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Surface Roughness of a Dental Restorative Material and Biofilm Formation

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00256945
First received: November 20, 2005
Last updated: January 5, 2010
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic
Antibiotic Intake
 Procedure: dental restorative material surface preparation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: In Vivo Study of the Relationship Between Surface Roughness of a Dental Restorative Material and Biofilm Formation

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • confocal scanning laser microscope evaluation of biofilm formation

Secondary Outcome Measures:
  • roughness analysis of the samples with profilometer

Estimated Enrollment: 12
Study Start Date: January 2005
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256945

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Director: Michael M Perez Davidi, DMD Hadassah Medical Organization
  More Information

Additional Information:
Michael Perez Davidi  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00256945     History of Changes
Other Study ID Numbers: 191057HMO-CTIL
Study First Received: November 20, 2005
Last Updated: January 5, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
biofilm formation
dental plaque
surface roughness
dental restoration
dental materials

ClinicalTrials.gov processed this record on May 22, 2013