NCT00256945

Brief Summary

In this study we intend to find out the pattern of biofilm accumulation in vivo on various surface finishings. Our intention is to prepare Polymethylmetacrylate squers on orthodontical brackets,then prepare the surface of the sample and measure the surface roughness with a profilimeter and get the mean value in Ra units, then place the brackets on lower premolars and molars for 12 hours, remove them and examine the biofilm formed with confocal scanning microscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2005

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

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 6, 2010

Status Verified

December 1, 2007

First QC Date

November 20, 2005

Last Update Submit

January 5, 2010

Conditions

DiabeticAntibiotic Intake

Keywords

biofilm formationdental plaquesurface roughnessdental restorationdental materials

Outcome Measures

Primary Outcomes (1)

  • confocal scanning laser microscope evaluation of biofilm formation

Secondary Outcomes (1)

  • roughness analysis of the samples with profilometer

Interventions

dental restorative material surface preparationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • any patient with intact buccal surfaces of lower molars and premolars

You may not qualify if:

  • patients that used antibiotics in the three months prior to the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • Kawai K, Urano M, Ebisu S. Effect of surface roughness of porcelain on adhesion of bacteria and their synthesizing glucans. J Prosthet Dent. 2000 Jun;83(6):664-7.

    PMID: 10842136BACKGROUND

Related Links

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Michael M Perez Davidi, DMD

    Hadassah Medical Organization

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2005

First Posted

November 22, 2005

Study Start

January 1, 2005

Study Completion

August 1, 2006

Last Updated

January 6, 2010

Record last verified: 2007-12

Locations

IL(1)