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NCT Number: NCT07618182

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

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.

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Key information

About this study

This study will be conducted in the Department of Operative Dentistry, Saidu College of Dentistry, Swat. Sodium hypochlorite is widely regarded as the gold standard irrigant in endodontics because of its tissue dissolution and antimicrobial properties. However, its concentration-dependent cytotoxicity may influence post-operative pain after treatment.

A randomized controlled trial design will be used with two parallel groups receiving either 2.5% or 5.25% sodium hypochlorite during standardized single-visit root canal treatment. A total of 116 participants aged 18-60 years requiring primary root canal therapy will be recruited using consecutive sampling.

All procedures including anesthesia, access preparation, working length determination, instrumentation, irrigation protocol, and obturation will be standardized. Post-operative pain will be recorded using a 100-mm Visual Analog Scale at 6, 12, 24, and 48 hours post-treatment.

Data analysis will be performed using IBM SPSS Statistics. Repeated measures analysis will compare pain scores between groups across different time intervals. Statistical significance will be considered at p < 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Post-Operative Pain Following Single-Visit Root Canal Treatment

    Time frame: At 6 hours, 12 hours, 24 hours, and 48 hours after completion of 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).

  2. Post-Operative Pain Score

    Time frame: 6 hours, 12 hours, 24 hours, and 48 hours after treatment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Asad Ullah post graduate trainee

CONTACT

[email protected]

+923451505838

Sponsors and collaborators

Lead sponsor

College of Physicians and Surgeons Pakistan

Other

Registry information

Official study title

Effect of Two Different Concentrations of Sodium Hypochlorite on Post-Operative Pain Following Single-Visit Root Canal Treatment: A Randomized Controlled Trial

Acronym: NaOCl-RCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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