- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00254345
Effect of Provisional-Crown Surface Coating on Biofilm Formation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Jerusalem,, Israel, 91120
- Hadassah Medical Organization,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient in need for PMAA provisional crowns
Exclusion Criteria:
- Patient took antibiotics three months prior to experiment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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surface coating with reduced biofilm formation demonstrated by confocal scanning laser microscope and scanning electron microscope
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Michael M Perez Davidi, DMD, Hadassah Medical Organization
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 191056HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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