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Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01007240
First Posted: November 4, 2009
Last Update Posted: November 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • bacterial growth [ Time Frame: a week ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Anat Sharon, Hadassah medical organization - maxillofacial rehabilitation department
ClinicalTrials.gov Identifier: NCT01007240     History of Changes
Other Study ID Numbers: siliconnanoHMO-CTIL
First Submitted: November 2, 2009
First Posted: November 4, 2009
Last Update Posted: November 4, 2009
Last Verified: November 2009

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-Bacterial Agents
Anti-Infective Agents