Symptomatic Irreversible Pulpitis (SIP)NCT07248189
The Effect of Commercial and Medical Grade Sodium Hypochlorite on Post Endodontic Pain
A study testing commercially available Sodium Hypochlorite and Medical grade Sodium Hypochlorite in people with Symptomatic Irreversible Pulpitis (SIP), run by Cairo University at 2 sites in Egypt.
Trial summary
the aim of the current study is to evaluate the effects of commercial and medical formulations of NaOCl on postoperative pain after endodontic treatment of mandibular posterior teeth with acute irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP)
- What is being tested?
- commercially available Sodium Hypochlorite and Medical grade Sodium Hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2025to 27 Dec 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients with symptomatic irreversible pulpitis. 2. Patients with active pain (moderate-to-severe) in mandibular molars. 4. Males and females. 5. Patient with the ability to understand and use pain scales. 6. Patient who accepts to enroll to the study.
Who cannot join
- 1. Pregnant females. 2. Patients taking pain medication 12 hours earlier. 3. Patient having more than one symptomatic mandibular tooth in the same quadrant.
- 4. Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
- 5. Patients with contributory medical history (ASA>II).
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry, Cairo University
Cairo, 4450113
Faculty of Oral and Dental Medicine, Egyptian Russian University
Cairo, 4450113
About this study
Official title: Postoperative Pain After Single Visit Root Canal Treatment Using Commercial or Medical Grade Sodium Hypochlorite as Irrigating Solutions in Patients With Symptomatic Irreversible Pulpitis in Their Mandibular Molars: A Randomized Controlled Trial
the aim of the current study is to evaluate the effects of commercial and medical formulations of NaOCl on postoperative pain after endodontic treatment of mandibular posterior teeth with acute irreversible pulpitis.
Personal data including name, address, and phone number in addition to medical history and dental history will be collected by the operator from each patient in specific forms, then history of chief complaint will be recorded. The selected patients should show symptoms of irreversible pulpitis. The operator will perform extra-oral and intra-oral clinical examination as the expected tooth to be included in this study should be examined tentatively using a diagnostic mirror and probe. Radiograph will be taken to help to identify if there is widening of periodontal ligament space, periapical radiolucency, deep caries near the pulp chamber or recurrent caries under restoration.
Read more
The diagnosis of symptomatic irreversible pulpitis is confirmed through the patients' history of moderate to severe pain with hot and/or cold in mandibular posterior area, prolonged exaggerated response to cold testing than the contralateral tooth and positive response to electric pulp tester. Radiograph should show no or slight widening of periodontal ligaments. After completing the diagnosis (symptomatic irreversible pulpitis) and confirming that the patient fulfills the eligibility criteria, the patient will be enrolled in the study. The treatment will be done in a single visit.
- Treatment procedure: Each patient will be given an NRS chart to rate her /his presenting pain as preoperative pain. After administering anesthesia, access cavity will be performed using round bur size 4 and Endo-Z bur (DENTSPLY, Tulsa Dental, DENTSPLY Maillefer, TN, USA), then the tooth will be isolated using rubber dam, at this point, patients will be randomly assigned to either of two groups according to the used irrigating solution, group 1, irrigation will be done using the professional form of NaOCl and group 2, irrigation will be done using the commercial form of NaOCl. Irrigant preparation will be done by a dentist who is not involved in the study so that the operator would be blind to the irrigant used. Working length will be determined by the apex locator (Root ZX, J.Morita USA, Irvine, USA) and radiographically confirmed as 0.5-1 mm shorter from the radiographic apex. Root canal treatment will be, then, completed using Edge X7 (Edge-Endo, USA) NiTi rotary files system according to the manufacturer instructions. All canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every two subsequent instruments. Canals will be dried then obturated by the modified single cone technique using 0.04 taper gutta percha points and epoxy resin sealer (ADSEAL, METABIOMED.CO., LTD, Korea) and then a spreader will be used to provide space for auxiliary cones. The access cavity will be then sealed with temporary filling (MD-TEMP, META BIOMED CO., LTD. Chungbuuk, Korea).
