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NCT Number: NCT07800403

Efficacy of a Novel Nanoparticle -Augmented Disinfection Protocol

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University, Faculty of Dentistry

Minya, Egypt

Location status: Recruiting

Location contact

Ahmed Ali Yossef, Lecturer

CONTACT

[email protected]

+201007335293

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Novel Nanoparticle

Procedure

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

Other names: Non -Surgical Retreatment of Maxillary Anterior Teeth

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia Ali Ahmed Moukarab, M.D

CONTACT

[email protected]

+201068121523

Ebthal Hamada Saleh, MSC

CONTACT

[email protected]

+201037570153

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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