Post Operative Sensitivity of MTA Obturation

December 27, 2025 updated by: Ayşe Tuğba Eminsoy Avcı, TC Erciyes University

Effects of Three Different Root Canal Filling Materials Used in Single-Session Root Canal Treatment on Postoperative Pain: A Randomized Clinical Study

The aim of this study was to investigate the difference in postoperative pain caused by different root canal sealers in patients with irreversible pulpitis symptoms and no apical lesions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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.
Observational

Enrollment (Actual)

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.
54

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

  • Turkey (Türkiye)
      • Kayseri, Turkey (Türkiye), 38000
        • Erciyes University Faculty 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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Systemically healthy patients between the ages of 18-65

Description

Inclusion Criteria:

  • asymptomatic tooth with delayed positive response to thermal tests and electric pulp tests
  • large pulp perforation during caries removal,
  • inflamed pulp in which bleeding could not be controlled within 5 min,
  • periodontally healthy mature mandibular first or second molar tooth.

Exclusion Criteria:

  • patients if they were diabetic, immunocompromised, pregnant,
  • had a positive history of antibiotic use during the past 1 month,
  • required antibiotic prophylaxis
  • used analgesic within 7 days prior to the beginning of treatment,
  • were allergic to the materials used during root canal treatment,
  • if the bleeding could be controlled within 5 min and vital pulp treatment could be performed,
  • the tooth had negative response to vitality tests and/or was symptomatic,
  • had an associated periapical lesion visible on a radiograph,
  • needed a post-core or was planned to serve as prosthetic support,
  • had a calcified root canal and internal or external root resorption,
  • had tooth with open apex
  • mandibular third molars

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
powder-liquid MTA
The root canal will be filled with MTA at the end of the first session and patients will fill out a post-op pain form for 1 week.
Drug: MTA
MTA is primarily composed of tricalcium silicate, dicalcium silicate, bismuth oxide (for radiopacity), and small amounts of calcium sulfate. MTA is highly biocompatible, making it suitable for use in the root canal system and areas in close contact with tissues.
Putty MTA
The root canal will be filled with putty MTA at the end of the first session and patients will fill out a post-op pain form for 1 week.
Drug: MTA
MTA is primarily composed of tricalcium silicate, dicalcium silicate, bismuth oxide (for radiopacity), and small amounts of calcium sulfate. MTA is highly biocompatible, making it suitable for use in the root canal system and areas in close contact with tissues.
Epoxy resin sealer
The root canal will be filled with epoxy resin sealer and gutta-percha at the end of the first session and patients will fill out a post-op pain form for 1 week.

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
7-day postoperative pain after root canal treatment
Time Frame: 7 days
At the end of the visit, patients were educated to record their postoperative pain level by assigning a number between 0 and 10 using the numerical rating scale (NRS) chart. They were categorized into four: 0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain. The patients were asked to record their pain level preoperatively, at 6, 12, and 24 h, and daily for up to 7 days, and return it to he investigators at a specific time.
7 days

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.
TC Erciyes 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 (Actual)

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.
January 30, 2025

Primary Completion (Actual)

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.
December 1, 2025

Study Completion (Actual)

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.
December 15, 2025

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).
December 22, 2024

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.
January 25, 2025

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.
January 28, 2025

Study Record Updates

Last Update Posted (Estimated)

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.
January 2, 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.
December 27, 2025

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.
December 1, 2025

More Information

Terms related to this study

Keywords

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.
  • AAvci

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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