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

Last updated: November 20, 2024
Sponsor: Primary Health Care Corporation, Qatar
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Bioceramic sealer

AH plus sealer

Root canal sealer

Clinical Study ID

NCT06543004
BUHOOTH-D-24-000
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Permanent single rooted tooth 1-1 configuration and complete root development.

  • Requiring root canal treatment.

  • Diagnosed with Asymptomatic apical periodontitis, teeth asymptomatic, periapicalindex will exhibit an apical radiolucency.

  • Willing to Participate.

Exclusion

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 Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: Bioceramic sealer
Phase:
Study Start date:
October 28, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Primary Health Corporation

    Doha,
    Qatar

    Active - Recruiting

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