Symptomatic Irreversible PulpitisNCT07923669
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
A study testing Cryotherapeutic Sodium Hypochlorite Irrigation. and Nanotherapeutic Sodium Hypochlorite Irrigation in people with Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis, run by October 6 University at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to compare the effects of conventional, cryotherapeutic, and nanotherapeutic sodium hypochlorite solutions used as final root canal irrigants on postoperative pain and substance P levels. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
- What is being tested?
- Cryotherapeutic Sodium Hypochlorite Irrigation. and Nanotherapeutic Sodium Hypochlorite Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Apr 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female participants aged 18-50 years.
- Participants willing to complete the entire study period and provide written informed consent after receiving a full explanation of the study.
- Presence of a mandibular single-rooted premolar tooth with vital pulp.
- Patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis, presenting with intermittent or continuous sharp pain persisting after removal of the stimulus and severe preoperative pain assessed using the Visual Analog Scale (VAS).
Who cannot join
- Vulnerable populations, including prisoners, pregnant women, and individuals with mental illness, as specified in the protocol.
- Teeth with open apices.
- Teeth previously treated endodontically.
- Presence of sinus tracts.
- Periodontal pockets greater than 3 mm associated with the affected tooth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, October 6 university
Giza
Faculty of dentistry, October 6 university, 0020238355276, Dent@o6u.edu.eg
Khloud Metwally, Master degree candidate
About this study
Official title: The Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite as Final Irrigants on Post-Operative Pain Level in Patients With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis :Randomized Clinical Trial
This randomized clinical trial aims to compare the effects of conventional, cryotherapeutic, and nanotherapeutic sodium hypochlorite solutions used as final root canal irrigants on postoperative pain and substance P levels.
The study will include 45 patients aged 18-50 years with symptomatic irreversible pulpitis and symptomatic apical periodontitis affecting single-rooted mandibular premolars.
Read more
Participants will be randomly assigned to three equal groups (15 patients per group). The first group will receive conventional 2.5% sodium hypochlorite at room temperature, the second group will receive cryotherapeutic 2.5% sodium hypochlorite at 2-5°C, and the third group will receive nanotherapeutic 2.5% sodium hypochlorite as the final irrigant.
Postoperative pain will be assessed using a 0-10 pain scale at 12, 24, and 48 hours. Substance P levels will be measured in periapical fluid samples using an enzyme-linked immunosorbent assay (ELISA).
The study aims to determine whether cryotherapeutic or nanotherapeutic sodium hypochlorite can reduce postoperative pain and substance P levels compared with conventional sodium hypochlorite.
Read the detailed description
This study is designed to evaluate the effects of different sodium hypochlorite final irrigation approaches on postoperative pain and substance P levels in patients undergoing root canal treatment.
The study will compare three irrigation approaches: conventional sodium hypochlorite, cryotherapeutic sodium hypochlorite, and nanotherapeutic sodium hypochlorite incorporating chitosan nanoparticles.
Eligible participants will undergo clinical and radiographic examinations to confirm the diagnosis of symptomatic irreversible pulpitis with symptomatic apical periodontitis. Following eligibility assessment and informed consent, participants will be randomly allocated to one of the three study groups.
Root canal treatment will be performed according to a standardized endodontic protocol. After root canal instrumentation, the assigned final irrigation approach will be applied.
Postoperative pain will be evaluated using a numerical pain rating scale at the predetermined follow-up intervals. Substance P levels will be assessed using periapical fluid samples and analyzed by enzyme-linked immunosorbent assay (ELISA).
The findings will be used to compare the clinical and biological effects of the three final irrigation approaches and investigate the potential relationship between postoperative pain and substance P levels.
- Being tested
- Cryotherapeutic Sodium Hypochlorite Irrigation., Nanotherapeutic Sodium Hypochlorite Irrigation
- Keywords
- Sodium Hypochlorite, Cryotherapy, Chitosan Nanoparticles, Postoperative Pain, Substance P, Root Canal Irrigation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapeutic Sodium Hypochlorite Irrigation.Procedure or surgery
Final root canal irrigation using 20 mL of 2.5% sodium hypochlorite (NaOCl) maintained at 2-5°C, delivered over 5 minutes following mechanical preparation. Irrigation will be performed using a side-vented needle positioned short of the working length to minimize apical extrusion.
