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Modified Surface of PLGA Nanoparticles in Smart Hydrogel

Primary Purpose

Antibiotic Resistant Infection

Status

Completed

Phase

Early Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Ciprofloxacin

About this trial

This is an interventional treatment trial for Antibiotic Resistant Infection focused on measuring nanoparticles, endodontics infection

Eligibility Criteria

40 Years - 45 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Mona Arafa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Free drug

drug entrapped in nanoparticles

Arm Description

Free drug incorporated in in situ gels

drug entrapped in nanoparticles then incorporated in in situ gels

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05442736

First Posted

June 27, 2022

Last Updated

June 28, 2022

Sponsor

British University In Egypt

1. Study Identification

Unique Protocol Identification Number

NCT05442736

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

April 2, 2022 (Actual)

Primary Completion Date

April 16, 2022 (Actual)

Study Completion Date

April 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

British University In Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Antibiotic Resistant Infection

Keywords

nanoparticles, endodontics infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

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

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Free drug

Arm Type

Active Comparator

Arm Description

Free drug incorporated in in situ gels

Arm Title

drug entrapped in nanoparticles

Arm Type

Active Comparator

Arm Description

drug entrapped in nanoparticles then incorporated in in situ gels

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin

Other Intervention Name(s)

device

Intervention Description

studying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel

Primary Outcome Measure Information:

Title

controlled release of the drug with associated with infection inhibition

Description

drug entrapped in nanoparticles incorporated in in situ gel inhibited the biofilm formation and bacterial recurrent infection

Time Frame

two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mona Arafa

Organizational Affiliation

The British University in Egypt

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mona Arafa

City

Cairo

ZIP/Postal Code

11841

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32393082

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.

Results Reference

result

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Modified Surface of PLGA Nanoparticles in Smart Hydrogel

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