Post Operative PainNCT07800403
Efficacy of a Novel Nanoparticle -Augmented Disinfection Protocol
A study testing Novel Nanoparticle in people with Post Operative Pain, run by Minia University at 1 site in Egypt.
Trial summary
The ultimate biological aim of endodontic therapy is to either prevent or heal apical periodontitis. Root canal treatment can fail for various reasons, such as persistent infection, missing canals, ledges, canal transportation, instrument separation, and perforation. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Novel Nanoparticle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jul 2026to 14 Jul 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
- Diabetic patients type II of either gender aged from 18-40 years
- Permanent mature Maxillary anterior teeth having a baseline periapical lesion (PAI score ≥3).
Who cannot join
- Immuno-compromised patients.
- Pregnant women and smokers.
- Patients with a history of antibiotic or analgesics intake within the few days before the endodontic treatment.
- Teeth with root fractures or perforations.
- Teeth with lesions connected to adjacent teeth.
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
Minia University, Faculty of Dentistry
Minya
Ahmed Ali Yossef, Lecturer, +201007335293, ahmed.yousef@mu.edu.eg
About this study
Official title: Efficacy of a Novel Nanoparticle -Augmented Disinfection Protocol in the Non -Surgical Retreatment of Maxillary Anterior Teeth in Type II Diabetic Patients: A Randomized Clinical Trial
The ultimate biological aim of endodontic therapy is to either prevent or heal apical periodontitis. Root canal treatment can fail for various reasons, such as persistent infection, missing canals, ledges, canal transportation, instrument separation, and perforation.
Post-treatment apical periodontitis is an inflammatory response in the tissues surrounding the root tip, triggered by either lingering bacteria from the initial procedure or a new, secondary infection within the canal system. Statistically, this condition affects roughly 5% to 20% of cases where apical periodontitis was present before the initial treatment.
Read the detailed description
The primary objective of endodontic therapy is rigorous infection control, achieved through the chemo-mechanical preparation of the root canal system. While mechanical filing shapes the canal, it is physically impossible for instruments to reach every internal surface.5 Consequently, chemical irrigation is the only method available to disinfect "untouched" anatomical complexities-such as isthmuses, fins, and large lateral canals. These hidden areas often harbor tissue debris and resilient biofilms that must be dissolved or neutralized chemically to ensure long-term clinical success.
While traditional irrigants like Sodium Hypochlorite (NaOCl) and EDTA remain the clinical gold standards, the field is shifting toward natural alternatives. Chitosan and Aloe Vera have recently emerged as effective herbal options, with Chitosan gaining particular attention as a promising final irrigation solution. Derived from natural sources, Chitosan is highly accessible and cost-effective. It offers a unique combination of biological and chemical benefits that address the limitations of traditional synthetic chemicals.
Chitosan, and specifically Chitosan Nanoparticles (CNPs), exhibits potent antimicrobial activity against a wide spectrum of both Gram-positive and Gram-negative bacteria. Research indicates that CNPs are highly effective at disrupting biofilms by preventing bacteria from adhering to the canal surfaces, effectively halting the development of complex microbial communities. The primary antibacterial action of Chitosan is derived from its polycationic (positively charged) nature. This charge creates a fatal attraction to the negatively charged surfaces of bacterial cells, leading to two major destructive effects.
Activation of irrigating solution by techniques as passive ultrasonic irrigation (PUI), enhances its efficacy and dynamic flow, and improves its antibacterial property and clinical outcomes.
Diabetes mellitus (DM) is defined as a multisystem complex metabolic disease that affects around 9% of the adult population. DM has two types, type 2 DM (T2DM) is caused by decreased cellular sensitivity of beta cells in islets of Langerhans of the pancreas to insulin which is referred as "insulin resistance". In general DM has an effect on the immune system that could be seen as a delay in wound healing with increased susceptibility to chronic inflammation and impaired tissue repair10.
