NCT07486245

Brief Summary

Pain is the main reason patients visit a dentist for root canal treatment. Sometimes, patients experience pain between visits, which can make the treatment uncomfortable and stressful. This study aims to compare three commonly used root canal irrigants-sodium hypochlorite, hydrogen peroxide, and normal saline-to see which one causes less pain after treatment. Patients with acute pulpitis who require root canal treatment will be randomly assigned to one of the three irrigant groups. Pain will be measured using a simple Visual Analog Scale (VAS) at specific time points after treatment. The results of this study will help dentists choose the most effective and comfortable irrigant, improving patient experience and reducing the likelihood of unscheduled visits due to pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

root canal treatmentendodontic painsodium hypochloritehydrogen peroxidenormal salinedental irrigants

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain

    Post-operative pain will be measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst possible pain. Pain scores will be recorded at follow-up and compared across the three irrigant groups to determine differences in post-endodontic pain intensity.

    72 hours after root canal treatment

Study Arms (3)

Sodium Hypochlorite Irrigant Group

EXPERIMENTAL

Participants in this group will receive standard root canal treatment using 2.5% sodium hypochlorite as the root canal irrigant. Pain will be assessed at specified intervals after the procedure using the Visual Analog Scale (VAS).

Drug: Sodium Hypochlorite 2.5%

Hydrogen Peroxide Irrigant Group

EXPERIMENTAL

Participants in this group will receive standard root canal treatment using 3% hydrogen peroxide as the root canal irrigant. Pain will be assessed at specified intervals after the procedure using the Visual Analog Scale (VAS).

Drug: Hydrogen Peroxide

Normal Saline Irrigant Group

EXPERIMENTAL

Participants in this group will receive standard root canal treatment using normal saline as the root canal irrigant. Pain will be assessed at specified intervals after the procedure using the Visual Analog Scale (VAS).

Drug: Normal Saline (0.9% NaCl)

Interventions

Sodium hypochlorite 2.5% will be used as the root canal irrigant during standard root canal treatment. The solution will be applied throughout the mechanical cleaning and shaping of the canals. Pain will be assessed post-procedure using the Visual Analog Scale (VAS).

Sodium Hypochlorite Irrigant Group

Hydrogen peroxide 3% will be used as the root canal irrigant during standard root canal treatment. The solution will be applied throughout the mechanical cleaning and shaping of the canals. Pain will be assessed post-procedure using the Visual Analog Scale (VAS).

Hydrogen Peroxide Irrigant Group

Normal saline (0.9% sodium chloride solution) will be used as the root canal irrigant during standard root canal treatment. The solution will be applied throughout the mechanical cleaning and shaping of the canals. Pain will be assessed post-procedure using the Visual Analog Scale (VAS).

Normal Saline Irrigant Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female patients aged 18-50 years. Diagnosed with acute pulpitis with pain duration ≤ 3 days. Planned to undergo root canal treatment. Willing to provide informed consent and comply with follow-up.

You may not qualify if:

  • Teeth presenting with fluctuant facial swelling (acute apical abscess). Teeth with difficult access opening or instrumentation (e.g., malposed teeth). Presence of vertical tooth fracture (root canal treatment contraindicated). Patients with systemic conditions contraindicating dental treatment. Patients currently taking analgesics or antibiotics that may affect pain assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Multan

Multan Khurd, Pakistan

Location

MeSH Terms

Interventions

Hydrogen PeroxideSaline Solution

Intervention Hierarchy (Ancestors)

PeroxidesOxidesAnionsIonsElectrolytesInorganic ChemicalsReactive Oxygen SpeciesFree RadicalsOxygen CompoundsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Pain scores will be recorded by an assessor blinded to the type of irrigant used to minimize bias. The participant and care provider will not be blinded due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three parallel groups (sodium hypochlorite, hydrogen peroxide, or normal saline) to receive standard root canal treatment. Outcomes (pain scores) will be measured at predefined time points after intervention to compare efficacy among groups.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 20, 2026

Study Start

March 15, 2025

Primary Completion

November 13, 2025

Study Completion

November 24, 2025

Last Updated

March 20, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations