Comparison of the Effects of Bio Ceramic and Epoxy Resin-based Sealers on Postoperative Pain After Root Canal Treatment

November 20, 2024 updated by: Dareen Azzouz, Primary Health Care Corporation, Qatar

Comparison of the Effects of Bio Ceramic and Epoxy Resin-based Sealers on Postoperative Pain After Root Canal Treatment: A Randomized Controlled Trial at Primary Health Care Corporation, Qatar.

This study aims to compare the effect of bio ceramic sealer and resin-based sealer on the intensity and occurrence of post operative pain in single rooted teeth with asymptomatic apical periodontitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Root canal sealers are essential for the success of endodontic treatment. Their physical properties, biocompatibility, and interactions with peri-apical tissues directly affect postoperative pain and healing. Endodontic sealers activate trigeminal nociceptors, leading to the release of CGRP (calcitonin gene-related peptide), which causes pain and a neurogenic inflammatory response. Resin-based sealers are widely used in endodontics due to their superior physicochemical properties. However, they have limitations, including the need for a completely dry canal due to their marked hydrophobicity and their initial cytotoxic activity, which cannot be entirely controlled.

Bio-ceramic sealers represent a new generation of endodontic sealers that are favored by many dental professionals due to their small particle size (less than 2 micrometers), non-toxicity, high tissue compatibility, high hydrophilicity, and minimal dimensional changes. Retrospective studies have shown varying outcomes related to postoperative pain after root canal treatment using resin-based or bio-ceramic sealers.

Aim: This study aims to compare the occurrence and intensity of postoperative pain and analgesic intake after root canal treatment using two different types of root canal sealers.

Methods/Design: This study is a binary outcome randomized trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines for randomized trials of non-pharmacologic treatment. The study sample will consist of adult patients with a permanent single-rooted tooth diagnosed with asymptomatic apical periodontitis. Participants will be randomly allocated to be treated in the Endodontic clinic of PHCC Qatar with either resin-based sealers (control group) or bio-ceramic sealers (experimental group) to compare postoperative pain after root canal treatment.

Patients will be observed for occurrence of pain or any other complications at 24 hours, 48 hours, and 7 days post-treatment. Postoperative pain will be assessed using a visual analog scale (VAS) at 24 hours, 48 hours, and one week post-treatment.

Differences in the incidence of postoperative pain and the need for an analgesic will be analyzed using the chi-square test. Differences in pain intensity after treatment will be analyzed using the ordinal (linear) chi-square test.

Study Type

Interventional

Enrollment (Estimated)

40

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

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:

  • Permanent single rooted tooth 1-1 configuration and complete root development.
  • Requiring root canal treatment.
  • Diagnosed with Asymptomatic apical periodontitis, teeth asymptomatic, periapical index will exhibit an apical radiolucency.
  • Willing to Participate.

Exclusion Criteria:

  • Medically compromised patients.
  • Inability to reach working length, complication during treatment.
  • Retreatment teeth, multi rooted teeth.
  • Periodontological compromised teeth.
  • Uncooperative patients.
  • Pregnant patients.

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
Active Comparator: Control Group
The control group will be treated by using Resin based sealer during obturation which will be selected at random.
Combination product: AH plus sealer
Root canal sealer will be placed inside the root canals during obturation procedure to seal dentine wall and reinforce the remaining tooth tissue.It will be selected randomly to the study samples.
Active Comparator: Intervention
The comparator group will receive Bioceramic sealer during obturation as intervention which will be selected at random.
Combination product: Bioceramic sealer
Root canal sealer will be placed inside the root canals during obturation procedure to seal dentine wall and reinforce the remaining tooth tissue.It will be selected randomly to the study samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative pain questionnaire
Time Frame: assessed at 24 hours, 48 hours, and 7 days post-treatment.
The participants of the study groups will be given a questionnaire to record whether they experienced pain following the root canal treatment after applying each type of the study sealers or no, during the Time frame.
assessed at 24 hours, 48 hours, and 7 days post-treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of postoperative pain
Time Frame: assessed at 24 hours, 48 hours, and 7 days post-treatment.
The patient will be asked to measure Intensity of their postoperative pain using a Visual Analog Scale. It consist of a straight line, usually 10 centimeters in length, with end point defining the extremes of pain. One end of the line represents no pain(usually marked as 0), while the other end represents' worst imaginable pain' (usually marked as 10) participant mark a point on the line that corresponds to their perceived pain intensity. The distance from the 'no pain' end to the mark is then measured and used to quantify the pain level during Time frame.
assessed at 24 hours, 48 hours, and 7 days post-treatment.
Analgesic
Time Frame: assessed at 24 hours, 48 hours, and 7 days post-treatment.
Analgesic intake recorded, The participants of the study will be asked to record any analgesic taken and the number of the tables during the Time frame.
assessed at 24 hours, 48 hours, and 7 days post-treatment.

Collaborators and Investigators

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

Sponsor

Primary Health Care Corporation, Qatar

Investigators

  • Principal Investigator: Dareen Azzouz, Primary Health Care Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 28, 2024

Primary Completion (Estimated)

October 27, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUHOOTH-D-24-000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A password protected computer system is used to assure secure data storage.Only encrypted systems are used for storing research data on laptops. A locked file cabinet is used to store research related paper forms.Access to study data is limited to only a few members of the study team.Plans are set to destroy all research generated data after 3 years according to PHCC regulations.The study report / publication will show only aggregate results with no identifiers.

Only deidentified study data is stored. A code number is used instead of the participant's real name on study data and blood/tissue samples.

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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