Completed

Salivary Evaluation in Healthy Volunteers

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What is being collected

Data Collection

Who is being recruted

Stomatognathic Diseases

+ Mouth Diseases

+ Salivary Gland Diseases

From 18 to 70 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Observational
Study Start: October 1993
See protocol details

Summary

Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: September 24, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: October 26, 1993

Actual date on which the first participant was enrolled.

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).

NCT00001390
Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: September 24, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

173 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Stomatognathic DiseasesMouth DiseasesSalivary Gland Diseases

Criteria

5 exclusion criteria prevent from participating
NIH employees who are subordinates/relatives/co-workers of investigators.

Have problems with dry mouth and/or dry eyes.

Chronic medical illness, other than well-controlled hypertension or hyperlipidemia.

Known pregnancy.

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center