USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-92-065-H01

Project Title:

Leukocyte Function in Periodontal Disease (see LBL-93-10-68 in 1994 database)

Principle Investigator: Dr. John Maguire

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: University of California, San Francisco

Amount: $12,000 (Est.)
Comments:

UCSF Subcontract: "The Oxidant and Antioxidant Balance in Wounds"

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: January 05, 1995
IRB Approval Number: 94-10-57

Number of Human Subjects in the Last Reporting Period for this Project: 20
(Reporting periods vary.)

Type of Human Subjects Involvement:

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

(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])

OBJECTIVES

The objective of this study is to investigate whether inducible nitric oxide production from neutrophils and macrophages plays a role in the development of periodontal diseases. This study will also test the hypothesis that inducible nitric oxide production is important in bacteriocidal activity. This information will aid in the management of patient cases involving periodontal diseases.

METHODOLOGY

Leukocytes and neutrophils are collected from human subjects by either rinsing the mouth with saline, from blood (venipuncture), or from surgical drain fluid obtained during surgeries conducted at the University of California, San Francisco. Human leukocytes and neutrophils are assessed for production and induction of nitric oxide; both leukocytes and neutrophils will be tested under normoxic, neutral, hypoxic and acidic conditions in vitro. Normal samples are contrasted to samples from subjects with periodontal disease.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

There is no risk to subjects rinsing with saline. Venipuncture risks include bruising, faintness, and a remote chance of infection. The drain fluids are surgical discards and cause no additional risk to the patient.