Modified Surface of PLGA Nanoparticles in Smart Hydrogel

Early Phase 1

Completed

• Conditions: Antibiotic Resistant Infection
• Interventions: Drug: Ciprofloxacin

• Registration Number: NCT05442736
• Lead Sponsor: British University In Egypt

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

Study Timeline

• Study Start: 2022-04-02
• Primary Completion: 2022-04-16
• Study Completion: 2022-04-16
• Status Verified: 2022-06
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-28
• Last Update Submitted: 2022-06-28
• Study First Posted: 2022-07-05
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free drug	Ciprofloxacin	Free drug incorporated in in situ gels
drug entrapped in nanoparticles	Ciprofloxacin	drug entrapped in nanoparticles then incorporated in in situ gels

Primary Outcome Measures

Name	Time	Method
controlled release of the drug with associated with infection inhibition	two weeks	drug entrapped in nanoparticles incorporated in in situ gel inhibited the biofilm formation and bacterial recurrent infection

Trial Locations

Locations (1)

Mona Arafa; 🇪🇬 Cairo, Egypt