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

Not Applicable

Recruiting

• Conditions: Asymptomatic Apical Periodontitis
• Interventions: Combination Product: Root canal sealer

• Registration Number: NCT06543004
• Lead Sponsor: Primary Health Care Corporation, Qatar

Brief 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.

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 Timeline

• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-08-03
• Study First Posted: 2024-08-07
• Study Start: 2024-10-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-10-27
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Root canal sealer	The comparator group will receive Bioceramic sealer during obturation as intervention which will be selected at random.
Control Group	Root canal sealer	The control group will be treated by using Resin based sealer during obturation which will be selected at random.

Primary Outcome Measures

Name	Time	Method
post operative pain questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Analgesic	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.
Intensity of postoperative pain	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.

Trial Locations

Locations (1)

Primary Health Corporation; 🇶🇦 Doha, Qatar