NCT00502606

Brief Summary

The effect of Antibacterial Nanoparticles, Incorporated in cement, on S.mutans in the margins of provisional restorations is going to be examined clinically by using two kinds of provisional cement 1. cement with out antibacterial nanoparticles. 2.cement with small addition of IABN. after one week in the mouth the crowns are to be removed and examined for the presence and quantity of s. mutans. in vitro tests of the same has shown significant reduction in bacterial population around the provisional cement as compared to the regular cement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 6, 2010

Status Verified

October 1, 2009

Enrollment Period

3.8 years

First QC Date

July 16, 2007

Last Update Submit

January 5, 2010

Conditions

Oral RehabilitaitonCariesPeriodontitis

Keywords

provisional restorationantibacterial nanoparticlescementbiofilmbacteriafloraplaquedentalprosthesis

Study Arms (1)

patients with provisional crowns

the same patient would serve as control and test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hadassah dental patients

You may qualify if:

  • Patients who need provisional restorations.

You may not qualify if:

  • Patients who got antibacterial therapy in the past 3 months.
  • Patients using chlorhexidine gluconate.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization,

Jerusalem, Israel

Location

Related Publications (1)

  • Beyth N, Yudovin-Farber I, Bahir R, Domb AJ, Weiss EI. Antibacterial activity of dental composites containing quaternary ammonium polyethylenimine nanoparticles against Streptococcus mutans. Biomaterials. 2006 Jul;27(21):3995-4002. doi: 10.1016/j.biomaterials.2006.03.003. Epub 2006 Mar 27.

    PMID: 16564083RESULT

Related Links

MeSH Terms

Conditions

PeriodontitisPlaque, Amyloid

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Perez Davidi, DMD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Nir Sterer, DMD PhD

    Hadassah Medical Organization

    STUDY DIRECTOR

  • Ervin Weiss, DMD

    Hadassah Medical Organization

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

January 6, 2010

Record last verified: 2009-10

Locations

IL(1)