Vital Pulp TherapiesNaOCl PulpotomNCT07774130
Comparison of Sodium Hypochlorite Gel and Solution With and Without Nanoparticles for Postoperative Pain After Pulpotomy in Permanent Mandibular Molars
A study testing Sodium Hypochlorite gel 2%, Sodium hypochlorite gel 2% with chitosan nano particles and Sodium hypochlorite solution 2% with chitosan nanoparticles in people with Vital Pulp Therapies and Pulpotomy, run by Future University in Egypt at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to compare the effect of 2% sodium hypochlorite gel and solution, with and without chitosan nanoparticles, on postoperative pain following pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Therapies, Pulpotomy, Irriversible Pulpitis
- What is being tested?
- Sodium Hypochlorite gel 2%, Sodium hypochlorite gel 2% with chitosan nano particles and Sodium hypochlorite solution 2% with chitosan nanoparticles
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Mar 2027
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars.
- Patients of either gender aged from 15-40.
- Patients free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
- Patients with mature root.
- Patients with no internal or external resorption and no periapical lesions.
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- Tooth give positive response to sensitivity test.
- Tooth is restorable and free from advanced periodontal disease, cracks and splits.
- Hemostasis achieved after total pulpotomy.
- Soft tissues around the tooth are normal with no swelling or sinus tract.
Who cannot join
- • Hemostasis after 10 minutes can not be controlled after total pulpotomy.
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with periapical lesions or infections.
- Pregnant females.
- Patients who could/would not participate in a 6 months follow-up.
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- Patients with fistula or swelling
- Patients with necrotic pulp.
- Patients with old age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Sodium Hypochlorite Gel and Solution, With and Without Nano-particles, on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth; "Randomized Clinical Trail"
This randomized clinical trial aims to compare the effect of 2% sodium hypochlorite gel and solution, with and without chitosan nanoparticles, on postoperative pain following pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis. Participants will be randomly allocated into four parallel groups receiving either 2% sodium hypochlorite solution, 2% sodium hypochlorite gel, 2% sodium hypochlorite solution containing chitosan nanoparticles, or 2% sodium hypochlorite gel containing chitosan nanoparticles as the haemostatic agent during pulpotomy. Postoperative pain will be assessed using an 11-point Numerical Rating Scale at 6, 12, 24, and 72 hours and 7 days after treatment. The study will also evaluate the overall clinical and radiographic success of pulpotomy during follow-up.
- Being tested
- Sodium Hypochlorite gel 2%, Sodium hypochlorite gel 2% with chitosan nano particles, Sodium hypochlorite solution 2% with chitosan nanoparticles, Sodium hypochlorite solution 2%
- Keywords
- sodium hypochlorite gel, sodium hypochlorite solution, chitosan nanoparticles, first mandibular molar, pulpotomy
- 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 gel 2%Procedure or surgery
The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2).
The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant. Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp.
Hemostasis will be achieved by a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into;
- Group A which will be the intervention group and hemostasis is NaOCL gel 2%.
Sodium hypochlorite gel 2% with chitosan nano particlesProcedure or surgery
The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2).
The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant. Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp.
Hemostasis will be achieved by a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into;
- Group B which will be the intervention group and hemostasis is NaOCL gel 2% with chotosan nanoparticles
Sodium hypochlorite solution 2% with chitosan nanoparticlesProcedure or surgery
The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2).
The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant. Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp.
Hemostasis will be achieved by a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into;
- Group C which will be the intervention group and hemostasis is NaOCL solution 2% with chitosan nanoparticles
Sodium hypochlorite solution 2%Procedure or surgery
The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2).
The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant. Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp.
Hemostasis will be achieved by a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into;
- Group D which will be the intervention group and hemostasis is NaOCL solut 2%.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | vital pulp therapy with NaOCL gel 2%. Receives: Procedure: Sodium Hypochlorite gel 2% |
| Intervention 2 | Experimental | vital pulp therapy with NaOCL solution 2% incorporated with nano-particles Receives: Procedure: Sodium hypochlorite gel 2% with chitosan nano particles |
| Intervention 3 | Experimental | vital pulp therapy with NaOCL gel 2% incorporated with nano-particles. Receives: Procedure: Sodium hypochlorite solution 2% with chitosan nanoparticles |
| Control | Experimental | Vital pulp therapy with NaOCL solution 2% . Receives: Procedure: Sodium hypochlorite solution 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
- Postoperative pain reported by the patient after pulpotomy in both groups is to be recorded by NRS (Numerical Rate Scale). Scale from 0-10 recorded every 24hours until the seventh day. The NRS for pain is a straight line with one end (point 0) meaning no pain and the other end (point 10) meaning the worst pain imaginable.
Measured: Pain will be recorded preoperative and after 6hours, 12hours, 24hours, 72hours and one week using numerical rate scale (NRS).
