Salivary Evaluation in Normal Volunteers - Full Text View

Sponsored by:	National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001390

Purpose

The purpose of this study is to collect information about normal salivary function for comparison with that of patients with salivary gland dysfunction.

Healthy normal volunteers between 20 and 70 years of age may be eligible for this study. People who have significant health problems or who are taking any medications other than birth control pills or who have a dry mouth problem may not enroll in this study.

Participants will have the following procedures:

Medical and dental history
Blood sample collection
Urine sample collection
Saliva collection - Saliva samples are collected from the parotid and submandibular/sublingual glands-the major saliva-producing glands located in the cheeks and under the jaw-using small suction devices.
Salivary gland biopsy - A biopsy (removal of small tissue sample) of the minor salivary glands in the lower lip will be done to obtain tissue for experimentation. After the biopsy site (the inner surface of the lip) is numbed with an anesthetic, an incision is made and several tiny salivary glands are removed. The wound is then closed with stitches, which will be removed at a follow-up visit

Condition
Healthy Salivary Gland Disease

MedlinePlus related topics: Salivary Gland Disorders

U.S. FDA Resources

Study Type:	Observational
Official Title:	Salivary Evaluation in Normal Volunteers

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	250
Study Start Date:	October 1993

Detailed Description:

Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated several disorders of salivary glands. The purpose of this protocol is to obtain data from normal volunteers for comparison with data from patients with salivary dysfunction. We plan to utilize the Normal Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in two outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow-up. These are routine diagnostic procedures and their possible hazards are minor. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro biochemical analysis or in vivo transplantation.

Some of the Normal Volunteers may be asked to participate in an MRI study of the salivary glands.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA:
Participants in Normal Volunteer program
No medications, with the exception of oral contraceptives or hormone replacement therapy.
Good general health

EXCLUSION CRITERIA:

Medical Illness
Blood-borne disease
Sicca symptoms

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001390

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

More Information

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Study ID Numbers:	940018, 94-D-0018
Study First Received:	November 3, 1999
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00001390
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Saliva
Parotid
Lip Biopsy

Health
Exocrine
Normal Volunteer

Study placed in the following topic categories:

Mouth Diseases
Healthy
Stomatognathic Diseases
Salivary Gland Diseases

ClinicalTrials.gov processed this record on January 15, 2009