Bioceramic Versus Epoxy Resin-Based Root Canal Sealer and Postoperative Pain After Warm Vertical Compaction

November 5, 2026 updated by: AZİZ ŞAHİN ERDOĞAN, Ataturk University

Comparison of the Effects of Epoxy Resin- and Bioceramic-Based Root Canal Sealers on Postoperative Pain in Root Canal Filling With Warm Vertical Compaction: A Randomized Clinical Trial

The goal of this clinical trial is to learn whether the type of root canal sealer affects pain after root canal treatment in adults aged 18 to 65 who need root canal treatment of a single-rooted upper front tooth with a non-vital (dead) pulp and no signs of infection around the root tip. The main questions it aims to answer are:

Does a bioceramic-based sealer (TotalFill BC Sealer HiFlow) cause a different level of pain after treatment than an epoxy resin-based sealer (AH Plus)? Does the need for pain medicine after treatment differ between the two sealers?

Researchers will compare the bioceramic-based sealer with the epoxy resin-based sealer, which is widely used as a standard reference material, to see if one causes less pain after the root canal is filled.

Participants will:

Receive root canal treatment of one tooth, filled with the warm vertical compaction technique using one of the two sealers, assigned by chance; participants will not know which sealer was used Rate their pain on a 0-100 scale at 6, 12, and 24 hours and on days 3, 5, and 7 after treatment Record whether and when they took pain medicine (paracetamol) Return for a check-up visit one week after treatment

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Postoperative pain is a common complication of root canal treatment, and the chemical composition of the root canal sealer has been proposed as one of the factors influencing its incidence and intensity. Epoxy resin-based AH Plus is widely regarded as the reference sealer, whereas calcium silicate-based bioceramic sealers have gained popularity because of their biocompatibility, alkaline pH and hydraulic setting properties. Clinical evidence comparing these sealers in terms of postoperative pain remains inconsistent, and data obtained with warm vertical compaction are limited.

Design: This is a prospective, randomized, active-controlled, parallel-group, single-center clinical trial conducted at the Department of Endodontics, Faculty of Dentistry, Ataturk University (Erzurum, Turkey). Asymptomatic single-rooted maxillary anterior teeth with a diagnosis of pulp necrosis and normal apical tissues (periapical index score ≤2) will be included. A total of 70 participants (35 per group) will be allocated to one of two groups: Group 1, TotalFill BC Sealer HiFlow (FKG Dentaire SA, Switzerland); Group 2, AH Plus (Dentsply Sirona). Allocation will be performed using a computer-generated randomization sequence (www.randomizer.org). Participants will be blinded to group allocation; because pain will be self-reported by the participants, outcome assessment will also be blinded. Due to the different handling properties of the sealers, the operator cannot be blinded.

Treatment protocol: All treatments will be performed by a single operator following a standardized protocol. After local anesthesia and rubber dam isolation, the access cavity will be prepared and the working length determined with an electronic apex locator. Root canals will be shaped with a rotary instrumentation system and irrigated with 2.5% sodium hypochlorite, followed by a final rinse with distilled water. After drying, the assigned sealer will be applied and the canal obturated with the warm vertical compaction technique in both groups. Preoperative clinical and radiographic findings, including the periapical index (PAI) score, will be recorded on a standardized form.

Outcome assessment: Participants will rate their pain on a 100-mm Visual Analogue Scale (VAS) at 6, 12 and 24 hours and on days 3, 5 and 7 after treatment. Paracetamol 500 mg will be recommended as rescue medication, and analgesic intake (yes/no, day and time) will be recorded. Participants will be clinically re-examined one week after treatment for percussion and palpation sensitivity, swelling and sinus tract.

Statistical analysis: Normality will be tested with the Shapiro-Wilk test. Between-group comparisons will be performed with the independent-samples t-test or Mann-Whitney U test, and categorical variables with the chi-square or Fisher's exact test. Changes in pain over time will be analyzed with repeated-measures ANOVA or the Friedman test, as appropriate. The level of significance will be set at p<0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:- Age between 18 and 65 years

  • Single-rooted permanent maxillary anterior tooth requiring root canal treatment
  • Diagnosis of pulp necrosis with normal apical tissues (asymptomatic, no acute pain or abscess)
  • Periapical index (PAI) score of 2 or lower
  • Systemically healthy (ASA I) and not using any medication or analgesics
  • Willing to participate and provided signed informed consent

Exclusion Criteria:- Systemic disease or pregnancy

  • Use of analgesics or antibiotics within the previous 48 hours
  • Symptomatic apical periodontitis, acute apical abscess, or teeth requiring retreatment
  • Root resorption
  • History of allergic reactions
  • Abnormal root canal morphology (fused, dilacerated, or C-shaped canals)
  • Periodontal pocket depth greater than 3 mm or tooth mobility
  • Root perforation or instrument separation during treatment
  • Loss of contact during the follow-up period
  • Inability to complete the VAS pain scale according to the instructions

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bioceramic Sealer Group

Root canal treatment completed in a single visit; root canal obturated with warm vertical compaction using gutta-percha and TotalFill BC Sealer HiFlow (FKG Dentaire SA, Switzerland).
Device: TotalFill BC Sealer HiFlow

A premixed calcium silicate-based bioceramic root canal sealer applied with gutta-percha using the warm vertical compaction technique.
Active Comparator: Epoxy Resin Sealer Group

Root canal treatment completed in a single visit; root canal obturated with warm vertical compaction using gutta-percha and AH Plus (Dentsply Sirona).
Device: AH Plus

An epoxy resin-based root canal sealer applied with gutta-percha using the warm vertical compaction technique.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
Time Frame: 6, 12 and 24 hours and 3, 5 and 7 days after root canal obturation

Pain intensity after root canal treatment will be self-reported by participants on a 100-mm Visual Analogue Scale (VAS), where 0 indicates "no pain" and 100 indicates "unbearable/most severe pain". Higher scores indicate more severe pain.
6, 12 and 24 hours and 3, 5 and 7 days after root canal obturation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analgesic Intake
Time Frame: Up to 7 days after root canal obturation

The number and proportion of participants who take rescue analgesic medication (paracetamol 500 mg) due to postoperative pain, together with the day and time of intake, will be recorded.
Up to 7 days after root canal obturation
Clinical Signs at One-Week Recall
Time Frame: 7 days after root canal obturation

The presence of tenderness to percussion, tenderness to palpation, swelling and sinus tract will be clinically assessed and recorded as present or absent.
7 days after root canal obturation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aziz Sahin Erdogan, DDS, PhD, Ataturk University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B.30.2.ATA.0.01.00/766
  • 2025/4 (Other Identifier: Ataturk University Clinical Research Ethics Committee)

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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