Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2009 by Hadassah Medical Organization. Recruitment status was Not yet recruiting

First Received on November 2, 2009. Last Updated on 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:	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

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
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.

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:	Dr Anat Sharon, Hadassah medical organization - maxillofacial rehabilitation department
ClinicalTrials.gov Identifier:	NCT01007240 History of Changes
Other Study ID Numbers:	siliconnanoHMO-CTIL
Study First Received:	November 2, 2009
Last Updated:	November 3, 2009
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:

Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Neoplasms, Squamous Cell
Neoplasms by Site
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012