Comparison of Post-Operative Endodontic Pain Using Sodium Hypochlorite, Hydrogen Peroxide, and Normal Saline as Root Canal Irrigants (EPI-RCT)

March 17, 2026 updated by: Rida Munir, CMH Multan Institute of Medical Sciences

Comparison of Endodontic Pain With Sodium Hypochlorite, Hydrogen Peroxide and Normal Saline Based Root Canal Irrigants

Pain is the main reason patients visit a dentist for root canal treatment. Sometimes, patients experience pain between visits, which can make the treatment uncomfortable and stressful. This study aims to compare three commonly used root canal irrigants-sodium hypochlorite, hydrogen peroxide, and normal saline-to see which one causes less pain after treatment.

Patients with acute pulpitis who require root canal treatment will be randomly assigned to one of the three irrigant groups. Pain will be measured using a simple Visual Analog Scale (VAS) at specific time points after treatment.

The results of this study will help dentists choose the most effective and comfortable irrigant, improving patient experience and reducing the likelihood of unscheduled visits due to pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Root canal treatment (RCT) is performed to relieve dental pain and eliminate infection within the tooth. The procedure involves mechanical cleaning and shaping of the root canal system, chemical irrigation to remove bacteria and tissue remnants, and sealing of the canals along with restoration of the coronal portion. Treatment is often done over multiple visits, with temporary fillings and medicaments placed between appointments.

Post-treatment pain is common in the inter-appointment period and may be caused by factors such as leakage of irrigants beyond the apex, improper instrumentation, remaining bacteria, endodontic flare-ups, or host-related factors. Chemical irrigation is used alongside mechanical cleaning to reduce microbial load and prevent post-treatment pain.

Irrigants studied:

Sodium hypochlorite (NaOCl): Strong antimicrobial properties, effective in dissolving pulp tissue, but can cause tissue irritation, swelling, and pain if extruded beyond the root apex.

Hydrogen peroxide (H2O2): Helps remove debris physically and has some antimicrobial activity, though its efficacy against bacteria is less well established. Can cause tissue irritation if misused.

Normal saline: Biologically safe but lacks antimicrobial activity. This study is designed as a randomized controlled trial to compare the incidence and intensity of post-endodontic pain in patients receiving these three irrigants in a local clinical setting.

Objective:

To compare post-endodontic pain among patients receiving sodium hypochlorite, hydrogen peroxide, and normal saline as root canal irrigants.

Operational Definitions:

Pain: Assessed using the Visual Analog Scale (VAS). VAS = 0 indicates no pain; VAS ≥ 1 indicates presence of pain.

Acute pulpitis: Diagnosed in patients with VAS pain score ≥ 4, tooth sensitivity on percussion, and radiographic evidence of lamina dura discontinuation or apical radiolucency.

Study Procedures:

Patients will be screened for eligibility. Eligible patients will be randomly assigned to one of three groups: NaOCl, H2O2, or normal saline.

Standard root canal treatment will be performed by trained clinicians. Pain assessment will be recorded at predetermined time points using VAS. Data will be collected, analyzed, and compared between groups to determine which irrigant results in the least post-treatment pain.

Study Type

Interventional

Enrollment (Actual)

90

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

  • Pakistan
      • Multan Khurd, Pakistan
        • CMH Multan

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

Yes

Description

Inclusion Criteria:

Male or female patients aged 18-50 years. Diagnosed with acute pulpitis with pain duration ≤ 3 days. Planned to undergo root canal treatment. Willing to provide informed consent and comply with follow-up.

Exclusion Criteria:

Teeth presenting with fluctuant facial swelling (acute apical abscess). Teeth with difficult access opening or instrumentation (e.g., malposed teeth). Presence of vertical tooth fracture (root canal treatment contraindicated). Patients with systemic conditions contraindicating dental treatment. Patients currently taking analgesics or antibiotics that may affect pain assessment.

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: Sodium Hypochlorite Irrigant Group
Participants in this group will receive standard root canal treatment using 2.5% sodium hypochlorite as the root canal irrigant. Pain will be assessed at specified intervals after the procedure using the Visual Analog Scale (VAS).
Drug: Sodium Hypochlorite 2.5%
Sodium hypochlorite 2.5% will be used as the root canal irrigant during standard root canal treatment. The solution will be applied throughout the mechanical cleaning and shaping of the canals. Pain will be assessed post-procedure using the Visual Analog Scale (VAS).
Experimental: Hydrogen Peroxide Irrigant Group
Participants in this group will receive standard root canal treatment using 3% hydrogen peroxide as the root canal irrigant. Pain will be assessed at specified intervals after the procedure using the Visual Analog Scale (VAS).
Drug: Hydrogen Peroxide
Hydrogen peroxide 3% will be used as the root canal irrigant during standard root canal treatment. The solution will be applied throughout the mechanical cleaning and shaping of the canals. Pain will be assessed post-procedure using the Visual Analog Scale (VAS).
Experimental: Normal Saline Irrigant Group
Participants in this group will receive standard root canal treatment using normal saline as the root canal irrigant. Pain will be assessed at specified intervals after the procedure using the Visual Analog Scale (VAS).
Drug: Normal Saline (0.9% NaCl)
Normal saline (0.9% sodium chloride solution) will be used as the root canal irrigant during standard root canal treatment. The solution will be applied throughout the mechanical cleaning and shaping of the canals. Pain will be assessed post-procedure using the Visual Analog Scale (VAS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: 72 hours after root canal treatment
Post-operative pain will be measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst possible pain. Pain scores will be recorded at follow-up and compared across the three irrigant groups to determine differences in post-endodontic pain intensity.
72 hours after root canal treatment

Collaborators and Investigators

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

Sponsor

CMH Multan 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)

March 15, 2025

Primary Completion (Actual)

November 13, 2025

Study Completion (Actual)

November 24, 2025

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMHMultan

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.

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