Salivary Evaluation in Normal Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001390
First received: November 3, 1999
Last updated: May 23, 2014
Last verified: March 2014
  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 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 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 Healthy 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
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. 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.

The outcome measurement for this study is to determine those healthy subjects whose

data and specimens can be used as control comparison for our patient subjects in our

Sj(SqrRoot)(Delta)gren s syndrome studies (84-D-0056, 99-D-0070, 11-D-0094 and/or 11-D-0172).

  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
  • Chronic use of medications, with the exception of oral contraceptives, hormone

replacement therapy, antihypertensives and antilipemics.

- Have problems with dry mouth and/or dry eyes.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Lolita Bebris, R.N. (301) 594-1644 bebrisl@mail.nih.gov
Contact: Ilias G Alevizos, D.M.D. (301) 496-6207 alevizosi@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Ilias G Alevizos, D.M.D. National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

Additional Information:
No publications provided by National Institutes of Health Clinical Center (CC)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00001390     History of Changes
Other Study ID Numbers: 940018, 94-D-0018
Study First Received: November 3, 1999
Last Updated: May 23, 2014
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:
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 22, 2014