The Effect of Commercial and Medical Grade Sodium Hypochlorite on Post Endodontic Pain

December 28, 2025 updated by: Maha Nasr, Cairo University

Postoperative Pain After Single Visit Root Canal Treatment Using Commercial or Medical Grade Sodium Hypochlorite as Irrigating Solutions in Patients With Symptomatic Irreversible Pulpitis in Their Mandibular Molars: A Randomized Controlled Trial

the aim of the current study is to evaluate the effects of commercial and medical formulations of NaOCl on postoperative pain after endodontic treatment of mandibular posterior teeth with acute irreversible pulpitis.

Personal data including name, address, and phone number in addition to medical history and dental history will be collected by the operator from each patient in specific forms, then history of chief complaint will be recorded. The selected patients should show symptoms of irreversible pulpitis. The operator will perform extra-oral and intra-oral clinical examination as the expected tooth to be included in this study should be examined tentatively using a diagnostic mirror and probe. Radiograph will be taken to help to identify if there is widening of periodontal ligament space, periapical radiolucency, deep caries near the pulp chamber or recurrent caries under restoration.

The diagnosis of symptomatic irreversible pulpitis is confirmed through the patients' history of moderate to severe pain with hot and/or cold in mandibular posterior area, prolonged exaggerated response to cold testing than the contralateral tooth and positive response to electric pulp tester. Radiograph should show no or slight widening of periodontal ligaments. After completing the diagnosis (symptomatic irreversible pulpitis) and confirming that the patient fulfills the eligibility criteria, the patient will be enrolled in the study. The treatment will be done in a single visit.

• Treatment procedure: Each patient will be given an NRS chart to rate her /his presenting pain as preoperative pain. After administering anesthesia, access cavity will be performed using round bur size 4 and Endo-Z bur (DENTSPLY, Tulsa Dental, DENTSPLY Maillefer, TN, USA), then the tooth will be isolated using rubber dam, at this point, patients will be randomly assigned to either of two groups according to the used irrigating solution, group 1, irrigation will be done using the professional form of NaOCl and group 2, irrigation will be done using the commercial form of NaOCl. Irrigant preparation will be done by a dentist who is not involved in the study so that the operator would be blind to the irrigant used. Working length will be determined by the apex locator (Root ZX, J.Morita USA, Irvine, USA) and radiographically confirmed as 0.5-1 mm shorter from the radiographic apex. Root canal treatment will be, then, completed using Edge X7 (Edge-Endo, USA) NiTi rotary files system according to the manufacturer instructions. All canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every two subsequent instruments. Canals will be dried then obturated by the modified single cone technique using 0.04 taper gutta percha points and epoxy resin sealer (ADSEAL, METABIOMED.CO., LTD, Korea) and then a spreader will be used to provide space for auxiliary cones. The access cavity will be then sealed with temporary filling (MD-TEMP, META BIOMED CO., LTD. Chungbuuk, Korea).

Patients will be referred to an operative or a fixed prosthodontics specialist for crown placement at the Faculty of Dentistry, Egyptian Russian University. Post-operative instructions and appropriate post-operative rescue medication will be prescribed (400mg Ibuprofen). All patients will be asked to record their postoperative pain level felt on NRS at 6, 12, 24, 48, 72 hours and 7 days.

Research objective (state the aim) The aim of this study is to assess the effect of different sodium hypochlorite preparations (commercial VS medical) on postoperative pain in patients with symptomatic irreversible pulpitis after single visit endodontic treatment.

Sample size:

Anticipated sample size, 60 patients will be included in the study, divided into 2 groups, 30 patients per group.

Grouping & Randomization used:(specify if present) Two groups Group 1: Professional NaOCl Group 2: Commercial NaOCl

Outcome variables:

The primary outcome is the effect on Postoperative pain which will be measured using NRS at 6, 12, 24, 48, 72 hours postoperatively. Numerical Rating Scale (NRS) (20): It is an 11-point scale consisting of numbers from 0 through 10; - 0 reading represents "no pain" - 1-3 readings represent "mild pain" - 4- 6 readings represent "moderate pain" - 7- 10 readings represent "severe pain"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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 Locations

  • Egypt
      • Cairo, Egypt, 4450113
        • Faculty of Dentistry, Cairo University
      • Cairo, Egypt, 4450113
        • Faculty of Oral and Dental Medicine, Egyptian Russian University

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Patients with symptomatic irreversible pulpitis. 2. Patients with active pain (moderate-to-severe) in mandibular molars. 4. Males and females. 5. Patient with the ability to understand and use pain scales. 6. Patient who accepts to enroll to the study.

Exclusion Criteria:

  • 1. Pregnant females. 2. Patients taking pain medication 12 hours earlier. 3. Patient having more than one symptomatic mandibular tooth in the same quadrant.

    4. Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.

    5. Patients with contributory medical history (ASA>II).

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Commercial NaOCl
Drug: commercially available Sodium Hypochlorite
during the routine root canal treatment of mandibular molars with SIP, irrigation will be performed between each two successive files with 2 ml of half concentration commercially available sodium hypochlorite and after complete preparation 5 ml of the same solution will be used in full concentration for the purpose of smear layer removal.
Experimental: Medical Grade NaOCl
Drug: Medical grade Sodium Hypochlorite
during the routine root canal treatment of mandibular molars with SIP, irrigation will be performed between each two successive files with 2 ml of half concentration Medical grade sodium hypochlorite and after complete preparation 5 ml of the same solution will be used in full concentration for the purpose of smear layer removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative pain
Time Frame: from enrollemnt to 72 hours after treatment
incidence and intensity of post operative pain after single visit root canal treatment of mandibular molars with SIP
from enrollemnt to 72 hours after treatment

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 27, 2025

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ERU3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Symptomatic Irreversible Pulpitis (SIP)

Clinical Trials on commercially available Sodium Hypochlorite

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe