A Protocol for the Use of Chlorhexidine Gluconate Saturation for the Reduction of Dental Biofilm Formation on Polymethylmethacrylate Restoration
Primary Purpose
Dental Plaque
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
saturation of polymethylmethacrylate with chlorhexidine gluconate to reduce in vivo plaque formation
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque focused on measuring chlorhexidine gluconate, polymethylmethacrylate, Anti-Bacterial Agents
Eligibility Criteria
Inclusion Criteria: Any volunteer without systemic condition Exclusion Criteria: Intake of antibiotic drug three months prior to experiment
Sites / Locations
- Hadassah Medical Organization
Outcomes
Primary Outcome Measures
calibration of a preventative protocol for biofilm formation measured by confocal scanning laser microscope and scanning electron microscope
Secondary Outcome Measures
Full Information
NCT ID
NCT00259181
First Posted
November 24, 2005
Last Updated
January 5, 2010
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00259181
Brief Title
A Protocol for the Use of Chlorhexidine Gluconate Saturation for the Reduction of Dental Biofilm Formation on Polymethylmethacrylate Restoration
Official Title
Examination of the Immersion of Provisional Crown Material in Chlorhexidine Gluconate on Dental Plaque Formation in Vivo
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
Brief Summary
Chlorhexidine gluconate (CHX), as an anti plaque agent, is commonly used with a variety of products. In this study we, the investigators at Hadassah Medical Organization, intend to examine the efficacy of a single dip in CHX of provisional restoration prior to oral cementation. If the protocol is effective, we intend to calibrate it and recommend clinical use of the protocol. The examination of biofilm formation will be both with electron microscope and confocal scanning laser microscope.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
chlorhexidine gluconate, polymethylmethacrylate, Anti-Bacterial Agents
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
saturation of polymethylmethacrylate with chlorhexidine gluconate to reduce in vivo plaque formation
Primary Outcome Measure Information:
Title
calibration of a preventative protocol for biofilm formation measured by confocal scanning laser microscope and scanning electron microscope
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any volunteer without systemic condition
Exclusion Criteria:
Intake of antibiotic drug 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
Links:
URL
http://www.mypd.co.il
Description
Michael Perez Davidi
Learn more about this trial
A Protocol for the Use of Chlorhexidine Gluconate Saturation for the Reduction of Dental Biofilm Formation on Polymethylmethacrylate Restoration
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