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Completed

NCT Number: NCT05442736

Modified Surface of PLGA Nanoparticles in Smart Hydrogel

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

Completed

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Key information

Conditions

Antibiotic Resistant Infection

Age range

40 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mona Arafa

Cairo, 11841, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciprofloxacin

Drug

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

Other names: device

Primary outcomes

  1. controlled release of the drug with associated with infection inhibition

    Time frame: two weeks

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

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2022
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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