We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surface Roughness of a Dental Restorative Material and Biofilm Formation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00256945
First Posted: November 22, 2005
Last Update Posted: January 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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
Intervention Model: Single Group Assignment
Masking: Single
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00256945     History of Changes
Other Study ID Numbers: 191057HMO-CTIL
First Submitted: November 20, 2005
First Posted: November 22, 2005
Last Update Posted: January 6, 2010
Last Verified: December 2007

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