Salivary Evaluation in Healthy Volunteers

Healthy Clinical Trial

Official title:

Salivary Evaluation in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001390
• Other study ID #: 940018
• Secondary ID: 94-D-0018
• Status: Completed
• Start date: October 26, 1993
• Est. completion date: September 20, 2018

Study information

• Verified date: September 20, 2018
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: September 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Healthy
• Salivary Gland Disease
• Salivary Gland Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States,