Considering dental health, DM was reported to be the third most prevalent chronic medical condition among dental patients. Patients with DM are more liable to the development of several oral infections including fungal and bacterial infections. This is believed to be due to the decrease in salivary flow rate which in return leads to the absence of its antimicrobial effects11. DM patients have reduced beta-endorphin production which translates to higher pain perception in diabetic patients, this reduction in beta-endorphin levels might be responsible for higher pain incidence postoperatively in controlled patients12.
- Conditions
- Post Operative Pain
- Being tested
- Novel Nanoparticle
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel NanoparticleProcedure or surgery
Also called Non -Surgical Retreatment of Maxillary Anterior Teeth
To evaluate efficacy of a Novel Nanoparticle -Augmented Disinfection Protocol in the Non -Surgical Retreatment of Maxillary Anterior Teeth with Periapical Lesions in Type II Diabetic Patients
| Study group | Role | What they receive |
|---|---|---|
| Non- surgical retreatment Novel Nanoparticle (NSRN) | Active comparator | About 14 cases will be irrigated with 5 ml of Novel Nanoparticle -Augmented irrigation placed in the root canal and activated passively with woodpecker ultrasonic (Guilin Woodpecker Medical Instrument Co., Ltd., China) for 3 cycle 20 seconds. Receives: Procedure: Novel Nanoparticle |
| Non -surgical root canal retreatment (NSRC) | Active comparator | About 14 cases will be irrigated with 5 ml of (2.5%) NaOCl placed in the root canal and activated passively with woodpecker ultrasonic scaler (Guilin Woodpecker Medical Instrument Co., Ltd., China) for 3 cycle 20 seconds. Receives: Procedure: Novel Nanoparticle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain
Evaluation of the cases from the pain after the procedures by using point numeric rating scale by another operator at 24, 48 and 72-hours.
Measured: from 24 hours to 72 hours after the procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start14 Jul 2026
- Primary completion7 Jul 2027 (estimated)
- Study completion14 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebthal Hamada Saleh, Minia University
- Investigators
- Dalia Ali Ahmed Moukarab, Professor, Study chair, Professor of Endodontics Head of Endodontic Department,Faculty of Dentistry,Future University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800403
- Sponsor's protocol ID
- Novel Nanoparticle
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2026
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Nanoparticle -Augmented Disinfection Protocol in the Non -Surgical Retreatment of Maxillary Anterior Teeth in Type II Diabetic Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07800403
- Acronym / sponsor ID
- Novel Nanoparticle
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 14 Jul 2027 (estimated)
- First posted
- 2 Sep 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.
The ultimate biological aim of endodontic therapy is to either prevent or heal apical periodontitis. Root canal treatment can fail for various reasons, such as persistent infection, missing canals, ledges, canal transportation, instrument separation, and perforation.
Post-treatment apical periodontitis is an inflammatory response in the tissues surrounding the root tip, triggered by either lingering bacteria from the initial procedure or a new, secondary infection within the canal system. Statistically, this condition affects roughly 5% to 20% of cases where apical periodontitis was present before the initial treatment.
Detailed description
The primary objective of endodontic therapy is rigorous infection control, achieved through the chemo-mechanical preparation of the root canal system. While mechanical filing shapes the canal, it is physically impossible for instruments to reach every internal surface.5 Consequently, chemical irrigation is the only method available to disinfect "untouched" anatomical complexities-such as isthmuses, fins, and large lateral canals. These hidden areas often harbor tissue debris and resilient biofilms that must be dissolved or neutralized chemically to ensure long-term clinical success.
While traditional irrigants like Sodium Hypochlorite (NaOCl) and EDTA remain the clinical gold standards, the field is shifting toward natural alternatives. Chitosan and Aloe Vera have recently emerged as effective herbal options, with Chitosan gaining particular attention as a promising final irrigation solution. Derived from natural sources, Chitosan is highly accessible and cost-effective. It offers a unique combination of biological and chemical benefits that address the limitations of traditional synthetic chemicals.
