Postoperative PainCHXvsNaOCl-PaiNCT07453160
Comparing Two Root Canal Cleaning Solutions (Chlorhexidine vs. Sodium Hypochlorite) for Pain After Treatment
A study testing Chlorhexidine gluconate 2% and Sodium hypochlorite 5.25% in people with Postoperative Pain, run by College of Physicians and Surgeons Pakistan.
Trial summary
Brief Summary (A short description for the lay public) This study aims to find out if the type of cleaning solution used during a root canal affects the pain a patient feels the next day. A root canal procedure involves cleaning the inside of the tooth. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Chlorhexidine gluconate 2% and Sodium hypochlorite 5.25%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Jun 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
- Adults aged 18-65 years
- Any gender
- Requiring non-surgical root canal treatment
- Willing to provide written informed consent
- Able to report postoperative pain using a validated pain assessment scale -
- Exclusion Criteria:Known hypersensitivity or allergy to chlorhexidine or sodium hypochlorite
Show all 13Show fewer
- Systemic conditions affecting pain perception (e.g., diabetes with neuropathy, fibromyalgia)
- Medications affecting pain perception (e.g., chronic analgesics, corticosteroids, antidepressants)
- Preoperative dental pain in the tooth scheduled for treatment
- Pregnancy or lactation
- Teeth with resorbed roots
- Mobile teeth (pathological mobility)
- Open apices
Who cannot join
None listed.
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: Comparison of Postoperative Pain Using 2% Chlorhexidine Versus 5.25% Sodium Hypochlorite as Root Canal Irrigants in Non-surgical Root Canal Treatment: A Randomized Controlled Trial
Brief Summary (A short description for the lay public)
This study aims to find out if the type of cleaning solution used during a root canal affects the pain a patient feels the next day. A root canal procedure involves cleaning the inside of the tooth. Two common cleaning solutions are chlorhexidine (CHX) and sodium hypochlorite (NaOCl, also known as bleach). While both are effective, it is not clear if one causes more discomfort than the other.
In this research, half of the participants will have their root canal cleaned with CHX, and the other half with NaOCl. We will then ask all participants to rate their pain 24 hours after the procedure using a simple pain scale. Our goal is to see if there is a difference in pain levels between the two groups. The results will help dentists choose the best solution to make their patients more comfortable after treatment
Read the detailed description
Detailed Description (Extended technical description of the protocol)
This study is designed as a randomized controlled trial to compare the intensity of postoperative pain 24 hours after non-surgical root canal treatment using two different irrigating solutions: 2% chlorhexidine (CHX) and 5.25% sodium hypochlorite (NaOCl). The central hypothesis is that the type of irrigant influences early postoperative pain, but that this effect may be modified by patient-specific factors such as gender and age.
Methodology:
Following ethical approval and informed consent, 90 adult patients indicated for non-surgical root canal treatment will be enrolled using a non-probability consecutive sampling technique. Participants will be randomly allocated to one of two parallel groups (n=45 per group): Group A (2% CHX) and Group B (5.25% NaOCl). The sample size was calculated a priori using the pwr package in R, assuming a 95% confidence level, 80% power, and a moderate effect size based on previous studies.
A standardized endodontic protocol will be followed for all participants to ensure consistency and minimize bias:
Procedure: After administering local anesthesia (2% lignocaine with 1:80,000 adrenaline), the operative field will be isolated with a rubber dam. Standard endodontic access will be prepared, and the working length will be determined using digital radiography.
Instrumentation and Irrigation: Chemo-mechanical preparation will be performed. Irrigation will be carried out using 2 ml of the assigned solution after each instrument. The solution will be delivered using a 27-gauge side-vented needle (Max-i-Probe) kept 1-2 mm short of the working length and maintained in motion to prevent apical extrusion. The flow rate will be controlled at 2-4 ml/min.
Obturation and Follow-up: Canals will be dried with sterile paper points and obturated with gutta-percha and sealer. Participants will be provided with a questionnaire to record their pain after 24 hours using a Visual Analog Scale (VAS). Pain scores will be categorized as no pain (0), mild (1-30), moderate (31-50), or severe (51-100).
Data Analysis:
Data will be analyzed using R software (version 4.3.3). Descriptive statistics (mean, SD, frequencies) will be calculated. Comparative analyses between the two groups will be conducted using the Student's t-test for mean pain scores and the Chi-square test for categorical pain types. Statistical significance will be set at p < 0.05. A key aspect of the analysis plan includes pre-planned subgroup analyses stratified by gender and age to explore their interaction with the irrigant used.
- Conditions
- Postoperative Pain
- Being tested
- Chlorhexidine gluconate 2%, Sodium hypochlorite 5.25%
- Keywords
- Postoperative pain, 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.
