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Trial record 2 of 86 for:    Recruiting, Not yet recruiting, Available Studies | "Salivary Gland Diseases"

Salivary Evaluation in Healthy Volunteers

This study is currently recruiting participants.
Verified August 17, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001390
First Posted: November 4, 1999
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
  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. 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) ( National Institute of Dental and Craniofacial Research (NIDCR) ):

Estimated Enrollment: 250
Study Start Date: October 26, 1993
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).

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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: 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
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Ilias G Alevizos, D.M.D. National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

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 Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: October 19, 2017
Last Verified: August 17, 2017

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