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Salivary Evaluation in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00001390
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

Brief Summary:

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.


Condition or disease
Healthy Salivary Gland Disease

Detailed Description:
  • Objective: To obtain data from healthy volunteers for comparison with data from patients with salivary dysfunction.
  • Study population: Healthy volunteers aged 18-70 years old
  • Design: Observational
  • Outcome measures: Clinical and basic science data to serve as controls for comparisons with subjects presenting with salivary gland dysfunction

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 (15-D-0051, 99-D-0070, 11-D-0094 and/or 11-D-0172).


Study Type : Observational
Estimated Enrollment : 250 participants
Official Title: Salivary Evaluation in Healthy Volunteers
Study Start Date : October 26, 1993

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  • NIH employees who are subordinates/relatives/co-workers of investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001390


Contacts
Contact: Lauren M Long, R.N. (301) 594-1644 longl@mail.nih.gov
Contact: Blake M Warner, D.D.S. (301) 496-4486 blake.warner@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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Blake M Warner, D.D.S. National Institute of Dental and Craniofacial Research (NIDCR)

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00001390     History of Changes
Other Study ID Numbers: 940018
94-D-0018
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 8, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Saliva
Parotid
Lip Biopsy
Health
Exocrine
Normal Volunteer

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