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

Primary Health Care Corporation, Qatar

Status: Enrolling

Conditions: Asymptomatic Apical Periodontitis

Treatments: Combination Product: AH plus sealer; Combination Product: Bioceramic sealer

Study type: Interventional

Funder types: Other

Identifiers

NCT06543004

BUHOOTH-D-24-000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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

Treatment:

Combination Product: AH plus sealer

Intervention

Active Comparator group

Description:

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

Treatment:

Combination Product: Bioceramic sealer