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

This study has been completed.

First Received on November 24, 2005. Last Updated on January 5, 2010 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	Examination of the Immersion of Provisional Crown Material in Chlorhexidine Gluconate on Dental Plaque Formation in Vivo

Resource links provided by NLM:

MedlinePlus related topics: Nuclear Scans

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Hibiclens Gluconic acid D-Gluconic acid, monosodium salt Manganese gluconate

U.S. FDA Resources

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

Additional Information:

Michael Perez Davidi This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00259181 History of Changes
Other Study ID Numbers:	191058HMO-CTIL
Study First Received:	November 24, 2005
Last Updated:	January 5, 2010
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

chlorhexidine gluconate
polymethylmethacrylate
Anti-Bacterial Agents

Additional relevant MeSH terms:

Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Polymethyl Methacrylate
Chlorhexidine gluconate
Chlorhexidine
Vasodilator Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Disinfectants

ClinicalTrials.gov processed this record on February 12, 2012