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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Endodontics Department Faculty of Dentistry
Minya
Dalia Ali Ahmed Moukarab, Professor, +201068121523, dalia.mokarab@mu.edu.eg
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
- Conditions
- Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| Chitosan with side vent needle | Active comparator | 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. Receives: Procedure: Chitosan Nanoparticles |
| Chitosan with Apical negative pressure device | Active comparator | 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. Receives: Procedure: Chitosan Nanoparticles |
| Sodium Hypochlorite with side vent needle | Active comparator | 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. Receives: Procedure: Chitosan Nanoparticles |
| Sodium Hypochlorite with Apical negative pressure device | Active comparator | 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. Receives: Procedure: Chitosan Nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted28 Oct 2026
- Study start5 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hassan, Minia University
- Investigators
- Omar Moustafa Ali Fahim, M.D, Study chair, Professor and Head of Department of Endodontics,Faculty of Dentistry,Deraya University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of a Natural Biopolymer-Based Irrigant Under Apical Negative Pressure on Postoperative Sequelae: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07901127
- Acronym / sponsor ID
- Biopolymer-Based Irrigant
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chitosan with side vent needle | Active comparator | Procedure: Chitosan NanoparticlesAbout 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. |
| Chitosan with Apical negative pressure device | Active comparator | Procedure: Chitosan NanoparticlesAbout 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. |
| Sodium Hypochlorite with side vent needle | Active comparator | Procedure: Chitosan NanoparticlesAbout 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. |
| Sodium Hypochlorite with Apical negative pressure device | Active comparator | Procedure: Chitosan NanoparticlesAbout 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitosan NanoparticlesAlso: Sodium HypochloriteTo 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. | Procedure or surgery | Chitosan with Apical negative pressure device, Chitosan with side vent needle, Sodium Hypochlorite with Apical negative pressure device, Sodium Hypochlorite with side vent needle |
Primary outcome
Post Operative Pain
Time frame: 7 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar Moustafa Ali Fahim, M.D study chair
Professor and Head of Department of Endodontics,Faculty of Dentistry,Deraya University
1 site in 1 country: see every site and its status.
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.