Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite for Post-Operative Endodontic Pain
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
Run by October 6 University · NCT07923669 · Data updated 2026-11-12
This trial tests whether cooling or nano-enhanced sodium hypochlorite as the final root canal irrigant can reduce pain after treatment in adults with certain tooth infections.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | October 6 University Academic / other |
| Locations | 1 site (Giza) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07923669 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–50 with symptomatic irreversible pulpitis and symptomatic apical periodontitis affecting a single-rooted mandibular premolar.
✕Probably not a fit
Patients not experiencing reduced pain or who do not respond biologically to the irrigation approach may see no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized study, 45 adults with symptomatic irreversible pulpitis and symptomatic apical periodontitis affecting single-rooted mandibular premolars are assigned to three final irrigation methods: conventional room-temperature sodium hypochlorite, cryotheraputic sodium hypochlorite at 2–5°C, and nanotherapeutic sodium hypochlorite with chitosan nanoparticles. Postoperative pain is measured on a 0–10 scale at 12, 24, and 48 hours, and substance P levels are quantified in periapical fluid by ELISA to explore biological correlates of pain. The trial uses a standardized endodontic protocol across groups and compares clinical and biochemical outcomes to see if temperature or nanotechnology modulates pain.
Why it matters
Potential benefit: If successful, patients may experience less postoperative pain and better pain management after root canal treatment.
How similar studies have gone: Previous approaches altering irrigation temperature or adding nanoparticles have shown mixed results; this study adds randomized, controlled data in a specific clinical setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where it's running
-
Faculty of dentistry, October 6 university
Giza, Egypt Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.