Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles

Hadassah Medical Center

Status and phase: Unknown; Phase 1

Conditions: Carcinoma of Head and Neck

Treatments: Device: polyethylenimine (PEI) nanoparticles.

Study type: Interventional

Funder types: Other

Identifiers

NCT01007240

siliconnanoHMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients post maxillectomy, who are using obturators

Exclusion criteria

• patients who are not using obturators

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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10 participants in 1 patient group

soft liner with nano particles

Experimental group

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.

Treatment:

Device: polyethylenimine (PEI) nanoparticles.