Modified Surface of PLGA Nanoparticles in Smart Hydrogel

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

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

Study Overview

• Status: Completed
• Conditions: Antibiotic Resistant Infection
• Intervention / Treatment: Drug: Ciprofloxacin

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11841
    • Mona Arafa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Free drug; Free drug incorporated in in situ gels	Drug: Ciprofloxacin; studying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel; Other Names: device
ACTIVE_COMPARATOR: drug entrapped in nanoparticles; drug entrapped in nanoparticles then incorporated in in situ gels	Drug: Ciprofloxacin; studying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel; Other Names: device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
controlled release of the drug with associated with infection inhibition	drug entrapped in nanoparticles incorporated in in situ gel inhibited the biofilm formation and bacterial recurrent infection	two weeks

Collaborators and Investigators

• Sponsor: British University In Egypt
• Investigators: Principal Investigator: Mona Arafa, The British University in Egypt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2022
• Primary Completion (ACTUAL): April 16, 2022
• Study Completion (ACTUAL): April 16, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (ACTUAL): July 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: nanoparticles; endodontics infection
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: PI (1643)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No