Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles

NCT ID: NCT01007240

Last Updated: 2009-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma of Head and Neck

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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soft liner with nano particles

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.

Group Type EXPERIMENTAL

polyethylenimine (PEI) nanoparticles.

Intervention Type DEVICE

Interventions

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polyethylenimine (PEI) nanoparticles.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients post maxillectomy, who are using obturators

Exclusion Criteria

* patients who are not using obturators
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah medical organization - maxillofacial rehabilitation department

Principal Investigators

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anat b sharon, DMD, MSc

Role: PRINCIPAL_INVESTIGATOR

lecturer, department of maxillofacial rehabilitation, hadassah medical organiztion

Central Contacts

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anat b sharon, Msc, DMD

Role: CONTACT

972-54-5255659

Other Identifiers

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siliconnanoHMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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