Clinical trial NCT06543004: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asymptomatic Apical Periodontitis
Keywords: Bioceramic sealer
Resin based sealer
Lead sponsor: Primary Health Care Corporation, Qatar
Sponsor class: OTHER_GOV
First posted: 2024-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: post operative pain questionnaire
timeFrame: assessed at 24 hours, 48 hours, and 7 days post-treatment.
Secondary outcomes:
measure: Intensity of postoperative pain
timeFrame: assessed at 24 hours, 48 hours, and 7 days post-treatment.
measure: Analgesic
timeFrame: assessed at 24 hours, 48 hours, and 7 days post-treatment.
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Primary Health Corporation
Study officials:
affiliation: Primary Health care corporation
name: Dareen Azzouz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.