Modified Surface of PLGA Nanoparticles in Smart Hydrogel

Antibiotic Resistant Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05442736
• Other study ID #: PI (1643)
• Status: Completed
• Phase: Early Phase 1
• Start date: April 2, 2022
• Est. completion date: April 16, 2022

Study information

• Verified date: June 2022
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 16, 2022
• Est. primary completion date: April 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Infections

Intervention

Drug:
• Ciprofloxacin
studying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel

Locations

Country	Name	City	State
Egypt	Mona Arafa	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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