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

NCT07618182 — Not applicable, Not yet recruiting, 116 participants, College of Physicians and Surgeons Pakistan

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

Registry	NCT07618182, acronym NaOCl-RCT
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	116 (Estimated)
Sponsor	College of Physicians and Surgeons Pakistan (Other)
Conditions	Post Operative Pain, Acute
Interventions	Sodium Hypochlorite Irrigation (Drug)
Dates	start 2026-07-05 (estimated), primary completion 2026-12-05 (estimated), completion 2026-12-30 (estimated), first posted 2026-06-01, last updated 2026-06-01

-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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
2.5% Sodium Hypochlorite Group	Experimental	Drug: Sodium Hypochlorite Irrigation	Participants undergoing single-visit root canal treatment using 2.5% sodium hypochlorite as the irrigation solution.
5.25% Sodium Hypochlorite Group	Active comparator	Drug: Sodium Hypochlorite Irrigation	Participants undergoing single-visit root canal treatment using 5.25% sodium hypochlorite as the irrigation solution.

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.

+Outcome measures

Primary outcomes

Post-Operative Pain Following Single-Visit Root Canal Treatment [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).
Post-Operative Pain Score [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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

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