University of California, San Francisco

Funding for Human Subjects Research:

Federal: National Institutes of Health (NIH)

$1,176,931.00 for: Fiscal Year 2005
Percent of funding associated with the use of human subjects: 1-20

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Identifier or number: 77816

Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of California, San Francisco
Most recent approval: 02/15/05
IRB approval number: H5687-04447-17

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 19
Reporting period for number of human subjects: Year prior to last IRB approval date

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

• Using existing specimens or samples of bodily materials collected for another purpose.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using data collected from subjects specifically for this project.
• Using existing data that were collected for other purposes or projects.

(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])

Purpose:
The research seeks to resolve the contradictions surrounding the structure and properties of dental hard tissues with the goal of developing more conservative treatment options for dental caries. As part of this research, we use the hard x-ray beamlines at the Stanford Synchrotron Radiation Laboratory and Advanced Light Source at Lawrence Berkeley National Laboratory for x-ray characterization of these hard tissues. Two primary techniques are x-ray microtomography, which is used to characterize the microstructure and mineral concentration, and x-ray small angle scattering, which is used to probe the mineral/collagen binding in these tissues. From these studies, we hope to develop a better understanding of biomineralization of dental tissues and to develop techniques for restoring affected carious tissues.

Methodology:
This project will involve subjects who are patients that have teeth scheduled for extraction for clinical reasons at the University of California, San Francisco (UCSF) clinics. Prior to extraction of teeth, the patient will be asked by the supervising dentist if they would like to participate in a research study at the UCSF School of Dentistry by donating the extracted tooth to a project to characterize dentin. Each patient who agrees to participate will be paid $15 for his or her cooperation. Each subject will sign a consent form that has been approved by the UCSF Committee on Human Research. By agreeing to participate in this project, each subject is agreeing to release his or her extracted tooth to the principal investigator, to complete questionnaires concerning fluoride history, and to release the principal investigator from any liability related to procedures for collecting teeth or any subsequent changes in their dental status. Participation in this study will take an additional ten minutes in order to complete a history form. There will be no patient contact with researchers from UCSF, nor will there be any patient contact with employees of the Stanford Synchrotron Radiation Laboratory.

Human teeth will be used in this study. The subjects will be drawn from the general patient population of the UCSF dental clinics who require extraction of one or more teeth.

Risk:
There are no physical risks involved beyond normal dental treatment. All records, fluoride histories, and teeth will be coded for anonymity. These will be accessible only to project personnel transferring data to computer files and to the principal investigator. Signed consent forms will be stored in a locked area and will be accessible only to the principal investigator and to Dr. G. Marshall, who is responsible for tooth collection. Anyone who does not wish to complete the fluoride history form may withdraw from the study at any time. Patients will not be individually identified in any publications resulting from this study.

Benefits:
There is no direct benefit to the subject. The benefit to society at large is that a better restorative material system may be developed as a result of this project.