Surface Roughness of a Dental Restorative Material and Biofilm Formation

Phase 1

Completed

• Conditions: Diabetic; Antibiotic Intake

• Registration Number: NCT00256945
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-11-20
• Study First Submitted QC: 2005-11-20
• Study First Posted: 2005-11-22
• Study Completion: 2006-08
• Status Verified: 2007-12
• Last Update Submitted: 2010-01-05
• Last Update Posted: 2010-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
confocal scanning laser microscope evaluation of biofilm formation

Secondary Outcome Measures

Name	Time	Method
roughness analysis of the samples with profilometer

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel