Bethesda, Maryland 20892


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.


Study summary:

- 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).


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.


NCT ID:

NCT00001390


Primary Contact:

Principal Investigator
Ilias G Alevizos, D.M.D.
National Institute of Dental and Craniofacial Research (NIDCR)

Lauren M Long, R.N.
Phone: (301) 594-1644
Email: longl@mail.nih.gov


Backup Contact:

Email: alevizosi@mail.nih.gov
Ilias G Alevizos, D.M.D.
Phone: (301) 496-6207


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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