Surface Roughness of a Dental Restorative Material and Biofilm Formation

Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256945
• Other study ID #: 191057HMO-CTIL
• Status: Completed
• Phase: Phase 1
• First received: November 20, 2005
• Last updated: January 5, 2010
• Start date: January 2005
• Est. completion date: August 2006

Study information

• Verified date: December 2007
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotic Intake
• Diabetic

Intervention

Procedure:
• dental restorative material surface preparation

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	confocal scanning laser microscope evaluation of biofilm formation
Secondary	roughness analysis of the samples with profilometer

External Links

•   Michael Perez Davidi