An interventional study of Cryotherapeutic Sodium Hypochlorite Irrigation. and Nanotherapeutic Sodium Hypochlorite Irrigation in Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis, sponsored by October 6 University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by October 6 University · Not applicable, Interventional, and Treatment
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 45 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →October 6 University is the lead sponsor of 148 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Cryotherapeutic Sodium Hypochlorite Irrigation. · Procedure: Nanotherapeutic 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.
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 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.
Procedure: Nanotherapeutic 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.
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.
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).
Time frame: Baseline (before treatment), 12, 24, and 48 hours postoperatively.
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.
Time frame: S1: Before instrumentation; S2: Before final irrigation; S3: 24 hours after final irrigation.
Started Jul 2026 (actual). Primary completion is estimated for Apr 2027, 9 months after the start.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 9 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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