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Modified Surface of PLGA Nanoparticles in Smart Hydrogel

B

British University In Egypt

Status and phase

Completed
Early Phase 1

Conditions

Antibiotic Resistant Infection

Treatments

Drug: Ciprofloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT05442736
PI (1643)

Details and patient eligibility

About

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

Full 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

Enrollment

55 patients

Sex

All

Ages

40 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 2 patient groups

Free drug
Active Comparator group
Description:
Free drug incorporated in in situ gels
Treatment:
Drug: Ciprofloxacin
drug entrapped in nanoparticles
Active Comparator group
Description:
drug entrapped in nanoparticles then incorporated in in situ gels
Treatment:
Drug: Ciprofloxacin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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