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Modified Surface of PLGA Nanoparticles in Smart Hydrogel

Modified Surface of PLGA Nanoparticles in Smart Hydrogel: A Randomized Clinical Trial to Establish an Advanced Strategy Against Antibiotic Resistant Infections in Endodontics

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05442736
Enrollment
55
Registered
2022-07-05
Start date
2022-04-02
Completion date
2022-04-16
Last updated
2022-07-05

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

Conditions

Antibiotic Resistant Infection

Keywords

nanoparticles, endodontics infection

Brief summary

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

Detailed description

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

Interventions

DRUGCiprofloxacin

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

Sponsors

British University In Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Fifty-five patients having single rooted teeth with signs and/or symptoms of post treatment disease that were indicated for non-surgical root canal retreatment were participated in this study

Eligibility

Sex/Gender
ALL
Age
40 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
controlled release of the drug with associated with infection inhibitiontwo weeksdrug entrapped in nanoparticles incorporated in in situ gel inhibited the biofilm formation and bacterial recurrent infection

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026