Evaluation of Postoperative Pain With Resin Based Sealer vs Zinc Oxide Eugenol Based Sealer After Single Visit Endodontic

August 22, 2023 updated by: Ahsen amin, Pakistan Institute of Medical Sciences

Evalution of Postoperative Pain With Resin Based Sealer vs Zinc Oxide Eugenol Sealer After Single Visit Endodontic

The goal of root canal therapy is thorough disinfection and obturation of the root canal system in all its dimensions and promote periradicular tissue repair.This study was done to compare the postopertaive pain after single visit endodontics using resin based sealer and zinc oxide eugeonal sealer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A total of 100 patients requiring endodontic treatment for permanent molar in accordance with the inclusion and exclusion criteria will be selected for the study. The treatment and study design will be explained to the patients in their own comprehendible language and a written informed consent will be obtained from the voluntary patients who participated in the study. A cold test and electric pulp-test was used to assess pulp vitality. Based on clinical and radiographic findings, the patients diagnosis of irreversible pulpitis. Patients will be randomly divided into two groups Group A = resin based sealer and Group B = Zinc oxide eugenol sealer. Prior to treatment the patients will be instructed how to complete a visual analog scale (VAS) to determine their pain score. The VAS included a 10 cm straight horizontal line numbered at each centimeter with the following criteria.Local anesthetic with 2% lignocaine containi Local anesthetic with 2% lignocaine containing 1:80000 epinephrine will be administered to each patient after recording preoperative pain levels . A rubber dam will be applied. The endodontic access cavities will be prepared with endo access burs .Working length will be established with #10 K file and the root canal will be instrumented with one shape rotary system up to #25.6% under copious irrigation with 3% sodium hypochlorite and normal saline. Before obturation root canals will be final rinse with 5 ml of 17% EDTA solution. In both groups, the root canal will be dried with paper points and obturated using gutta-percha cones and Resin based sealer/zinc oxide eugenol sealer. Coronal access cavities will be restored with direct composite restorations using dentinal adhesives and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h to determine their post-operative pain.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patient who agree to participate in study
  2. ASA CLASSIFICATION 1or 2
  3. Minimum age of 18years old and maximum age of 65 years old
  4. Maxillary and Mandibular single rooted teeth included in the study
  5. Patient with symptomatic irreversible pulpitis with either normal apical tissue or symptomatic apical periodontitis.

Exclusion Criteria:

- 1. ASA Classification 3 to 5 2. Patient with immature apices and root resorption will be excluded from the study.

3. Severe periodontal problem. 4. Vertical or horizontal root fractures will be excluded from the study 5. Patients who will be already on analgesia within 24 hours excluded from study 6. Those requiring root canal treatment of two or more teeth ipsilaterally (since the pain caused by any of these teeth can result in false positive reading) will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zinc oxide eugenol based sealer
Root canal treatment will be performed in posterior teeth.In this group the root canal will be dried with paper points and obturated with using gutta-percha cones and zinc oxide eugenol sealer. Coronal access cavities will be restored with direct composite restorations using dentinal adhesives and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h to determine their post-operative pain.
Procedure: Zinc oxide eugeonal based sealer
Zinc oxide-eugenol (ZOE)- based preparations, which have been used in root canal obturation (RCO) for over a hundered years and are known for their antimicrobial activities.slight microleakage and zinc oxide-eugenol's superior antibacterial property,slight microleakage and concerning the lower cytotoxicity, the zinc oxide-eugenol (ZOE) sealer can be used for root canal obturation as an endodontic sealer.After root canal prepartion , the root canal will be dried with paper points and obturated using gutta-percha cones and zinc oxide eugenol sealer.
Active Comparator: Resin based sealer
Root canal treatment will be performed in posterior teeth.In this group the root canal will be dried with paper points and obturated with using gutta-percha cones and resin based sealer. Coronal access cavities will be restored with direct composite restorations using dentinal adhesives and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h to determine their post-operative pain.
Procedure: Resin Based Sealer
resin-based sealer used frequently as a gold standard for endodontic sealers, due to its good physicochemical properties and provide satisfactory adhesion interface with dentin radicular surface.After root canal preparation, the root canal will be dried with paper points and obturated using gutta-percha cones and Resin based sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: immediately after the procedure
. Postoperative Visual analogue pain scores will be recorded
immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

August 30, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOD/ERB/2023/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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