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Salivary Evaluation in Normal Volunteers



Salivary Evaluation in Normal Volunteers

For Condition: Healthy,Salivary Gland Disease
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: 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
Details: 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, eye examination and 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.
Eligibility:
Study Type:  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Participants in Normal Volunteer program No medications Good general health EXCLUSION CRITERIA: Salivary gland disease or dysfunction Sarcoidosis HIV-1 infection
Total Enrollment: 250

Location and Contact Information:

National Institute of Dental And Craniofacial Research (NIDCR) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patient  and Public Liaison Office 1-800-411-1222


Additional Information:
Study ID Numbers:  940018;  94-D-0018
Study Start Date: October 22, 1993
Record last reviewed: October 30, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001390

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