Viewing Study NCT00001390



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001390
Status: COMPLETED
Last Update Posted: 2018-09-24
First Post: 1999-11-03

Brief Title: Salivary Evaluation in Healthy Volunteers
Sponsor: National Institute of Dental and Craniofacial Research NIDCR
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Salivary Evaluation in Healthy Volunteers
Status: COMPLETED
Status Verified Date: 2018-09-20
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 SjSqrRootDeltagren s syndrome studies 15-D-0051 99-D-0070 11-D-0094 andor 11-D-0172

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
94-D-0018 None None None