Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543004
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Comparison of the Effects of Bio Ceramic and Epoxy Resin-based Sealers on Postoperative Pain After Root Canal Treatment
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
MethodsDesign 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
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
MethodsDesign 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None