Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles

This study is not yet open for participant recruitment.

Verified by Hadassah Medical Organization, November 2009

First Received: November 2, 2009 Last Updated: November 3, 2009 History of Changes

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT01007240

Purpose

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.

Condition	Intervention	Phase
Carcinoma of Head and Neck	Device: polyethylenimine (PEI) nanoparticles.	Phase I

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Clinical Study of the Antibacterial Properties of the Nano Particles Which Incorporated With the Soft Liner Silicone - in Obturators

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

bacterial growth [ Time Frame: a week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
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)

Arms	Assigned Interventions
soft liner with nano particles: Experimental 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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients post maxillectomy, who are using obturators

Exclusion Criteria:

patients who are not using obturators

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007240

Contacts

Contact: anat b sharon, Msc, DMD

972-54-5255659

anatsharon@hadassah.org.il

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

anat b sharon, DMD, MSc

lecturer, department of maxillofacial rehabilitation, hadassah medical organiztion

More Information

No publications provided

Responsible Party:	Hadassah medical organization - maxillofacial rehabilitation department ( Dr Anat Sharon )
Study ID Numbers:	siliconnanoHMO-CTIL
Study First Received:	November 2, 2009
Last Updated:	November 3, 2009
ClinicalTrials.gov Identifier:	NCT01007240 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:

head and neck carcinoma
obturators
maxillectomy
soft liner

nano particles
antibacterial properties
patients post maxillectomy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Neoplasms
Neoplasms by Histologic Type
Therapeutic Uses

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Pharmacologic Actions
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 20, 2009