Nanotherapeutic Sodium Hypochlorite IrrigationProcedure or surgery
Final root canal irrigation using 20 mL of nanotherapeutic 2.5% sodium hypochlorite (NaOCl), delivered over 5 minutes following mechanical preparation. Irrigation will be performed using a side-vented needle positioned short of the working length to minimize apical extrusion.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Sodium Hypochlorite Group. | Active comparator | Participants allocated to this group will undergo standard root canal treatment. Following completion of mechanical preparation, final irrigation will be performed using 20 mL of conventional 2.5% sodium hypochlorite (NaOCl) at room temperature, delivered over 5 minutes without any cryotherapeutic modification. The irrigant will be administered using a side-vented needle positioned short of the working length to minimize apical extrusion. Receives: Procedure: Cryotherapeutic Sodium Hypochlorite Irrigation.; Procedure: Nanotherapeutic Sodium Hypochlorite Irrigation |
| Cold Sodium Hypochlorite (Cryotherapy) Group. | Experimental | Participants allocated to this group will undergo standard root canal treatment. Following completion of mechanical preparation, final irrigation will be performed using 20 mL of cryotherapeutic sodium hypochlorite (NaOCl) at a concentration of 2.5%, maintained at 2-5°C and delivered over 5 minutes. The irrigant will be administered using a side-vented needle positioned short of the working length to minimize apical extrusion. Receives: Procedure: Cryotherapeutic Sodium Hypochlorite Irrigation. |
| Nanotherapeutic Sodium Hypochlorite Group. | Experimental | Participants allocated to this group will undergo standard root canal treatment. Following completion of mechanical preparation, final irrigation will be performed using 20 mL of nanotherapeutic sodium hypochlorite (NaOCl) at a concentration of 2.5%, delivered over 5 minutes. The irrigant will be administered using a side-vented needle positioned short of the working length to minimize apical extrusion. Receives: Procedure: Nanotherapeutic Sodium Hypochlorite Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity.
Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS). Pain will be recorded before endodontic treatment and at 12, 24, and 48 hours postoperatively. Pain scores will be classified as mild (0-3), moderate (4-6), or severe (7-10).
Measured: Baseline (before treatment), 12, 24, and 48 hours postoperatively.
Secondary outcomes (1)
Substance P Levels in Periapical Fluid.
Substance P levels in periapical fluid will be measured using an enzyme-linked immunosorbent assay (ELISA). Samples will be collected at three time points: S1, after access cavity preparation and pulp extirpation, before mechanical canal preparation; S2, after cleaning and shaping, before final irrigation; and S3, 24 hours after final irrigation, before root canal obturation.
Measured: S1: Before instrumentation; S2: Before final irrigation; S3: 24 hours after final irrigation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Jul 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khloud Metwally Abdullah Halawa, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923669
- Sponsor's protocol ID
- Reco6u-18/2026
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite as Final Irrigants on Post-Operative Pain Level in Patients With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis :Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07923669
- Acronym / sponsor ID
- Reco6u-18/2026
- Keywords
- Sodium Hypochlorite, Cryotherapy, Chitosan Nanoparticles, Postoperative Pain, Substance P, Root Canal Irrigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 6 Nov 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 effects of conventional, cryotherapeutic, and nanotherapeutic sodium hypochlorite solutions used as final root canal irrigants on postoperative pain and substance P levels.
The study will include 45 patients aged 18-50 years with symptomatic irreversible pulpitis and symptomatic apical periodontitis affecting single-rooted mandibular premolars.
Participants will be randomly assigned to three equal groups (15 patients per group). The first group will receive conventional 2.5% sodium hypochlorite at room temperature, the second group will receive cryotherapeutic 2.5% sodium hypochlorite at 2-5°C, and the third group will receive nanotherapeutic 2.5% sodium hypochlorite as the final irrigant.
Postoperative pain will be assessed using a 0-10 pain scale at 12, 24, and 48 hours. Substance P levels will be measured in periapical fluid samples using an enzyme-linked immunosorbent assay (ELISA).
The study aims to determine whether cryotherapeutic or nanotherapeutic sodium hypochlorite can reduce postoperative pain and substance P levels compared with conventional sodium hypochlorite.
Detailed description
This study is designed to evaluate the effects of different sodium hypochlorite final irrigation approaches on postoperative pain and substance P levels in patients undergoing root canal treatment.
The study will compare three irrigation approaches: conventional sodium hypochlorite, cryotherapeutic sodium hypochlorite, and nanotherapeutic sodium hypochlorite incorporating chitosan nanoparticles.
Eligible participants will undergo clinical and radiographic examinations to confirm the diagnosis of symptomatic irreversible pulpitis with symptomatic apical periodontitis. Following eligibility assessment and informed consent, participants will be randomly allocated to one of the three study groups.
