USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-92-245

Project Title:

Adult Fluoride Study

Principle Investigator: Dr. Gary Leske
Principle Investigator's Institution: State University of New York at Stony Brook

Project started in: 1992

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-Federal: Brookhaven National Laboratory Indirect funds

Amount: $2,000 (Est.)

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: March 01, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 430
(Reporting periods vary.)

Type of Human Subjects Involvement:

Chemical Substances:

External use of chemical substances (solid, liquid, or gas) on human subjects.

• For clinical research.

Other use of human subjects:

This study uses only fluoride mouth rinse or fluoride gel.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The purpose of this study is to determine the effectiveness of the daily use of a commercially available fluoride mouthrinse or fluoride gel in reducing dental decay in adults. A visual/tactile dental exam with no x-rays will be given initially. Subsequent examinations will be given at 16, 32 and 48 months. Approximately 500-1000 adults will be studied. The subjects will be age 45 or older with at least 15 natural teeth, at least 2 teeth with receding gums and no significant loosening of the teeth. Each subject will be studied 3 times over a 4 year period.