Effect of Two Different Concentrations of Sodium Hypochlorite on Post-Operative Pain Following Single-Visit Root Canal Treatment

NCT07618182 | Not Yet Recruiting

• 1 other identifier: SCD-ENDO-NaOCl-2026
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial aims to evaluate the effect of two different concentrations of sodium hypochlorite (2.5% and 5.25%) on post-operative pain following single-visit root canal treatment. A total of 116 participants requiring primary endodontic treatment will be randomly allocated into two groups according to irrigant concentration. Post-operative pain will be assessed using a 100-mm Visual Analog Scale at 6, 12, 24, and 48 hours after treatment. The study seeks to determine the concentration that provides optimal disinfection with minimal patient discomfort.

Conditions

Post Operative Pain, Acute

Keywords

Sodium Hypochlorite; Root Canal Treatment

Outcome Measures

Primary Outcomes (2)

• Post-Operative Pain Following Single-Visit Root Canal Treatment

  Assessment and comparison of post-operative pain intensity between the 2.5% sodium hypochlorite group and the 5.25% sodium hypochlorite group using a 100-mm Visual Analog Scale (VAS).

  At 6 hours, 12 hours, 24 hours, and 48 hours after completion of treatment.

• Post-Operative Pain Score

  Assessment of post-operative pain using a 100-mm Visual Analog Scale following single-visit root canal treatment.

  6 hours, 12 hours, 24 hours, and 48 hours after treatment

Study Arms (2)

2.5% Sodium Hypochlorite Group

EXPERIMENTAL

Participants undergoing single-visit root canal treatment using 2.5% sodium hypochlorite as the irrigation solution.

Drug: Sodium Hypochlorite Irrigation

5.25% Sodium Hypochlorite Group

ACTIVE COMPARATOR

Participants undergoing single-visit root canal treatment using 5.25% sodium hypochlorite as the irrigation solution.

Drug: Sodium Hypochlorite Irrigation

Interventions

Sodium Hypochlorite Irrigation DRUG

Participants undergoing single-visit root canal treatment will receive root canal irrigation using either 2.5% sodium hypochlorite or 5.25% sodium hypochlorite solution. Irrigation will be standardized by delivering 5 mL of the assigned solution per canal using a 30-gauge side-vented needle placed 2 mm short of the working length during chemo-mechanical preparation. The concentration of sodium hypochlorite will be the only variable between study groups.

2.5% Sodium Hypochlorite Group; 5.25% Sodium Hypochlorite Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18-60 years Systemically healthy individuals Permanent teeth with closed apices requiring primary root canal treatment Teeth diagnosed with symptomatic/asymptomatic irreversible pulpitis or pulpal necrosis Patients able to understand the Visual Analog Scale Patients willing to provide informed consent and complete follow-up

You may not qualify if:

• Uncontrolled systemic diseases Pregnant or breastfeeding women Allergy to sodium hypochlorite or local anesthetics Previously endodontically treated teeth Teeth with root resorption, vertical root fracture, or open apex Severe periodontal disease or mobility Use of analgesics, antibiotics, or anti-inflammatory drugs within previous 7 days

Sponsors & Collaborators

• College of Physicians and Surgeons Pakistan: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Asad Ullah post graduate trainee

CONTACT

+923451505838; drasadkhan14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident, Department of Operative Dentistry

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: July 5, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share