Antibacterial Properties of Silicon Incorporated With Qua... | NCT01007240

Studies
Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles

NCT01007240

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Nov 4, 2009Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Carcinoma of Head and Neck

Interventions

polyethylenimine (PEI) nanoparticles.

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

May 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Nov 2, 2009

First Submission Date that Met QC Criteria

Nov 3, 2009

First Posted Date

Nov 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2009

Last Update Posted Date

Nov 4, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
polyethylenimine (PEI) nanoparticles.	Device		soft liner with nano particles

Measure	Description	Time Frame
bacterial growth		a week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients post maxillectomy, who are using obturators

Exclusion Criteria:

patients who are not using obturators

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
anat b sharon, Msc, DMD	Contact	972-54-5255659		anatsharon@hadassah.org.il

Overall Officials

Name	Affiliation	Role
anat b sharon, DMD, MSc	lecturer, department of maxillofacial rehabilitation, hadassah medical organiztion	Principal Investigator

Locations

Not provided