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Postoperative PainNCT07901127

Clinical Efficacy of a Natural Biopolymer-Based Irrigant

A study testing Chitosan Nanoparticles in people with Postoperative Pain, run by Minia University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Postoperative Pain
What is being tested?
Chitosan Nanoparticles
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteEgypt
Study dates
5 Jan 2026to 5 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eman Hassan Rady Mohamed, B.D.S contact

+201116269788

emanhassanrady95@gmail.com

Egypt1 site, 1 recruiting
  • Endodontics Department Faculty of Dentistry

    Minya

    Dalia Ali Ahmed Moukarab, Professor, +201068121523, dalia.mokarab@mu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Clinical Efficacy of a Natural Biopolymer-Based Irrigant Under Apical Negative Pressure on Postoperative Sequelae: A Randomized Controlled Clinical Trial

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

Being tested
Chitosan Nanoparticles
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chitosan NanoparticlesProcedure or surgery

    Also called Sodium Hypochlorite

    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.

Study groups in NCT07901127
Study groupRoleWhat they receive
Chitosan with side vent needleActive comparatorAbout 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.
Receives: Procedure: Chitosan Nanoparticles
Chitosan with Apical negative pressure deviceActive comparatorAbout 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.
Receives: Procedure: Chitosan Nanoparticles
Sodium Hypochlorite with side vent needleActive comparatorAbout 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.
Receives: Procedure: Chitosan Nanoparticles
Sodium Hypochlorite with Apical negative pressure deviceActive comparatorAbout 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.
Receives: Procedure: Chitosan Nanoparticles

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study start5 Jan 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion5 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07901127
Sponsor's protocol ID
Biopolymer-Based Irrigant
Status last verified
Jan 2026
First submitted
22 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Chitosan Nanoparticles in people with Postoperative Pain, run by Minia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eman Hassan Rady Mohamed, B.D.S (+201116269788, emanhassanrady95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post Operative Pain (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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