Modified Surface of PLGA Nanoparticles in Smart Hydrogel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-02

Study Completion Date

2022-04-16

Brief Summary

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

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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

Conditions

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Antibiotic Resistant Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Free drug

Free drug incorporated in in situ gels

Group Type ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type DRUG

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

drug entrapped in nanoparticles

drug entrapped in nanoparticles then incorporated in in situ gels

Group Type ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type DRUG

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

Interventions

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Ciprofloxacin

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

Intervention Type DRUG

Other Intervention Names

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device

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No