Root canal treatment will be performed according to a standardized endodontic protocol. After root canal instrumentation, the assigned final irrigation approach will be applied.
Postoperative pain will be evaluated using a numerical pain rating scale at the predetermined follow-up intervals. Substance P levels will be assessed using periapical fluid samples and analyzed by enzyme-linked immunosorbent assay (ELISA).
The findings will be used to compare the clinical and biological effects of the three final irrigation approaches and investigate the potential relationship between postoperative pain and substance P levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Sodium Hypochlorite Group. | Active comparator | Procedure: Cryotherapeutic Sodium Hypochlorite Irrigation., Procedure: Nanotherapeutic Sodium Hypochlorite IrrigationParticipants allocated to this group will undergo standard root canal treatment. Following completion of mechanical preparation, final irrigation will be performed using 20 mL of conventional 2.5% sodium hypochlorite (NaOCl) at room temperature, delivered over 5 minutes without any cryotherapeutic modification. The irrigant will be administered using a side-vented needle positioned short of the working length to minimize apical extrusion. |
| Cold Sodium Hypochlorite (Cryotherapy) Group. | Experimental | Procedure: Cryotherapeutic Sodium Hypochlorite Irrigation.Participants allocated to this group will undergo standard root canal treatment. Following completion of mechanical preparation, final irrigation will be performed using 20 mL of cryotherapeutic sodium hypochlorite (NaOCl) at a concentration of 2.5%, maintained at 2-5°C and delivered over 5 minutes. The irrigant will be administered using a side-vented needle positioned short of the working length to minimize apical extrusion. |
| Nanotherapeutic Sodium Hypochlorite Group. | Experimental | Procedure: Nanotherapeutic Sodium Hypochlorite IrrigationParticipants allocated to this group will undergo standard root canal treatment. Following completion of mechanical preparation, final irrigation will be performed using 20 mL of nanotherapeutic sodium hypochlorite (NaOCl) at a concentration of 2.5%, delivered over 5 minutes. The irrigant will be administered using a side-vented needle positioned short of the working length to minimize apical extrusion. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female participants aged 18-50 years.
- Participants willing to complete the entire study period and provide written informed consent after receiving a full explanation of the study.
- Presence of a mandibular single-rooted premolar tooth with vital pulp.
- Patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis, presenting with intermittent or continuous sharp pain persisting after removal of the stimulus and severe preoperative pain assessed using the Visual Analog Scale (VAS).
Key exclusion criteria (5 listed)
- Vulnerable populations, including prisoners, pregnant women, and individuals with mental illness, as specified in the protocol.
- Teeth with open apices.
- Teeth previously treated endodontically.
- Presence of sinus tracts.
- Periodontal pockets greater than 3 mm associated with the affected tooth.
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 |
|---|---|---|
| Cryotherapeutic Sodium Hypochlorite Irrigation.Final root canal irrigation using 20 mL of 2.5% sodium hypochlorite (NaOCl) maintained at 2-5°C, delivered over 5 minutes following mechanical preparation. Irrigation will be performed using a side-vented needle positioned short of the working length to minimize apical extrusion. | Procedure or surgery | Cold Sodium Hypochlorite (Cryotherapy) Group., Conventional Sodium Hypochlorite Group. |
| Nanotherapeutic Sodium Hypochlorite IrrigationFinal root canal irrigation using 20 mL of nanotherapeutic 2.5% sodium hypochlorite (NaOCl), delivered over 5 minutes following mechanical preparation. Irrigation will be performed using a side-vented needle positioned short of the working length to minimize apical extrusion. | Procedure or surgery | Conventional Sodium Hypochlorite Group., Nanotherapeutic Sodium Hypochlorite Group. |
Primary outcome
Postoperative Pain Intensity.
Time frame: Baseline (before treatment), 12, 24, and 48 hours postoperatively.
Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS). Pain will be recorded before endodontic treatment and at 12, 24, and 48 hours postoperatively. Pain scores will be classified as mild (0-3), moderate (4-6), or severe (7-10).
1 secondary outcome
Substance P Levels in Periapical Fluid.
Time frame: S1: Before instrumentation; S2: Before final irrigation; S3: 24 hours after final irrigation.
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 6 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapeutic Sodium Hypochlorite Irrigation. and Nanotherapeutic Sodium Hypochlorite Irrigation in people with Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis, run by October 6 University 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Nov 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity. (time frame: Baseline (before treatment), 12, 24, and 48 hours postoperatively.). 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 6 Nov 2026.