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NCT00259181 Clinical Trial

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

Dental Plaque Clinical Trial

Official title:
Examination of the Immersion of Provisional Crown Material in Chlorhexidine Gluconate on Dental Plaque Formation in Vivo

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00259181
Other study ID # 191058HMO-CTIL
Secondary ID
Status Completed
Phase Phase 1
First received November 24, 2005
Last updated January 5, 2010
Start date January 2005

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Any volunteer without systemic condition

Exclusion Criteria:

- Intake of antibiotic drug three months prior to experiment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• saturation of polymethylmethacrylate with chlorhexidine gluconate to reduce in vivo plaque formation

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, 

Outcome
Type Measure Description Time frame Safety issue
Primary calibration of a preventative protocol for biofilm formation measured by confocal scanning laser microscope and scanning electron microscope
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