Modified Surface of PLGA Nanoparticles in Smart Hydrogel

Early Phase 1CompletedNCT05442736

British University In Egypt55 enrolled

Overview

Nanoparticles containing antibiotic were prepared and incorporated in in situ gel to treat recurrent endodontic infections

Enterococcus faecalis is the main cause of endodontic infections and form biofilm on dentin, resulting in treatment-resistant periradicular lesions. To overcome these problems, antibacterial nanoparticles were used because of their small size, sustained release and positive charge which interact with the negatively charged surface of bacterial cell causing its destruction. In this light, Ciprofloxacin hydrochloride (CIP) in chitosan coated PLGA nanoparticles (CIP-CS-PLGA-NPs) and free CIP were embedded in Pluronic® 407/188 to form thermosensitive gels(F1) and (F2) respectively, that were investigated in terms of viscosity, gelation temperature and in-vitro release. The antibacterial efficacy of F1 and F2 were clinically investigated on patients then compared to CIP and Ca(OH)2 pastes by determining bacterial reduction percent and biofilm inhibition assay

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Antibiotic Resistant Infection

Interventions

CiprofloxacinDRUG

studying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel

Eligibility

Sex: ALLMin age: 40 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Root canal filled single rooted teeth with post treatment disease manifested by one or more of the following signs and symptoms: * History of recurrent acute and/or chronic periapical abscess * Pain on palpation and/or percussion at least after one month of previous procedure * Radiographic evidence of bone loss either as a new developing lesion or an increase in the size of a pre-existing one. Exclusion Criteria: * Teeth that were badly broken down indicated for extraction or with difficult isolation * Immuno-compromised patients. * Patients with history of taking antibiotics orally. * Periodontally affected teeth.

Locations (1)

Mona Arafa

Cairo, Egypt

Outcomes

Primary Outcomes

controlled release of the drug with associated with infection inhibition

drug entrapped in nanoparticles incorporated in in situ gel inhibited the biofilm formation and bacterial recurrent infection

Time frame: two weeks

Data from ClinicalTrials.gov

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