NCT07486245

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: CMH Multan Institute of Medical Sciences · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Acute Pulpitis
• Post Endodontic Pain

Interventions

Type	Name	Description
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).
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).
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).

Timeline

• Start date: 2025-03-15
• Primary completion: 2025-11-13
• Completion: 2025-11-24
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: Pakistan