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

Sponsor
Pakistan Institute of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT06013293
Collaborator
(none)
100
1
2
11
9.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Zinc oxide eugeonal based sealer
  • Procedure: Resin Based Sealer
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Evalution of Postoperative Pain With Resin Based Sealer vs Zinc Oxide Eugenol Sealer After Single Visit Endodontic
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Post operative pain [immediately after the procedure]

    . Postoperative Visual analogue pain scores will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Dentistry Islamabad Pakistan 0920

Sponsors and Collaborators

  • Pakistan Institute of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahsen amin, Principal investigator, Pakistan Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT06013293
Other Study ID Numbers:
  • SOD/ERB/2023/19
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2023