Chlorhexidine gluconate 2%Procedure or surgery
2% chlorhexidine gluconate solution used as root canal irrigant. Clear, colorless, odorless liquid. Broad-spectrum antimicrobial with substantivity (binds to dental tissues, prolonged effect up to 72 hours). Does not dissolve organic tissue. Lower cytotoxicity than NaOCl. Applied at 2 mL per instrument, delivered via 27-gauge side-vented Max-i-Probe needle placed 1-2 mm short of working length, passive flow at 2-4 mL/min, continuous needle motion. Room temperature. Final irrigation with same solution
Sodium hypochlorite 5.25%Drug
5.25% sodium hypochlorite solution used as root canal irrigant. Pale yellow liquid with characteristic chlorine odor. Broad-spectrum antimicrobial with rapid bactericidal action. Dissolves organic pulp tissue and necrotic debris. Cytotoxic to periapical tissues if extruded. No substantivity. Applied at 2 mL per instrument, delivered via 27-gauge side-vented Max-i-Probe needle placed 1-2 mm short of working length, passive flow at 2-4 mL/min, continuous needle motion. Room temperature. Final irrigation with same solution.
| Study group | Role | What they receive |
|---|---|---|
| 2% Chlorhexidine Group | Experimental | Root canal irrigation with 2% chlorhexidine gluconate solution. 2 mL after each instrument, 27-gauge side-vented needle, 1-2 mm short of working length, passive flow 2-4 mL/min. Receives: Procedure: Chlorhexidine gluconate 2%; Drug: Sodium hypochlorite 5.25% |
| 5.25% Sodium Hypochlorite Group | Active comparator | Root canal irrigation with 5.25% sodium hypochlorite solution. 2 mL after each instrument, 27-gauge side-vented needle, 1-2 mm short of working length, passive flow 2-4 mL/min. Receives: Procedure: Chlorhexidine gluconate 2%; Drug: Sodium hypochlorite 5.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity at 24 hours
Pain intensity measured using a 4-point Visual Analog Scale (VAS): 0 = no pain, 1 = mild pain, 2 = moderate pain (required analgesics with relief), 3 = severe pain (analgesics no relief). Patient-reported 24 hours post-treatment.
Measured: 24 hours after root canal treatment completion
Postoperative pain intensity at 24 hours
Pain intensity measured using a 4-point Visual Analog Scale (VAS): 0 = no pain, 1 = mild pain, 2 = moderate pain (required analgesics with relief), 3 = severe pain (analgesics no relief). Patient-reported 24 hours post-treatmen
Measured: 24 hours after root canal treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Outcomes assessor
- Enrolment
- 90 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
- NCT07453160
- Sponsor's protocol ID
- SCOD-endo-2025-01
- Acronym
- CHXvsNaOCl-Pai
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain Using 2% Chlorhexidine Versus 5.25% Sodium Hypochlorite as Root Canal Irrigants in Non-surgical Root Canal Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07453160
- Acronym / sponsor ID
- CHXvsNaOCl-Pai / SCOD-endo-2025-01
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Root canal treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 5 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.
Brief Summary (A short description for the lay public)
This study aims to find out if the type of cleaning solution used during a root canal affects the pain a patient feels the next day. A root canal procedure involves cleaning the inside of the tooth. Two common cleaning solutions are chlorhexidine (CHX) and sodium hypochlorite (NaOCl, also known as bleach). While both are effective, it is not clear if one causes more discomfort than the other.
In this research, half of the participants will have their root canal cleaned with CHX, and the other half with NaOCl. We will then ask all participants to rate their pain 24 hours after the procedure using a simple pain scale. Our goal is to see if there is a difference in pain levels between the two groups. The results will help dentists choose the best solution to make their patients more comfortable after treatment
Detailed description
Detailed Description (Extended technical description of the protocol)
This study is designed as a randomized controlled trial to compare the intensity of postoperative pain 24 hours after non-surgical root canal treatment using two different irrigating solutions: 2% chlorhexidine (CHX) and 5.25% sodium hypochlorite (NaOCl). The central hypothesis is that the type of irrigant influences early postoperative pain, but that this effect may be modified by patient-specific factors such as gender and age.
Methodology:
Following ethical approval and informed consent, 90 adult patients indicated for non-surgical root canal treatment will be enrolled using a non-probability consecutive sampling technique. Participants will be randomly allocated to one of two parallel groups (n=45 per group): Group A (2% CHX) and Group B (5.25% NaOCl). The sample size was calculated a priori using the pwr package in R, assuming a 95% confidence level, 80% power, and a moderate effect size based on previous studies.
