AzTrials
AzTrials

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.

Recruiting

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

Sites and contacts
Official record
Search all trials

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.

Ebthal Hamada Saleh, MSC contact

+201037570153

ebthalhamada9@gmail.com

Dalia Ali Ahmed Moukarab, M.D contact

+201068121523

dalia.mokarab@mu.edu.eg

Egypt1 site, 1 recruiting
  • Minia University, Faculty of Dentistry

    Minya

    Ahmed Ali Yossef, Lecturer, +201007335293, ahmed.yousef@mu.edu.eg

    Recruiting

Other trials in Egypt

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.

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 groups in NCT07800403
Study groupRoleWhat they receive
Non- surgical retreatment Novel Nanoparticle (NSRN)Active comparatorAbout 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 comparatorAbout 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.

  1. 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.

  1. First posted2 Sep 2026
  2. Study start14 Jul 2026
  3. Primary completion7 Jul 2027 (estimated)
  4. Study completion14 Jul 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
28 participants (estimated)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in