Patients will be referred to an operative or a fixed prosthodontics specialist for crown placement at the Faculty of Dentistry, Egyptian Russian University. Post-operative instructions and appropriate post-operative rescue medication will be prescribed (400mg Ibuprofen). All patients will be asked to record their postoperative pain level felt on NRS at 6, 12, 24, 48, 72 hours and 7 days.
Research objective (state the aim) The aim of this study is to assess the effect of different sodium hypochlorite preparations (commercial VS medical) on postoperative pain in patients with symptomatic irreversible pulpitis after single visit endodontic treatment.
Sample size:
Anticipated sample size, 60 patients will be included in the study, divided into 2 groups, 30 patients per group.
Grouping \& Randomization used:(specify if present) Two groups Group 1: Professional NaOCl Group 2: Commercial NaOCl
Outcome variables:
The primary outcome is the effect on Postoperative pain which will be measured using NRS at 6, 12, 24, 48, 72 hours postoperatively. Numerical Rating Scale (NRS) (20): It is an 11-point scale consisting of numbers from 0 through 10; - 0 reading represents "no pain" - 1-3 readings represent "mild pain" - 4- 6 readings represent "moderate pain" - 7- 10 readings represent "severe pain"
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Being tested
- commercially available Sodium Hypochlorite, Medical grade Sodium Hypochlorite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
commercially available Sodium HypochloriteDrug
during the routine root canal treatment of mandibular molars with SIP, irrigation will be performed between each two successive files with 2 ml of half concentration commercially available sodium hypochlorite and after complete preparation 5 ml of the same solution will be used in full concentration for the purpose of smear layer removal.
Medical grade Sodium HypochloriteDrug
during the routine root canal treatment of mandibular molars with SIP, irrigation will be performed between each two successive files with 2 ml of half concentration Medical grade sodium hypochlorite and after complete preparation 5 ml of the same solution will be used in full concentration for the purpose of smear layer removal.
| Study group | Role | What they receive |
|---|---|---|
| Commercial NaOCl | Active comparator | Not described Receives: Drug: commercially available Sodium Hypochlorite |
| Medical Grade NaOCl | Experimental | Not described Receives: Drug: Medical grade Sodium Hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative pain
incidence and intensity of post operative pain after single visit root canal treatment of mandibular molars with SIP
Measured: from enrollemnt to 72 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 posted25 Nov 2025
- Study start1 Oct 2025
- Primary completion1 Dec 2025
- Study completion27 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Nasr, Egyptian Russian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248189
- Sponsor's protocol ID
- ERU3
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Severing AL, Rembe JD, Koester V, Stuermer EK. Safety and efficacy profiles of different commercial sodium hypochlorite/hypochlorous acid solutions (NaClO/HClO): antimicrobial efficacy, cytotoxic impact and physicochemical parameters in vitro. J Antimicrob Chemother. 2019 Feb 1;74(2):365-372. doi: 10.1093/jac/dky432.
PubMed 30388236van der Waal SV, van Dusseldorp NE, de Soet JJ. An evaluation of the accuracy of labeling of percent sodium hypochlorite on various commercial and professional sources: is sodium hypochlorite from these sources equally suitable for endodontic irrigation? J Endod. 2014 Dec;40(12):2049-52. doi: 10.1016/j.joen.2014.08.021. Epub 2014 Oct 7.
PubMed 25301349Mostafa MEHAA, El-Shrief YAI, Anous WIO, Hassan MW, Salamah FTA, El Boghdadi RM, El-Bayoumi MAA, Seyam RM, Abd-El-Kader KG, Amin SAW. Postoperative pain following endodontic irrigation using 1.3% versus 5.25% sodium hypochlorite in mandibular molars with necrotic pulps: a randomized double-blind clinical trial. Int Endod J. 2020 Feb;53(2):154-166. doi: 10.1111/iej.13222. Epub 2019 Oct 23.
PubMed 31563148Siqueira JF Jr, Rocas IN, Favieri A, Machado AG, Gahyva SM, Oliveira JC, Abad EC. Incidence of postoperative pain after intracanal procedures based on an antimicrobial strategy. J Endod. 2002 Jun;28(6):457-60. doi: 10.1097/00004770-200206000-00010.