A standardized endodontic protocol will be followed for all participants to ensure consistency and minimize bias:
Procedure: After administering local anesthesia (2% lignocaine with 1:80,000 adrenaline), the operative field will be isolated with a rubber dam. Standard endodontic access will be prepared, and the working length will be determined using digital radiography.
Instrumentation and Irrigation: Chemo-mechanical preparation will be performed. Irrigation will be carried out using 2 ml of the assigned solution after each instrument. The solution will be delivered using a 27-gauge side-vented needle (Max-i-Probe) kept 1-2 mm short of the working length and maintained in motion to prevent apical extrusion. The flow rate will be controlled at 2-4 ml/min.
Obturation and Follow-up: Canals will be dried with sterile paper points and obturated with gutta-percha and sealer. Participants will be provided with a questionnaire to record their pain after 24 hours using a Visual Analog Scale (VAS). Pain scores will be categorized as no pain (0), mild (1-30), moderate (31-50), or severe (51-100).
Data Analysis:
Data will be analyzed using R software (version 4.3.3). Descriptive statistics (mean, SD, frequencies) will be calculated. Comparative analyses between the two groups will be conducted using the Student's t-test for mean pain scores and the Chi-square test for categorical pain types. Statistical significance will be set at p < 0.05. A key aspect of the analysis plan includes pre-planned subgroup analyses stratified by gender and age to explore their interaction with the irrigant used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% Chlorhexidine Group | Experimental | Procedure: Chlorhexidine gluconate 2%, Drug: Sodium hypochlorite 5.25%Root canal irrigation with 2% chlorhexidine gluconate solution. 2 mL after each instrument, 27-gauge side-vented needle, 1-2 mm short of working length, passive flow 2-4 mL/min. |
| 5.25% Sodium Hypochlorite Group | Active comparator | Procedure: Chlorhexidine gluconate 2%, Drug: Sodium hypochlorite 5.25%Root canal irrigation with 5.25% sodium hypochlorite solution. 2 mL after each instrument, 27-gauge side-vented needle, 1-2 mm short of working length, passive flow 2-4 mL/min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults aged 18-65 years
- Any gender
- Requiring non-surgical root canal treatment
- Willing to provide written informed consent
- Able to report postoperative pain using a validated pain assessment scale -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Chlorhexidine gluconate 2%2% chlorhexidine gluconate solution used as root canal irrigant. Clear, colorless, odorless liquid. Broad-spectrum antimicrobial with substantivity (binds to dental tissues, prolonged effect up to 72 hours). Does not dissolve organic tissue. Lower cytotoxicity than NaOCl. Applied at 2 mL per instrument, delivered via 27-gauge side-vented Max-i-Probe needle placed 1-2 mm short of working length, passive flow at 2-4 mL/min, continuous needle motion. Room temperature. Final irrigation with same solution | Procedure or surgery | 2% Chlorhexidine Group, 5.25% Sodium Hypochlorite Group |
| Sodium hypochlorite 5.25%5.25% sodium hypochlorite solution used as root canal irrigant. Pale yellow liquid with characteristic chlorine odor. Broad-spectrum antimicrobial with rapid bactericidal action. Dissolves organic pulp tissue and necrotic debris. Cytotoxic to periapical tissues if extruded. No substantivity. Applied at 2 mL per instrument, delivered via 27-gauge side-vented Max-i-Probe needle placed 1-2 mm short of working length, passive flow at 2-4 mL/min, continuous needle motion. Room temperature. Final irrigation with same solution. | Drug | 2% Chlorhexidine Group, 5.25% Sodium Hypochlorite Group |
Primary outcome
Postoperative pain intensity at 24 hours
Time frame: 24 hours after root canal treatment completion
Pain intensity measured using a 4-point Visual Analog Scale (VAS): 0 = no pain, 1 = mild pain, 2 = moderate pain (required analgesics with relief), 3 = severe pain (analgesics no relief). Patient-reported 24 hours post-treatment.
Postoperative pain intensity at 24 hours
Time frame: 24 hours after root canal treatment completion
Pain intensity measured using a 4-point Visual Analog Scale (VAS): 0 = no pain, 1 = mild pain, 2 = moderate pain (required analgesics with relief), 3 = severe pain (analgesics no relief). Patient-reported 24 hours post-treatmen
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 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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 Chlorhexidine gluconate 2% and Sodium hypochlorite 5.25% in people with Postoperative Pain, 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 13 inclusion and 0 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 5 Mar 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 Faiz Rahman, BDS (+923451505838, faizr3702@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity at 24 hours (time frame: 24 hours after root canal treatment completion). 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 5 Mar 2026.