Modified Surface of PLGA Nanoparticles in Smart Hydrogel

Study Overview
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Brief Summary
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Nanoparticles containing antibiotic were prepared and incorporated in in situ gel to treat recurrent endodontic infections

Detailed Description
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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

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

Conditions
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Antibiotic Resistant Infection

Intervention / Treatment
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* Drug: Ciprofloxacin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Free drug<br>Free drug incorporated in in situ gels | Drug: Ciprofloxacin<br>* studying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel<br>* Other names: device;|
| Active Comparator: drug entrapped in nanoparticles<br>drug entrapped in nanoparticles then incorporated in in situ gels | Drug: Ciprofloxacin<br>* studying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel<br>* Other names: device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nanoparticles, endodontics infection