Acute PulpitisEPI-RCTNCT07486245
Comparison of Post-Operative Endodontic Pain Using Sodium Hypochlorite, Hydrogen Peroxide, and Normal Saline as Root Canal Irrigants
A study testing Sodium Hypochlorite 2.5%, Hydrogen Peroxide and Normal Saline (0.9% NaCl) in people with Acute Pulpitis and Post Endodontic Pain, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pulpitis, Post Endodontic Pain
- What is being tested?
- Sodium Hypochlorite 2.5%, Hydrogen Peroxide and Normal Saline (0.9% NaCl)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2025to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Endodontic Pain With Sodium Hypochlorite, Hydrogen Peroxide and Normal Saline Based Root Canal Irrigants
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.
Read the detailed description
Root canal treatment (RCT) is performed to relieve dental pain and eliminate infection within the tooth. The procedure involves mechanical cleaning and shaping of the root canal system, chemical irrigation to remove bacteria and tissue remnants, and sealing of the canals along with restoration of the coronal portion. Treatment is often done over multiple visits, with temporary fillings and medicaments placed between appointments.
Post-treatment pain is common in the inter-appointment period and may be caused by factors such as leakage of irrigants beyond the apex, improper instrumentation, remaining bacteria, endodontic flare-ups, or host-related factors. Chemical irrigation is used alongside mechanical cleaning to reduce microbial load and prevent post-treatment pain.
Irrigants studied:
Sodium hypochlorite (NaOCl): Strong antimicrobial properties, effective in dissolving pulp tissue, but can cause tissue irritation, swelling, and pain if extruded beyond the root apex.
Hydrogen peroxide (H2O2): Helps remove debris physically and has some antimicrobial activity, though its efficacy against bacteria is less well established. Can cause tissue irritation if misused.
Normal saline: Biologically safe but lacks antimicrobial activity. This study is designed as a randomized controlled trial to compare the incidence and intensity of post-endodontic pain in patients receiving these three irrigants in a local clinical setting.
Objective:
To compare post-endodontic pain among patients receiving sodium hypochlorite, hydrogen peroxide, and normal saline as root canal irrigants.
Operational Definitions:
Pain: Assessed using the Visual Analog Scale (VAS). VAS = 0 indicates no pain; VAS ≥ 1 indicates presence of pain.
Acute pulpitis: Diagnosed in patients with VAS pain score ≥ 4, tooth sensitivity on percussion, and radiographic evidence of lamina dura discontinuation or apical radiolucency.
Study Procedures:
Patients will be screened for eligibility. Eligible patients will be randomly assigned to one of three groups: NaOCl, H2O2, or normal saline.
Standard root canal treatment will be performed by trained clinicians. Pain assessment will be recorded at predetermined time points using VAS. Data will be collected, analyzed, and compared between groups to determine which irrigant results in the least post-treatment pain.
- Conditions
- Acute Pulpitis, Post Endodontic Pain
- Being tested
- Sodium Hypochlorite 2.5%, Hydrogen Peroxide, Normal Saline (0.9% NaCl)
- Keywords
- root canal treatment, endodontic pain, sodium hypochlorite, hydrogen peroxide, normal saline, dental irrigants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Hypochlorite 2.5%Drug
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).
Hydrogen PeroxideDrug
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).
Normal Saline (0.9% NaCl)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start15 Mar 2025
- Primary completion13 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Multan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rida Munir, CMH Multan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486245
- Sponsor's protocol ID
- CMHMultan
- Acronym
- EPI-RCT
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endodontic Pain With Sodium Hypochlorite, Hydrogen Peroxide and Normal Saline Based Root Canal Irrigants
- ClinicalTrials.gov ID
- NCT07486245
- Acronym / sponsor ID
- EPI-RCT / CMHMultan
- Conditions
- Acute Pulpitis, Post Endodontic Pain
- Keywords
- root canal treatment, endodontic pain, sodium hypochlorite, hydrogen peroxide, normal saline, dental irrigants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- CMH Multan Institute of Medical SciencesOther government
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Root canal treatment (RCT) is performed to relieve dental pain and eliminate infection within the tooth. The procedure involves mechanical cleaning and shaping of the root canal system, chemical irrigation to remove bacteria and tissue remnants, and sealing of the canals along with restoration of the coronal portion. Treatment is often done over multiple visits, with temporary fillings and medicaments placed between appointments.
Post-treatment pain is common in the inter-appointment period and may be caused by factors such as leakage of irrigants beyond the apex, improper instrumentation, remaining bacteria, endodontic flare-ups, or host-related factors. Chemical irrigation is used alongside mechanical cleaning to reduce microbial load and prevent post-treatment pain.
Irrigants studied:
Sodium hypochlorite (NaOCl): Strong antimicrobial properties, effective in dissolving pulp tissue, but can cause tissue irritation, swelling, and pain if extruded beyond the root apex.
Hydrogen peroxide (H2O2): Helps remove debris physically and has some antimicrobial activity, though its efficacy against bacteria is less well established. Can cause tissue irritation if misused.
Normal saline: Biologically safe but lacks antimicrobial activity. This study is designed as a randomized controlled trial to compare the incidence and intensity of post-endodontic pain in patients receiving these three irrigants in a local clinical setting.
Objective:
To compare post-endodontic pain among patients receiving sodium hypochlorite, hydrogen peroxide, and normal saline as root canal irrigants.
Operational Definitions:
Pain: Assessed using the Visual Analog Scale (VAS). VAS = 0 indicates no pain; VAS ≥ 1 indicates presence of pain.
Acute pulpitis: Diagnosed in patients with VAS pain score ≥ 4, tooth sensitivity on percussion, and radiographic evidence of lamina dura discontinuation or apical radiolucency.
Study Procedures:
Patients will be screened for eligibility. Eligible patients will be randomly assigned to one of three groups: NaOCl, H2O2, or normal saline.
Standard root canal treatment will be performed by trained clinicians. Pain assessment will be recorded at predetermined time points using VAS. Data will be collected, analyzed, and compared between groups to determine which irrigant results in the least post-treatment pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sodium Hypochlorite Irrigant Group | Experimental | Drug: Sodium Hypochlorite 2.5%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). |
| Hydrogen Peroxide Irrigant Group | Experimental | Drug: Hydrogen PeroxideParticipants 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). |
| Normal Saline Irrigant Group | Experimental | Drug: Normal Saline (0.9% NaCl)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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Hypochlorite 2.5%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). | Drug | Sodium Hypochlorite Irrigant Group |
| Hydrogen PeroxideHydrogen 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). | Drug | Hydrogen Peroxide Irrigant Group |
| Normal Saline (0.9% NaCl)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). | Drug | Normal Saline Irrigant Group |
Primary outcome
Post-operative pain
Time frame: 72 hours after root canal treatment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Hypochlorite 2.5%, Hydrogen Peroxide and Normal Saline (0.9% NaCl) in people with Acute Pulpitis and Post Endodontic Pain, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 72 hours after root canal treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.