompatibility of the sealer influence tissue reaction, periapical healing, and subsequent pain perception.

Traditionally, epoxy resin-based sealers, such as AH Plus®, have been considered the gold standard due to their excellent sealing properties, radiopacity, dimensional stability, and clinical performance; however, extrusion of these sealers has been associated with cytotoxicity and inflammation.

Calcium hydroxide-based sealers have long been used in endodontics, providing antibacterial effects, low cytotoxicity, and osteogenic and cementogenic potential, contributing to periapical repair.

More recently, calcium silicate-based bioceramic sealers, including tricalcium silicate formulations like BioRoot and EndoSeal MTA, have gained popularity due to their bioactivity, biocompatibility, ability to set in humid conditions, alkaline pH, calcium ion release, antimicrobial properties, and promotion of tissue regeneration with lower inflammatory mediator production.

These properties suggest that bioceramic sealers may reduce postoperative pain compared to traditional sealers, while supporting enhanced periapical healing and osteogenic induction.

Despite studies evaluating postoperative pain with different sealers, results remain controversial, and there is limited evidence specifically comparing the effects of epoxy resin-based versus calcium silicate-based sealers on pain outcomes following single-visit endodontic treatment.

This highlights a need for further randomized clinical trials to assess the incidence and severity of postoperative pain associated with these materials, particularly in patients with varying pulpal and periapical conditions.

Study Type

Interventional

Enrollment (Estimated)

66

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

Study Locations

  • Egypt
      • Minya, Egypt
        • Recruiting
        • Endodontics Department Faculty of Dentistry
        • Contact:

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 requiring primary root canal treatment.
  • Patients with acute irreversible pulpitis.
  • Patients in good general health

Exclusion Criteria:

  • Patients with systemic diseases affecting pain perception or healing.
  • Patients who had taken analgesics or antibiotics within 12-24 hours prior to treatment.
  • Pregnant or lactating women.
  • Previously treated teeth or teeth with root resorption, fractures, or severe periodontal disease

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (Calcium Hydroxide-based Sealer: Sealapex):

About 22 cases will be subjected to:

  1. Canals will be dried using sterile paper points, avoiding excessive desiccation to maintain optimal canal conditions prior to sealer placement.
  2. The sealer will be dispensed according to the manufacturer's instructions. Gutta-percha master cones will be lightly coated with the sealer and inserted to the full working length. Additional sealer may be applied into the canal using a lentulo spiral or an appropriate intracanal delivery tip when indicated.
  3. Accessory gutta-percha cones will be inserted into each canal to fill the spaces created by the spreader using a lateral compaction technique.
  4. After achieving optimal obturation of the canal, excess gutta-percha will be seared off at the canal orifices using a heated instrument.
  5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet moistened with saline.
Procedure: Calcium Hydroxide-based Sealer
to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.
Other Names:
  • Bioceramic Sealer and Resin-based Sealer
Active Comparator: Group B (Bioceramic Sealer: Well-Root):

About 22 cases will be subjected to:

  1. Canals will be dried using sterile paper points, avoiding over drying to maintain slight moisture within the dentinal tubules, which is favorable for the setting reaction of the bioceramic sealer.
  2. The premixed bioceramic sealer will be dispensed directly into the canal using the manufacturer's intracanal delivery tip adjusted to 1-2 mm short of the working length, or applied onto the master gutta-percha cone prior to insertion.
  3. The master gutta-percha cone will be inserted to the full working length. Accessory cones will be placed when necessary using a lateral compaction technique to ensure complete canal obturation.
  4. After achieving optimal filling, excess gutta-percha will be seared off at the canal orifices using a heat carrier.
  5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet lightly moistened with saline.
Procedure: Calcium Hydroxide-based Sealer
to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.
Other Names:
  • Bioceramic Sealer and Resin-based Sealer
Active Comparator: Group C (Resin-based Sealer: ADSEAL):

About 22 cases will be subjected to:

  1. Canals will be dried thoroughly using sterile paper points to ensure a moisture-free environment suitable for resin-based sealer application.
  2. The resin-based sealer will be mixed according to the manufacturer's instructions and applied into the canal using a lentulo spiral or coated onto the master gutta-percha cone before insertion to the working length.
  3. Accessory gutta-percha cones will be inserted using a lateral compaction technique to achieve dense canal obturation.
  4. Excess gutta-percha will be removed at the canal orifices using a heated instrument after completion of obturation.
  5. The pulp chamber will be cleaned from excess sealer using a sterile cotton pellet moistened with alcohol or saline as recommended by the manufacturer.
Procedure: Calcium Hydroxide-based Sealer
to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.
Other Names:
  • Bioceramic Sealer and Resin-based Sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Endodontic Pain Intensity
Time Frame: 7 days
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 will indicate "no pain" and 10 will indicate "worst imaginable pain." Participants will be instructed to record their pain intensity at 6, 12, 24, 48, and 72 hours, and on the 7th day after treatment. All recorded pain scores will be collected for statistical analysis and comparison among the study groups
7 days

Collaborators and Investigators

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

Sponsor

Minia University

Investigators

  • Study Chair: Dalia Ali Ahmed Moukarab, Professor, Professor and Head of the Endodontics Department, Faculty 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)

April 14, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 14, 2027

Study Registration Dates

First Submitted

August 11, 2026

First Submitted That Met QC Criteria

August 11, 2026

First Posted (Actual)

August 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Post-Endodontic Pain

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.

Subscribe