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Efficacy of a Novel Nanoparticle -Augmented Disinfection Protocol

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07800403
Enrollment
28
Registered
2026-09-02
Start date
2026-07-14
Completion date
2027-07-14
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Brief 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. 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.

Interventions

PROCEDURENovel Nanoparticle

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

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post Operative Painfrom 24 hours to 72 hours after the proceduresEvaluation of the cases from the pain after the procedures by using point numeric rating scale by another operator at 24, 48 and 72-hours.

Countries

Egypt

Contacts

CONTACTEbthal Hamada Saleh, MSC
ebthalhamada9@gmail.com+201037570153
CONTACTDalia Ali Ahmed Moukarab, M.D
dalia.mokarab@mu.edu.eg+201068121523
STUDY_CHAIRDalia Ali Ahmed Moukarab, Professor

Professor of Endodontics Head of Endodontic Department,Faculty of Dentistry,Future University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026