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RecruitingNCT07901127Updated Oct 28, 2026

Clinical Efficacy of a Natural Biopolymer-Based Irrigant

An interventional study of Chitosan Nanoparticles in Postoperative Pain, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2026, registered Oct 2026).
  • Started Jan 2026; still recruiting 10 months later.
Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

One primary objective in the root canal treatments is to ensure chemo mechanical removal of microorganisms and organic/inorganic tissue residues from the infected root canals. Studies in the literature report that due to the structure of the root canals, mechanical instrumentation alone could not perform a satisfying cleaning in the canal. some areas have remained unreached and infected, thus irrigation has played a key role in the achievement of root canal treatments.

Read the detailed description

Irrigation is a process performed to make the mechanical preparation easier through lubrication by wetting the root canals with liquids of different types and concentrations, and to ensure the disinfection of the root canals by removing the organic/inorganic debris, infected pulp tissue, microorganisms, soft and hard tissue residues from the root canals both physically and chemically.

For many years, sodium hypochlorite at a concentration of 0.5-5.25 percent has been the gold standard and one of the most regularly used irrigation solutions in endodontics. Sodium hypochlorite has various features, such as antibacterial activity due to its proteolytic potential and tissue dissolving ability.

However, NaOCl may be cytotoxic to the periradicular tissues, particularly at high concentrations. AS such, postoperative pain is a concern when highly concentrated NaOCl solutions are used in single-visit treatment of non-vital teeth because of the risk of extravasation of the irrigant into these tissues.

Recently, herbal products gained research interest worldwide because of their medicinal properties including high biocompatibility, anti-microbial, and anti-inflammatory properties favoring their use as root canal irrigants.

Chitosan is a naturally occurring polysaccharide. It is nontoxic, biocompatible, and biodegradable. Its use in the field of endodontics was based on its broad-spectrum antimicrobial activity and considerable chelating effects.

Nanoparticles possess better antimicrobial activity thanks to their polycationic/polyanionic nature together with their high surface area and charge density, providing more interaction with the bacterial cells . Therefore, chitosan nanoparticles (CNPs) have been employed in different health-care domains including root canal therapy.

Chitosan has antimicrobial effects against a broad of gram-positive and gram-negative bacteria. Previous in-vitro studies have demonstrated the significant antibiofilm efficacy of CNPs. It has the ability to interfere with bacterial adhesion thereby hindering the biofilm formation.

The antibacterial mechanism of chitosan has been attributed to its polycationic nature that interacts with the negatively charged surface of bacteria, altering cell permeability and resulting in the leakage of intracellular components. In addition, CNPs are able to inhibit bacterial enzymatic degradation reducing the possibility of bacterial penetration.

Conventional irrigation with syringes has been advocated as an efficient method of irrigant delivery before the advent of passive ultrasonic activation. This technique is still widely accepted by both general practitioners and endodontists. The technique involves dispensing of an irrigant into a canal through needles of variable gauges, either passively or with agitation. The latter is achieved by moving the needle up and down the canal space. Irrigation tip gauge and tip design can have a significant impact on the irrigation flow pattern, flow velocity, depth of penetration, and pressure on the walls and apex of the canal.

Despite its wide use, it appears unable to clean and disinfect areas beyond the main root canal . In addition, it has been linked to a number of irrigant extrusion.

Negative pressure irrigation is an alternative method for the delivery of irrigants inside the root canal that was proposed in order to minimize the risk of irrigant extrusion through the apical foramen and provide better cleanliness and disinfection. Negative pressure irrigation allows potentially large volumes of irrigant to reach the apical region and better debridement of the apical root canal. Irrigants are delivered by a syringe and needle inside the pulp chamber and a fine suction tip placed near working length creates the necessary negative pressure that drives the irrigant into the canal

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 84 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years old or older single rooted teeth(oval shaped canals).
  • Subjects without any relative or absolute 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 form.
  • Subjects classified as ASA-1 following the classification proposed by the .

Exclusion criteria

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.
Terms in these criteria, in plain language(3)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Active comparator
    Chitosan with side vent needle

    About 21 participants will subject to Activation, the activation will be done using side vent needle( Endo-Eze™ Irrigator Tip) activation for 3 cycles each cycle 20 seconds.

    Procedure: Chitosan Nanoparticles

  • Active comparator
    Chitosan with Apical negative pressure device

    About 21 participants will subject to Activation, the activation will be done using apical negative pressure device( SafeClean Device, DENTAL SHOP, Egypt) activation for 3 cycles each cycle 20 seconds.

    Procedure: Chitosan Nanoparticles

  • Active comparator
    Sodium Hypochlorite with side vent needle

    About 21 participants will subject to Activation, the activation will be done using side vent needle( Endo-Eze™ Irrigator Tip) activation for 3 cycles each cycle 20 seconds.

    Procedure: Chitosan Nanoparticles

  • Active comparator
    Sodium Hypochlorite with Apical negative pressure device

    About 21 participants will subject to Activation, the activation will be done using apical negative pressure device( SafeClean Device, DENTAL SHOP, Egypt) activation for 3 cycles each cycle 20 seconds.

    Procedure: Chitosan Nanoparticles

Interventions

  • ProcedureChitosan Nanoparticles

    To evaluate the incidence and intensity of postoperative pain and acute exacerbations following root canal debridement using Apical Negative Pressure-mediated Chitosan nanoparticles versus Sodium Hypochlorite.

    Also known as: Sodium Hypochlorite

06

What researchers measure

Primary outcomes

  1. Post Operative Pain

    Assessment of the participants after the treatment from pain using numerical rating scale (NRS) to record their assessment of pain after (12) hours, then every day up to 7 days.Patients will be instructed to attribute a value to their perceived pain based on the NRS, which is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain.

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

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 ↗

09

Registry details

Key details

Study ID
NCT07901127
Lead sponsor
Minia University
Responsible party
Eman Hassan (Resident at Department of Endodontics, Faculty of Dentistry, Minia University) — Principal investigator
First posted
Oct 28, 2026
Start date
Jan 5, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 5, 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Eman Hassan Rady Mohamed, B.D.S
Contact
emanhassanrady95@gmail.com
+201116269788
Omar Moustafa Ali Fahim, M.D
study chair · Professor and Head of Department of Endodontics,Faculty of Dentistry,Deraya University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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