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Effect of Provisional-Crown Surface Coating on Biofilm Formation

Primary Purpose

Dental Plaque

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
coating a dental restoration material ,polymethylmethacrylate, with liquid polish resin
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring biofilm, adhesion, liquid polish, bonding resin, PMMA Polymethylmetacrylate, provisional crown, no antibiotics treatment three months prior to experiment, no mouth rinse with oral solutions one month prior to experiment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient in need for PMAA provisional crowns Exclusion Criteria: Patient took antibiotics three months prior to experiment

Sites / Locations

  • Hadassah Medical Organization,

Outcomes

Primary Outcome Measures

surface coating with reduced biofilm formation demonstrated by confocal scanning laser microscope and scanning electron microscope

Secondary Outcome Measures

Full Information

First Posted
November 15, 2005
Last Updated
December 10, 2007
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00254345
Brief Title
Effect of Provisional-Crown Surface Coating on Biofilm Formation
Official Title
Effect of Provisional-Crown Surface Coating on Biofilm Formation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Auto polymerizing poly methyl methacrylate (PMMA), and light initiated resin modified PMMAs, are commonly used for fabricating provisional restorations (PRs) during prosthetic treatment 1. Biofilm accumulated on these PRs may cause caries and inflammation of the surrounding tissue, tempering the outcome of the final restoration 2. Plaque adherence to temporary restorations was significantly increased compared with the untreated reference teeth 3. Biologic and physical properties of the various materials used as PRs were studied extensively 4-8 whereas their interaction with bacterial biofilm in vivo and ex vivo is less characterized. One improvement in provisional restorative materials is the use of liquid polish. It is claimed that these materials gives a high luster finish to provisional bis-acryl restorations and processed acrylic appliances, reduces or eliminates costly and time consuming polishing steps and can be used on all types of direct and indirect restorations and appliances.The effect of liquid polish coating or resin bonding coating on biofilm formation on PRs was not reported.
Detailed Description
Auto polymerizing poly methyl methacrylate (PMMA), and light initiated resin modified PMMAs, are commonly used for fabricating provisional restorations (PRs) during prosthetic treatment 1. Biofilm accumulated on these PRs may cause caries and inflammation of the surrounding tissue, tempering the outcome of the final restoration 2. Plaque adherence to temporary restorations was significantly increased compared with the untreated reference teeth 3. Biologic and physical properties of the various materials used as PRs were studied extensively 4-8 whereas their interaction with bacterial biofilm in vivo and ex vivo is less characterized. One improvement in provisional restorative materials is the use of liquid polish. It is claimed that these materials gives a high luster finish to provisional bis-acryl restorations and processed acrylic appliances, reduces or eliminates costly and time consuming polishing steps and can be used on all types of direct and indirect restorations and appliances. The effect of liquid polish coating or resin bonding coating on biofilm formation on PRs was not reported. In this study we intend to measure, in vivo early biofilm formation on PMMA PRs with and without resin coatings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
biofilm, adhesion, liquid polish, bonding resin, PMMA Polymethylmetacrylate, provisional crown, no antibiotics treatment three months prior to experiment, no mouth rinse with oral solutions one month prior to experiment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
coating a dental restoration material ,polymethylmethacrylate, with liquid polish resin
Primary Outcome Measure Information:
Title
surface coating with reduced biofilm formation demonstrated by confocal scanning laser microscope and scanning electron microscope

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient in need for PMAA provisional crowns Exclusion Criteria: Patient took antibiotics three months prior to experiment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael M Perez Davidi, DMD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
Facility Information:
Facility Name
Hadassah Medical Organization,
City
Jerusalem,
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
17694216
Citation
Perez Davidi M, Beyth N, Sterer N, Feuerstein O, Weiss EI. Effect of liquid-polish coating on in vivo biofilm accumulation on provisional restorations: part 1. Quintessence Int. 2007 Jul-Aug;38(7):591-6.
Results Reference
result
Links:
URL
http://www.mypd.co.il
Description
Michael Perez Davidi

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Effect of Provisional-Crown Surface Coating on Biofilm Formation

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