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Efficacy of a Novel Nanoparticle -Augmented Disinfection Protocol

Efficacy of a Novel Nanoparticle -Augmented Disinfection Protocol

Recruiting
18-40 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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.

Study details
    Post Operative Pain

NCT07800403

Minia University

5 September 2026

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