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Clinical Trials/NCT00256945
NCT00256945
Completed
Phase 1

In Vivo Study of the Relationship Between Surface Roughness of a Dental Restorative Material and Biofilm Formation

Hadassah Medical Organization1 site in 1 country12 target enrollmentJanuary 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diabetic
Sponsor
Hadassah Medical Organization
Enrollment
12
Locations
1
Primary Endpoint
confocal scanning laser microscope evaluation of biofilm formation
Status
Completed
Last Updated
16 years ago

Overview

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.

Detailed Description

Several studies in the past to assess the effects of surface roughness on the amount of plaque accumulation in vitro, whereas only few performed a modern in vitro assessment of the plaque accumulation. 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. Statistical evaluation of pilot study determined the need to perform this research on twelve(12) candidates. It is our intention to check two materials in each candidate: composite resin and polymethylmetacrylate.

Registry
clinicaltrials.gov
Start Date
January 2005
End Date
August 2006
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

confocal scanning laser microscope evaluation of biofilm formation

Secondary Outcomes

  • roughness analysis of the samples with profilometer

Study Sites (1)

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