PubMed 12067129Nasr M, Hassan N. Postoperative pain after single visit root canal treatment using domestic vs. medical grade sodium hypochlorite: a randomized controlled trial. BMC Oral Health. 2026 Apr 13;26(1):696. doi: 10.1186/s12903-026-08185-x.
PubMed 41975390
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Single Visit Root Canal Treatment Using Commercial or Medical Grade Sodium Hypochlorite as Irrigating Solutions in Patients With Symptomatic Irreversible Pulpitis in Their Mandibular Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07248189
- Acronym / sponsor ID
- ERU3
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 27 Dec 2025 (actual)
- First posted
- 25 Nov 2025 (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.
the aim of the current study is to evaluate the effects of commercial and medical formulations of NaOCl on postoperative pain after endodontic treatment of mandibular posterior teeth with acute irreversible pulpitis.
Personal data including name, address, and phone number in addition to medical history and dental history will be collected by the operator from each patient in specific forms, then history of chief complaint will be recorded. The selected patients should show symptoms of irreversible pulpitis. The operator will perform extra-oral and intra-oral clinical examination as the expected tooth to be included in this study should be examined tentatively using a diagnostic mirror and probe. Radiograph will be taken to help to identify if there is widening of periodontal ligament space, periapical radiolucency, deep caries near the pulp chamber or recurrent caries under restoration.
The diagnosis of symptomatic irreversible pulpitis is confirmed through the patients' history of moderate to severe pain with hot and/or cold in mandibular posterior area, prolonged exaggerated response to cold testing than the contralateral tooth and positive response to electric pulp tester. Radiograph should show no or slight widening of periodontal ligaments. After completing the diagnosis (symptomatic irreversible pulpitis) and confirming that the patient fulfills the eligibility criteria, the patient will be enrolled in the study. The treatment will be done in a single visit.
- Treatment procedure: Each patient will be given an NRS chart to rate her /his presenting pain as preoperative pain. After administering anesthesia, access cavity will be performed using round bur size 4 and Endo-Z bur (DENTSPLY, Tulsa Dental, DENTSPLY Maillefer, TN, USA), then the tooth will be isolated using rubber dam, at this point, patients will be randomly assigned to either of two groups according to the used irrigating solution, group 1, irrigation will be done using the professional form of NaOCl and group 2, irrigation will be done using the commercial form of NaOCl. Irrigant preparation will be done by a dentist who is not involved in the study so that the operator would be blind to the irrigant used. Working length will be determined by the apex locator (Root ZX, J.Morita USA, Irvine, USA) and radiographically confirmed as 0.5-1 mm shorter from the radiographic apex. Root canal treatment will be, then, completed using Edge X7 (Edge-Endo, USA) NiTi rotary files system according to the manufacturer instructions. All canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every two subsequent instruments. Canals will be dried then obturated by the modified single cone technique using 0.04 taper gutta percha points and epoxy resin sealer (ADSEAL, METABIOMED.CO., LTD, Korea) and then a spreader will be used to provide space for auxiliary cones. The access cavity will be then sealed with temporary filling (MD-TEMP, META BIOMED CO., LTD. Chungbuuk, Korea).
Patients will be referred to an operative or a fixed prosthodontics specialist for crown placement at the Faculty of Dentistry, Egyptian Russian University. Post-operative instructions and appropriate post-operative rescue medication will be prescribed (400mg Ibuprofen). All patients will be asked to record their postoperative pain level felt on NRS at 6, 12, 24, 48, 72 hours and 7 days.
Research objective (state the aim) The aim of this study is to assess the effect of different sodium hypochlorite preparations (commercial VS medical) on postoperative pain in patients with symptomatic irreversible pulpitis after single visit endodontic treatment.
Sample size:
Anticipated sample size, 60 patients will be included in the study, divided into 2 groups, 30 patients per group.
