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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013293
• Other study ID #: SOD/ERB/2023/19
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2023
• Source: Pakistan Institute of Medical Sciences
• Contact: Ahsen Amin, BDS
• Phone: 03315161642
• Email: ahsen_amin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
Pakistan	School of Dentistry	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain	. Postoperative Visual analogue pain scores will be recorded	immediately after the procedure