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Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles

Primary Purpose

Carcinoma of Head and Neck

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
polyethylenimine (PEI) nanoparticles.
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carcinoma of Head and Neck focused on measuring head and neck carcinoma, obturators, maxillectomy, soft liner, nano particles, antibacterial properties, patients post maxillectomy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients post maxillectomy, who are using obturators

Exclusion Criteria:

  • patients who are not using obturators

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    soft liner with nano particles

    Arm Description

    the obturators of this patients will be relined with soft liner, with incorporated nano particles. after a week, the soft liner will be taken off, and will be checked for bacterial adhesion.

    Outcomes

    Primary Outcome Measures

    bacterial growth

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 2009
    Last Updated
    November 3, 2009
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01007240
    Brief Title
    Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles
    Official Title
    Clinical Study of the Antibacterial Properties of the Nano Particles Which Incorporated With the Soft Liner Silicone - in Obturators
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    May 2010 (Anticipated)
    Study Completion Date
    December 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the antibacterial activity of crosslinked quaternary ammonium polyethylenimine (PEI) nanoparticles incorporated at 1-2% w/w in a commercial soft liner material when compared to the commercial soft liner material. The investigators' results in vitro showed a significant delay in bacterial growth. Therefore, the investigators assume to have the same delay in vivo- on patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma of Head and Neck
    Keywords
    head and neck carcinoma, obturators, maxillectomy, soft liner, nano particles, antibacterial properties, patients post maxillectomy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    soft liner with nano particles
    Arm Type
    Experimental
    Arm Description
    the obturators of this patients will be relined with soft liner, with incorporated nano particles. after a week, the soft liner will be taken off, and will be checked for bacterial adhesion.
    Intervention Type
    Device
    Intervention Name(s)
    polyethylenimine (PEI) nanoparticles.
    Primary Outcome Measure Information:
    Title
    bacterial growth
    Time Frame
    a week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients post maxillectomy, who are using obturators Exclusion Criteria: patients who are not using obturators
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    anat b sharon, Msc, DMD
    Phone
    972-54-5255659
    Email
    anatsharon@hadassah.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    anat b sharon, DMD, MSc
    Organizational Affiliation
    lecturer, department of maxillofacial rehabilitation, hadassah medical organiztion
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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