Post Operative Pain, AcuteNaOCl-RCTNCT07618182
Effect of Two Different Concentrations of Sodium Hypochlorite on Post-Operative Pain Following Single-Visit Root Canal Treatment
A study testing Sodium Hypochlorite Irrigation in people with Post Operative Pain, Acute, run by College of Physicians and Surgeons Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Sodium Hypochlorite Irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Two Different Concentrations of Sodium Hypochlorite on Post-Operative Pain Following Single-Visit Root Canal Treatment: A Randomized Controlled 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.
Read the 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.
- Conditions
- Post Operative Pain, Acute
- Being tested
- Sodium Hypochlorite Irrigation
- Keywords
- Sodium Hypochlorite, Root Canal Treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Hypochlorite IrrigationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 2.5% Sodium Hypochlorite Group | Experimental | Participants undergoing single-visit root canal treatment using 2.5% sodium hypochlorite as the irrigation solution. Receives: Drug: Sodium Hypochlorite Irrigation |
| 5.25% Sodium Hypochlorite Group | Active comparator | Participants undergoing single-visit root canal treatment using 5.25% sodium hypochlorite as the irrigation solution. Receives: Drug: Sodium Hypochlorite Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 6 hours, 12 hours, 24 hours, and 48 hours after completion of treatment.
Post-Operative Pain Score
Assessment of post-operative pain using a 100-mm Visual Analog Scale following single-visit root canal treatment.
Measured: 6 hours, 12 hours, 24 hours, and 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start5 Jul 2026 (estimated)
- Primary completion5 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faiz ur rahman, College of Physicians and Surgeons Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618182
- Sponsor's protocol ID
- SCD-ENDO-NaOCl-2026
- Acronym
- NaOCl-RCT
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Concentrations of Sodium Hypochlorite on Post-Operative Pain Following Single-Visit Root Canal Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07618182
- Acronym / sponsor ID
- NaOCl-RCT / SCD-ENDO-NaOCl-2026
- Conditions
- Post Operative Pain, Acute
- Keywords
- Sodium Hypochlorite, Root Canal Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 5 Jul 2026 (estimated)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.5% Sodium Hypochlorite Group | Experimental | Drug: Sodium Hypochlorite IrrigationParticipants 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 IrrigationParticipants undergoing single-visit root canal treatment using 5.25% sodium hypochlorite as the irrigation solution. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 IrrigationParticipants 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. | Drug | 2.5% Sodium Hypochlorite Group, 5.25% Sodium Hypochlorite Group |
Primary outcome
Post-Operative Pain Following Single-Visit Root Canal Treatment
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 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.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Hypochlorite Irrigation in people with Post Operative Pain, Acute, run by College of Physicians and Surgeons 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: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asad Ullah post graduate trainee (+923451505838, drasadkhan14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Operative Pain Following Single-Visit Root Canal Treatment (time frame: At 6 hours, 12 hours, 24 hours, and 48 hours after completion of treatment.). The study lists 2 primary outcomes in all. 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 1 Jun 2026.