Clinical trial Recruiting at 1 site Interventional Ages 18 to 50

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.

More Apical Periodontitis trials

Quick facts

Study typeInterventional
Ages18 Years to 50 Years
SexAll
Enrollment45 (estimated)
SponsorOctober 6 University
Academic / other
Locations1 site (Giza)
StatusRecruiting
StartedJuly 1, 2026
Main results expectedApril 1, 2027
Study endsApril 1, 2027
Registry record updatedNovember 6, 2026
Trial IDNCT07923669 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.