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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-28

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asymptomatic Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control Group

The control group will be treated by using Resin based sealer during obturation which will be selected at random.

Group Type ACTIVE_COMPARATOR

AH plus sealer

Intervention Type COMBINATION_PRODUCT

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.

Intervention

The comparator group will receive Bioceramic sealer during obturation as intervention which will be selected at random.

Group Type ACTIVE_COMPARATOR

Bioceramic sealer

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes