Clinical trial NCT05442736: Modified Surface of PLGA Nanoparticles in Smart Hydrogel
Official title: Modified Surface of PLGA Nanoparticles in Smart Hydrogel: A Randomized Clinical Trial to Establish an Advanced Strategy Against Antibiotic Resistant Infections in Endodontics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Antibiotic Resistant Infection
Keywords: nanoparticles
endodontics infection
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: controlled release of the drug with associated with infection inhibition
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mona Arafa
Study officials:
affiliation: The British University in Egypt
name: Mona Arafa
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fereig SA, El-Zaafarany GM, Arafa MG, Abdel-Mottaleb MMA. Tackling the various classes of nano-therapeutics employed in topical therapy of psoriasis. Drug Deliv. 2020 Dec;27(1):662-680. doi: 10.1080/10717544.2020.1754527.