Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles
Recruitment status was Not yet recruiting
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.
Carcinoma of Head and Neck
Device: polyethylenimine (PEI) nanoparticles.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Clinical Study of the Antibacterial Properties of the Nano Particles Which Incorporated With the Soft Liner Silicone - in Obturators|
- bacterial growth [ Time Frame: a week ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: 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.
|Device: polyethylenimine (PEI) nanoparticles.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007240
|Contact: anat b sharon, Msc, DMDfirstname.lastname@example.org|
|Principal Investigator:||anat b sharon, DMD, MSc||lecturer, department of maxillofacial rehabilitation, hadassah medical organiztion|