Healthy Clinical Trial in Bethesda MD
NCT00001390
| Observational
This study has recruited 173 Participants
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.
Details for the study
Brief Title
Salivary Evaluation in Healthy Volunteers
Official Title
Salivary Evaluation in Healthy Volunteers
Brief Summary
Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated<br /> several disorders of salivary glands. The purpose of this protocol is to obtain data from<br /> healthy volunteers for comparison with data from patients with salivary dysfunction. We plan<br /> to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid<br /> participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits<br /> that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry<br /> eye examination, and lip biopsy follow up, as needed. These are routine diagnostic<br /> procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro<br /> biochemical analysis or in vivo transplantation.<br /><br /> Some of the Healthy Volunteers may be asked to participate in an MRI study of the salivary<br /> glands.
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 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.