Full Text View
Tabular View
No Study Results Posted
Related Studies
Salivary Evaluation in Normal Volunteers
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), August 2009
First Received: November 3, 1999   Last Updated: November 20, 2009   History of Changes
Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001390
  Purpose

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 healthy volunteers for comparison with data from patients with salivary dysfunction. We plan to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow up, as needed. These are routine diagnostic procedures and their possible risks 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 Healthy Volunteers may be asked to participate in an MRI study of the salivary glands.


Condition
Healthy
Salivary Gland Disease

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

Resource links provided by NLM:


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

Estimated Enrollment: 250
Study Start Date: October 1993
Estimated Primary Completion Date: August 1998 (Final data collection date for primary outcome measure)
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 healthy volunteers for comparison with data from patients with salivary dysfunction. We plan to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow up, as needed. These are routine diagnostic procedures and their possible risks 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 Healthy Volunteers may be asked to participate in an MRI study of the salivary glands.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Healthy male or female volunteers from 18 to 70 years old
  • Ability to understand and sign an informed consent document.

EXCLUSION CRITERIA:

  • Known pregnancy
  • Chronic medical illness, other than well-controlled hypertension or hyperlipidemia
  • HIV, hepatitis B or C infection
  • Sicca symptoms
  • Chronic use of medications, with the exception of oral contraceptives, hormone replacement therapy, antihypertensives and antilipemics
  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
  More Information

Additional Information:
No publications provided

Study ID Numbers: 940018, 94-D-0018
Study First Received: November 3, 1999
Last Updated: November 20, 2009
ClinicalTrials.gov Identifier: NCT00001390     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Saliva
Parotid
Lip Biopsy
Health
Exocrine
Normal Volunteer

Additional relevant MeSH terms:
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases

ClinicalTrials.gov processed this record on November 27, 2009