Modified Surface of PLGA Nanoparticles in Smart Hydrogel: A Randomized Clinical Trial to Establish an Advanced Strategy Against Antibiotic Resistant Infections in Endodontics
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- British University In Egypt
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- controlled release of the drug with associated with infection inhibition
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Free drug
Free drug incorporated in in situ gels
Intervention: Ciprofloxacin (Drug)
drug entrapped in nanoparticles
drug entrapped in nanoparticles then incorporated in in situ gels
Intervention: Ciprofloxacin (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Mona Gamal Mohamed Afifi Arafa
Associate Professor
British University In Egypt