NCT00299598

Brief Summary

Resin composites withholding antibacterial properties may be useful in preventing recurrent caries. Covalently attached antibacterial polymers are a possible solution.This in vivo study would evaluated the antibacterial effect of alkylated polyethylenimine nanoparticles incorporated into flowable and hybrid composite resin disks embedded in a palatal removable appliance.The disks would be in close contact with the palate in order to check for contact mucosities. disks on the side facing the Tongue would be evaluated for their antibacterial potency with confocal laser scanning microscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 6, 2010

Status Verified

October 1, 2009

Enrollment Period

3.3 years

First QC Date

March 5, 2006

Last Update Submit

January 5, 2010

Conditions

Oral Health

Keywords

antibacterialcompositepolyethyleniminenanoparticle

Interventions

alkylated polyethylenimine nanoparticles antibacterial evaluationDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

personal of Hadassah MO

You may qualify if:

  • must be able to wear upper removable appliance

You may not qualify if:

  • gag reflex
  • infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • Matalon S, Slutzky H, Weiss EI. Surface antibacterial properties of packable resin composites: part I. Quintessence Int. 2004 Mar;35(3):189-93.

    PMID: 15119676RESULT

Related Links

Study Officials

  • Ervin I Weiss, DMD

    Hadassah Medical Organization

    STUDY CHAIR

  • Avi Domb, Phd

    Hebrew University of Jerusalem

    STUDY DIRECTOR

  • Michael M Perez Davidi, DMD

    Hadssah Medical Orgenization

    PRINCIPAL INVESTIGATOR

  • Nurit Beyth, DMD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2006

First Posted

March 7, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 6, 2010

Record last verified: 2009-10

Locations

IL(1)