Secondary outcomes (1)
Clinical and Radiographic Overall success
Overall treatment success will be assessed clinically and radiographically at 3, 6, and 12 months after treatment. A participant will be considered successful only if both clinical and radiographic success criteria are met. Clinical success will be defined as the absence of spontaneous pain, swelling, sinus tract, tenderness, abnormal mobility, or abnormal periodontal probing depth. Radiographic success will be defined as the absence of new or increased periapical radiolucency. Failure of either the clinical or radiographic criteria will be considered treatment failure.
Measured: 3, 6, 12, months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Mar 2026
- Primary completion1 Apr 2026
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Pulp TherapiesStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuroq Saeed Ali Farahat, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774130
- Sponsor's protocol ID
- Fue.rec (7)/1-2026
- Acronym
- NaOCl Pulpotom
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Sodium Hypochlorite Gel and Solution, With and Without Nano-particles, on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth; "Randomized Clinical Trail"
- ClinicalTrials.gov ID
- NCT07774130
- Acronym / sponsor ID
- NaOCl Pulpotom / Fue.rec (7)/1-2026
- Keywords
- sodium hypochlorite gel, sodium hypochlorite solution, chitosan nanoparticles, first mandibular molar, pulpotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 Aug 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 clinical trial aims to compare the effect of 2% sodium hypochlorite gel and solution, with and without chitosan nanoparticles, on postoperative pain following pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis. Participants will be randomly allocated into four parallel groups receiving either 2% sodium hypochlorite solution, 2% sodium hypochlorite gel, 2% sodium hypochlorite solution containing chitosan nanoparticles, or 2% sodium hypochlorite gel containing chitosan nanoparticles as the haemostatic agent during pulpotomy. Postoperative pain will be assessed using an 11-point Numerical Rating Scale at 6, 12, 24, and 72 hours and 7 days after treatment. The study will also evaluate the overall clinical and radiographic success of pulpotomy during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Procedure: Sodium Hypochlorite gel 2%vital pulp therapy with NaOCL gel 2%. |
| Intervention 2 | Experimental | Procedure: Sodium hypochlorite gel 2% with chitosan nano particlesvital pulp therapy with NaOCL solution 2% incorporated with nano-particles |
| Intervention 3 | Experimental | Procedure: Sodium hypochlorite solution 2% with chitosan nanoparticlesvital pulp therapy with NaOCL gel 2% incorporated with nano-particles. |
| Control | Experimental | Procedure: Sodium hypochlorite solution 2%Vital pulp therapy with NaOCL solution 2% . |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- • Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars.
Key exclusion criteria (9 listed)
- • Hemostasis after 10 minutes can not be controlled after total pulpotomy.
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 gel 2%The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2). The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant. Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp. Hemostasis will be achieved by a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into; • Group A which will be the intervention group and hemostasis is NaOCL gel 2%. | Procedure or surgery | Intervention 1 |
| Sodium hypochlorite gel 2% with chitosan nano particlesThe procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2). The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant. Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp. Hemostasis will be achieved by a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into; • Group B which will be the intervention group and hemostasis is NaOCL gel 2% with chotosan nanoparticles | Procedure or surgery | Intervention 2 |
| Sodium hypochlorite solution 2% with chitosan nanoparticlesThe procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2). The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant. Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp. Hemostasis will be achieved by a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into; • Group C which will be the intervention group and hemostasis is NaOCL solution 2% with chitosan nanoparticles | Procedure or surgery | Intervention 3 |
| Sodium hypochlorite solution 2%The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2). The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant. Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp. Hemostasis will be achieved by a small cotton pellet socked with agent, the teeth will be then divided into 4 groups depending on the pulpotomy agents into; • Group D which will be the intervention group and hemostasis is NaOCL solut 2%. | Procedure or surgery | Control |
Primary outcome
Post-operative pain
Time frame: Pain will be recorded preoperative and after 6hours, 12hours, 24hours, 72hours and one week using numerical rate scale (NRS).
• Postoperative pain reported by the patient after pulpotomy in both groups is to be recorded by NRS (Numerical Rate Scale). Scale from 0-10 recorded every 24hours until the seventh day. The NRS for pain is a straight line with one end (point 0) meaning no pain and the other end (point 10) meaning the worst pain imaginable.
1 secondary outcome
Clinical and Radiographic Overall success
Time frame: 3, 6, 12, months
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 19 Aug 2026.
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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 gel 2%, Sodium hypochlorite gel 2% with chitosan nano particles and Sodium hypochlorite solution 2% with chitosan nanoparticles in people with Vital Pulp Therapies and Pulpotomy, run by Future University in Egypt at 1 site 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 10 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 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 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?
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?
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: Pain will be recorded preoperative and after 6hours, 12hours, 24hours, 72hours and one week using numerical rate scale (NRS).). 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 19 Aug 2026.