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NCT00254345 Clinical Trial

Effect of Provisional-Crown Surface Coating on Biofilm Formation

Dental Plaque Clinical Trial

Official title:
Effect of Provisional-Crown Surface Coating on Biofilm Formation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00254345
Other study ID # 191056HMO-CTIL
Secondary ID
Status Completed
Phase Phase 1
First received November 15, 2005
Last updated December 10, 2007
Start date September 2006
Est. completion date April 2007

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

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient in need for PMAA provisional crowns

Exclusion Criteria:

- Patient took antibiotics three months prior to experiment

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• coating a dental restoration material ,polymethylmethacrylate, with liquid polish resin

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)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary surface coating with reduced biofilm formation demonstrated by confocal scanning laser microscope and scanning electron microscope
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