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

Official title

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.

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• post operative pain questionnaire [Time frame: assessed at 24 hours, 48 hours, and 7 days post-treatment.]

Secondary outcome measures (2)

• Intensity of postoperative pain [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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Qatar · 1 center

• Primary Health Corporation — Doha

Publications

• Tan HSG, Lim KC, Lui JN, Lai WMC, Yu VSH. Postobturation Pain Associated with Tricalcium Silicate and Resin-based Sealer Techniques: A Randomized Clinical Trial. J Endod. 2021 Feb;47(2):169-177. doi: 10.1016/j.joen.2020.10.013. Epub 2020 Oct 22. PMID 33098889
• Zamparini F, Lenzi J, Duncan HF, Spinelli A, Gandolfi MG, Prati C. The efficacy of premixed bioceramic sealers versus standard sealers on root canal treatment outcome, extrusion rate and post-obturation pain: A systematic review and meta-analysis. Int Endod J. 2024 Aug;57(8):1021-1042. doi: 10.1111/iej.14069. Epub 2024 Apr 12. PMID 38606520
• Khandelwal A, Jose J, Teja KV, Palanivelu A. Comparative evaluation of postoperative pain and periapical healing after root canal treatment using three different base endodontic sealers - A randomized control clinical trial. J Clin Exp Dent. 2022 Feb 1;14(2):e144-e152. doi: 10.4317/jced.59034. eCollection 2022 Feb. PMID 35173897
• Aslan T, Donmez Ozkan H. The effect of two calcium silicate-based and one epoxy resin-based root canal sealer on postoperative pain: a randomized controlled trial. Int Endod J. 2021 Feb;54(2):190-197. doi: 10.1111/iej.13411. Epub 2020 Oct 17. PMID 32929721

Identifiers

NCT: NCT06543004 · BUHOOTH-D-24-000

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