Chitosan, and specifically Chitosan Nanoparticles (CNPs), exhibits potent antimicrobial activity against a wide spectrum of both Gram-positive and Gram-negative bacteria. Research indicates that CNPs are highly effective at disrupting biofilms by preventing bacteria from adhering to the canal surfaces, effectively halting the development of complex microbial communities. The primary antibacterial action of Chitosan is derived from its polycationic (positively charged) nature. This charge creates a fatal attraction to the negatively charged surfaces of bacterial cells, leading to two major destructive effects.
Activation of irrigating solution by techniques as passive ultrasonic irrigation (PUI), enhances its efficacy and dynamic flow, and improves its antibacterial property and clinical outcomes.
Diabetes mellitus (DM) is defined as a multisystem complex metabolic disease that affects around 9% of the adult population. DM has two types, type 2 DM (T2DM) is caused by decreased cellular sensitivity of beta cells in islets of Langerhans of the pancreas to insulin which is referred as "insulin resistance". In general DM has an effect on the immune system that could be seen as a delay in wound healing with increased susceptibility to chronic inflammation and impaired tissue repair10.
Considering dental health, DM was reported to be the third most prevalent chronic medical condition among dental patients. Patients with DM are more liable to the development of several oral infections including fungal and bacterial infections. This is believed to be due to the decrease in salivary flow rate which in return leads to the absence of its antimicrobial effects11. DM patients have reduced beta-endorphin production which translates to higher pain perception in diabetic patients, this reduction in beta-endorphin levels might be responsible for higher pain incidence postoperatively in controlled patients12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non- surgical retreatment Novel Nanoparticle (NSRN) | Active comparator | Procedure: Novel NanoparticleAbout 14 cases will be irrigated with 5 ml of Novel Nanoparticle -Augmented irrigation placed in the root canal and activated passively with woodpecker ultrasonic (Guilin Woodpecker Medical Instrument Co., Ltd., China) for 3 cycle 20 seconds. |
| Non -surgical root canal retreatment (NSRC) | Active comparator | Procedure: Novel NanoparticleAbout 14 cases will be irrigated with 5 ml of (2.5%) NaOCl placed in the root canal and activated passively with woodpecker ultrasonic scaler (Guilin Woodpecker Medical Instrument Co., Ltd., China) for 3 cycle 20 seconds. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diabetic patients type II of either gender aged from 18-40 years
- Permanent mature Maxillary anterior teeth having a baseline periapical lesion (PAI score ≥3).
Key exclusion criteria (5 listed)
- Immuno-compromised patients.
- Pregnant women and smokers.
- Patients with a history of antibiotic or analgesics intake within the few days before the endodontic treatment.
- Teeth with root fractures or perforations.
- Teeth with lesions connected to adjacent teeth.
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 |
|---|---|---|
| Novel NanoparticleAlso: Non -Surgical Retreatment of Maxillary Anterior TeethTo evaluate efficacy of a Novel Nanoparticle -Augmented Disinfection Protocol in the Non -Surgical Retreatment of Maxillary Anterior Teeth with Periapical Lesions in Type II Diabetic Patients | Procedure or surgery | Non -surgical root canal retreatment (NSRC), Non- surgical retreatment Novel Nanoparticle (NSRN) |
Primary outcome
Post Operative Pain
Time frame: from 24 hours to 72 hours after the procedures
Evaluation of the cases from the pain after the procedures by using point numeric rating scale by another operator at 24, 48 and 72-hours.
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 2 Sep 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.
Dalia Ali Ahmed Moukarab, Professor study chair
Professor of Endodontics Head of Endodontic Department,Faculty of Dentistry,Future 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 Novel Nanoparticle in people with Post Operative 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 2 inclusion and 5 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 2 Sep 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 Ebthal Hamada Saleh, MSC (+201037570153, ebthalhamada9@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: from 24 hours to 72 hours after the procedures). 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 2 Sep 2026.