Grouping \& Randomization used:(specify if present) Two groups Group 1: Professional NaOCl Group 2: Commercial NaOCl
Outcome variables:
The primary outcome is the effect on Postoperative pain which will be measured using NRS at 6, 12, 24, 48, 72 hours postoperatively. Numerical Rating Scale (NRS) (20): It is an 11-point scale consisting of numbers from 0 through 10; - 0 reading represents "no pain" - 1-3 readings represent "mild pain" - 4- 6 readings represent "moderate pain" - 7- 10 readings represent "severe pain"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial NaOCl | Active comparator | Drug: commercially available Sodium Hypochlorite |
| Medical Grade NaOCl | Experimental | Drug: Medical grade Sodium Hypochlorite |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Patients with symptomatic irreversible pulpitis. 2. Patients with active pain (moderate-to-severe) in mandibular molars. 4. Males and females. 5. Patient with the ability to understand and use pain scales. 6. Patient who accepts to enroll to the study.
Key exclusion criteria (3 listed)
- 1. Pregnant females. 2. Patients taking pain medication 12 hours earlier. 3. Patient having more than one symptomatic mandibular tooth in the same quadrant.
- 4. Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
- 5. Patients with contributory medical history (ASA>II).
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 |
|---|---|---|
| commercially available Sodium Hypochloriteduring the routine root canal treatment of mandibular molars with SIP, irrigation will be performed between each two successive files with 2 ml of half concentration commercially available sodium hypochlorite and after complete preparation 5 ml of the same solution will be used in full concentration for the purpose of smear layer removal. | Drug | Commercial NaOCl |
| Medical grade Sodium Hypochloriteduring the routine root canal treatment of mandibular molars with SIP, irrigation will be performed between each two successive files with 2 ml of half concentration Medical grade sodium hypochlorite and after complete preparation 5 ml of the same solution will be used in full concentration for the purpose of smear layer removal. | Drug | Medical Grade NaOCl |
Primary outcome
Post Operative pain
Time frame: from enrollemnt to 72 hours after treatment
incidence and intensity of post operative pain after single visit root canal treatment of mandibular molars with SIP
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 2 Jan 2026.
- Background: PubMed 30388236Severing AL, Rembe JD, Koester V, Stuermer EK. Safety and efficacy profiles of different commercial sodium hypochlorite/hypochlorous acid solutions (NaClO/HClO): antimicrobial efficacy, cytotoxic impact and physicochemical parameters in vitro. J Antimicrob Chemother. 2019 Feb 1;74(2):365-372. doi: 10.1093/jac/dky432.
- Background: PubMed 25301349van der Waal SV, van Dusseldorp NE, de Soet JJ. An evaluation of the accuracy of labeling of percent sodium hypochlorite on various commercial and professional sources: is sodium hypochlorite from these sources equally suitable for endodontic irrigation? J Endod. 2014 Dec;40(12):2049-52. doi: 10.1016/j.joen.2014.08.021. Epub 2014 Oct 7.
- Background: PubMed 31563148Mostafa MEHAA, El-Shrief YAI, Anous WIO, Hassan MW, Salamah FTA, El Boghdadi RM, El-Bayoumi MAA, Seyam RM, Abd-El-Kader KG, Amin SAW. Postoperative pain following endodontic irrigation using 1.3% versus 5.25% sodium hypochlorite in mandibular molars with necrotic pulps: a randomized double-blind clinical trial. Int Endod J. 2020 Feb;53(2):154-166. doi: 10.1111/iej.13222. Epub 2019 Oct 23.
- Background: PubMed 12067129Siqueira JF Jr, Rocas IN, Favieri A, Machado AG, Gahyva SM, Oliveira JC, Abad EC. Incidence of postoperative pain after intracanal procedures based on an antimicrobial strategy. J Endod. 2002 Jun;28(6):457-60. doi: 10.1097/00004770-200206000-00010.
- Derived from this study: PubMed 41975390Nasr M, Hassan N. Postoperative pain after single visit root canal treatment using domestic vs. medical grade sodium hypochlorite: a randomized controlled trial. BMC Oral Health. 2026 Apr 13;26(1):696. doi: 10.1186/s12903-026-08185-x.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing commercially available Sodium Hypochlorite and Medical grade Sodium Hypochlorite in people with Symptomatic Irreversible Pulpitis (SIP), run by Cairo University at 2 sites in Egypt.
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 3 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 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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: from enrollemnt to 72 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07248189, which also lists 5 linked publications.
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 2 Jan 2026.