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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07618182
Acronym
NaOCl-RCT
Enrollment
116
Registered
2026-06-01
Start date
2026-07-05
Completion date
2026-12-30
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain, Acute

Keywords

Sodium Hypochlorite, Root Canal Treatment

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.

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.

Interventions

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.

Sponsors

College of Physicians and Surgeons Pakistan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-Operative Pain Following Single-Visit Root Canal TreatmentAt 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 Score6 hours, 12 hours, 24 hours, and 48 hours after treatmentAssessment of post-operative pain using a 100-mm Visual Analog Scale following single-visit root canal treatment.

Contacts

CONTACTAsad Ullah post graduate trainee
drasadkhan14@gmail.com+923451505838

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026