Natural Biopolymer-Based Irrigant for Root Canal Cleaning
Official title: Clinical Efficacy of a Natural Biopolymer-Based Irrigant Under Apical Negative Pressure on Postoperative Sequelae: A Randomized Controlled Clinical Trial
Run by Minia University · NCT07901127 · Data updated 2026-11-12
This trial tests a chitosan nanoparticle irrigant to improve cleaning and disinfection in single-rooted teeth with asymptomatic pulp necrosis undergoing endodontic treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya) |
| Status | Recruiting |
| Started | January 5, 2026 |
| Main results expected | January 1, 2027 |
| Study ends | January 5, 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07901127 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with single-rooted teeth and asymptomatic pulp necrosis requiring endodontic treatment, ASA I, and no contraindications to endodontic care.
✕Probably not a fit
Patients with non-eligible tooth anatomy, active infection with complications, or other exclusion criteria may not benefit from this irrigation approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates a natural chitosan nanoparticle irrigant as an alternative to conventional irrigation in root canal therapy. It focuses on improving mechanical debridement and disinfection in single-rooted teeth by leveraging the biocompatible antimicrobial and chelating properties of chitosan nanoparticles. Participants are adults with asymptomatic pulp necrosis and ASA I status, undergoing standard endodontic treatment. The study monitors safety and potential reductions in postoperative pain and microbial load associated with root canal irrigation using the chitosan nanoparticle solution. No outcomes are provided here beyond the description of approach and population.
Why it matters
Potential benefit: If successful, patients may experience improved disinfection of the root canal system with potentially reduced postoperative discomfort.
How similar studies have gone: Previous endodontic research supports the antimicrobial and biocompatible potential of biopolymer-based irrigants, though nanoparticle formulations in this exact context are relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old or older single rooted teeth(oval shaped canals). * Subjects without any relative or absolute contraindication to endodontic treatment as tooth hypermobility (grade III), or presence of untreatable longitudinal fracture. * Clinical diagnosis of asymptomatic pulp necrosis: non-responsive to thermal pulp testing. No pain to percussion or radiographic evidence of osseous breakdown. * Patients who were able to sign an informed consent form. * Subjects classified as ASA-1 following the classification proposed by the American Society of Anesthesiologists. Exclusion Criteria: * Patients taking analgesics or anti-inflammatory drugs in the seven days before intervention * Patients with vital teeth, apical periodontitis, periapical radiolucency, retreatments, root resorption, immature/open apex, or a root canal in which the is no patency to the apical foramen.
Where it's running
-
Endodontics Department Faculty of Dentistry
Minya, Egypt Recruiting
Study contacts
- Study coordinator: Eman Hassan Rady Mohamed, B.D.S
- Email: emanhassanrady95@gmail.com
- Phone: +201116269788
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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.