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A Protocol for the Use of Chlorhexidine Gluconate Saturation for the Reduction of Dental Biofilm Formation on Polymethylmethacrylate Restoration

This study has been completed.

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00259181
  Purpose

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.


Condition Intervention Phase
Dental Plaque
Procedure: saturation of polymethylmethacrylate with chlorhexidine gluconate to reduce in vivo plaque formation
Phase I

MedlinePlus related topics:   Nuclear Scans   

ChemIDplus related topics:   Chlorhexidine    Chlorhexidine digluconate    D-Gluconic acid, monosodium salt    Gluconic acid    Manganese gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:   Examination of the Immersion of Provisional Crown Material in Chlorhexidine Gluconate on Dental Plaque Formation in Vivo

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • calibration of a preventative protocol for biofilm formation measured by confocal scanning laser microscope and scanning electron microscope

Estimated Enrollment:   12
Study Start Date:   January 2005

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Any volunteer without systemic condition

Exclusion Criteria:

  • Intake of antibiotic drug three months prior to experiment
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259181

Locations
Israel
Hadassah Medical Organization    
      Jerusalem, Israel, 91120

Sponsors and Collaborators
Hadassah Medical Organization

Investigators
Study Director:     Michael M Perez Davidi, DMD     Hadassah Medical Organization    
  More Information

Michael Perez Davidi  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   191058HMO-CTIL
First Received:   November 24, 2005
Last Updated:   December 10, 2007
ClinicalTrials.gov Identifier:   NCT00259181
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
chlorhexidine gluconate  
polymethylmethacrylate  
Anti-Bacterial Agents  

Study placed in the following topic categories:
Polymethyl Methacrylate
Tooth Diseases
Chlorhexidine
Chlorhexidine gluconate
Stomatognathic Diseases
Dental Plaque

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Vasodilator Agents
Dental Deposits
Therapeutic Uses
Physiological Effects of Drugs
Antimutagenic Agents
Cardiovascular Agents
Dermatologic Agents
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2008




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