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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCollege of Physicians and Surgeons Pakistan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: 2.5% Sodium Hypochlorite GroupExperimental treatment 1 intervention
Group B: 5.25% Sodium Hypochlorite GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
At 6 hours, 12 hours, 24 hours, and 48 hours after completion of treatment.
2

Post-Operative Pain Score

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

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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