Surface Roughness of a Dental Restorative Material and Bi... | NCT00256945

Studies
Surface Roughness of a Dental Restorative Material and Biofilm Formation

NCT00256945

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Jan 6, 2010Estimated

Enrollment

Phase

Phase 1

Conditions

Diabetic
Antibiotic Intake

Interventions

dental restorative material surface preparation

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Aug 2006

First Submitted Date

Nov 20, 2005

First Submission Date that Met QC Criteria

Nov 20, 2005

First Posted Date

Nov 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2010

Last Update Posted Date

Jan 6, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
dental restorative material surface preparation	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
confocal scanning laser microscope evaluation of biofilm formation

Secondary Outcomes

Measure	Description	Time Frame
roughness analysis of the samples with profilometer

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael M Perez Davidi, DMD	Hadassah Medical Organization	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem		91120	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10842136	Background	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.

ID	Term
D003741	Dental Deposits
D014076	Tooth Diseases
D009057	Stomatognathic Diseases