Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles

Phase 1

• Conditions: Carcinoma of Head and Neck
• Interventions: Device: polyethylenimine (PEI) nanoparticles.

• Registration Number: NCT01007240
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-03
• Last Update Submitted: 2009-11-03
• Study First Posted: 2009-11-04
• Last Update Posted: 2009-11-04
• Study Start: 2010-01
• Primary Completion: 2010-05
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• patients post maxillectomy, who are using obturators

Exclusion Criteria

• patients who are not using obturators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
soft liner with nano particles	polyethylenimine (PEI) nanoparticles.	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.

Primary Outcome Measures

Name	Time	Method
bacterial growth	a week