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Modified Surface of PLGA Nanoparticles in Smart Hydrogel

Sponsor
British University In Egypt (Other)
Overall Status
Completed
CT.gov ID
NCT05442736
Collaborator
(none)
55
Enrollment
1
Location
2
Arms
14
Actual Duration (Days)
119.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 studyFifty-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:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 2, 2022
Actual Primary Completion Date :
Apr 16, 2022
Actual Study Completion Date :
Apr 16, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. controlled release of the drug with associated with infection inhibition [two weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 45 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mona Arafa Cairo Egypt 11841

    Sponsors and Collaborators

    • British University In Egypt

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mona Gamal Mohamed Afifi Arafa, Associate Professor, British University In Egypt
    ClinicalTrials.gov Identifier:
    NCT05442736
    Other Study ID Numbers:
    • PI (1643)
    First Posted:
    Jul 5, 2022
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mona Gamal Mohamed Afifi Arafa, Associate Professor, British University In Egypt
    nanoparticles
    endodontics infection
    Additional relevant MeSH terms:
    Infections
    Ciprofloxacin

    Study Results

    No Results Posted as of Jul 5, 2022