Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001852
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
1999-11-03
Brief Title:
Natural History of Salivary Gland Dysfunction and Sjogrens Syndrome
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History of Salivary Gland Dysfunction and Sjogrens Syndrome
Status:
COMPLETED
Status Verified Date:
2017-11-29
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:
This study will follow patients with salivary gland dysfunction to identify the long-term course of this disorder and its effects on the mouth oral function and overall health Saliva is important in maintaining oral health and comfort It moistens the mouth lubricates food for easier swallowing provides enzymes needed to begin the digestive process and promotes repair and cleansing of soft tissues of the mouth Decreased salivary production or changes in salivary composition may affect oral and systemic health and cause an increase in tooth decay
Patients 4 years of age and older with dry mouth symptoms and a diagnosis of primary secondary or incomplete SjSqrRootDeltagren s syndrome or salivary gland dysfunction due to radiation may be eligible for this study Candidates will be screened with a complete medical and dental history and blood and saliva tests Some patients will have a biopsy of the minor salivary glands usually from the lower lip to confirm or rule out the diagnosis of SjSqrRootDeltagren s syndrome and determine the extent of changes in the salivary glands A biopsy is the surgical removal of a small piece of tissue for laboratory examination The ability to taste and smell may also be evaluated and patients may have an ultrasound examination of their swallowing function
Participants will have a general oral examination of the teeth and soft tissues of the mouth general physical examination eye examination and blood tests and will fill out a questionnaire on oral health and function In addition they will have the following tests and procedures
Identification of possible fungal infection Patients rinse their mouth with 2 teaspoons of a salt-water solution and spit it in a sterile container for laboratory examination If a fungal infection is detected treatment will be offered
Unstimulated salivary function assessment Saliva production is measured by collecting saliva samples through small suction cups connected to collection tubes over the salivary gland ducts in the mouth
Stimulated salivary function assessment A sour-tasting liquid 2 citric acid is applied to the top and sides of the tongue at 30-second intervals to stimulation saliva production while saliva is collected using the procedure described above
Identification of markers of precancerous lesions The salivary gland biopsy done at the screening evaluation or from outside sources is examined for markers of precancerous lesions as about 5 percent of patients with SjSqrRootDeltagrens syndrome develop a tumor called Non-Hodgkin s lymphoma In some cases the minor salivary glands may be re-biopsied a few years after the screening biopsy
Patients will be followed once a year with a comprehensive history and physical examination eye examination full oral examination salivary function assessment and questionnaires about signs and symptoms of salivary gland dysfunction
Patients 4 years of age and older with dry mouth symptoms and a diagnosis of primary secondary or incomplete SjSqrRootDeltagren s syndrome or salivary gland dysfunction due to radiation may be eligible for this study Candidates will be screened with a complete medical and dental history and blood and saliva tests Some patients will have a biopsy of the minor salivary glands usually from the lower lip to confirm or rule out the diagnosis of SjSqrRootDeltagren s syndrome and determine the extent of changes in the salivary glands A biopsy is the surgical removal of a small piece of tissue for laboratory examination The ability to taste and smell may also be evaluated and patients may have an ultrasound examination of their swallowing function
Participants will have a general oral examination of the teeth and soft tissues of the mouth general physical examination eye examination and blood tests and will fill out a questionnaire on oral health and function In addition they will have the following tests and procedures
Identification of possible fungal infection Patients rinse their mouth with 2 teaspoons of a salt-water solution and spit it in a sterile container for laboratory examination If a fungal infection is detected treatment will be offered
Unstimulated salivary function assessment Saliva production is measured by collecting saliva samples through small suction cups connected to collection tubes over the salivary gland ducts in the mouth
Stimulated salivary function assessment A sour-tasting liquid 2 citric acid is applied to the top and sides of the tongue at 30-second intervals to stimulation saliva production while saliva is collected using the procedure described above
Identification of markers of precancerous lesions The salivary gland biopsy done at the screening evaluation or from outside sources is examined for markers of precancerous lesions as about 5 percent of patients with SjSqrRootDeltagrens syndrome develop a tumor called Non-Hodgkin s lymphoma In some cases the minor salivary glands may be re-biopsied a few years after the screening biopsy
Patients will be followed once a year with a comprehensive history and physical examination eye examination full oral examination salivary function assessment and questionnaires about signs and symptoms of salivary gland dysfunction
Detailed Description:
Saliva plays a major role in maintaining oral health and comfort Saliva is needed to moisten the mouth to lubricate food for easier swallowing to protect oral hard and soft tissues to modulate oral microbial populations to provide enzymes necessary to begin food breakdown for digestion and to promote soft tissue repair and oral cleansing Therefore salivary dysfunction may result in numerous clinical conditions affecting oral and systemic health comfort and quality of life In particular we will focus on individuals with SjSqrRootDeltagrens syndrome an autoimmune exocrinopathy that primarily affects the salivary and lacrimal glands A number of unanswered questions remain concerning salivary involvement in this disorder These include the rate of progression of secretory dysfunction and related oral and systemic complications associated with xerostomia in autoimmune and non-autoimmune diseases and B-cell dysregulation Also more precise estimates of the incidence of the lymphoma development are needed
The purpose of this study is 1 to allow careful follow-up of patients with defined salivary gland alterations so that the long term course and effects of SjSqrRootDeltagrens syndrome SS on the oral cavity and systemic health in SS may be delineated 2 to follow the development and progression of B-cell dysregulation in SS 3 to follow subjects to establish whether those initially manifesting incomplete criteria for SS progress toward fully meeting the criteria 4 to refine diagnostic tests for SS and to determine whether those subjects who meet the criteria for SS continue to do so and 5 to develop intermediary outcome measures for SS based on long term outcomes loss of tears and loss of stimulated salivary flow
Patients will return every two years from the baseline visit for a full oral examination salivary function assessment clinical laboratory studies and questionnaires concerning signs and symptoms of salivary gland dysfunction These individuals will be patients with SjSqrRootDeltagrens syndrome SS incomplete SS patients who have some but not all of the criteria for SS or radiation-induced salivary gland hypofunction We anticipate that many of these patients will also participate in therapeutic trials conducted within the branch
The purpose of this study is 1 to allow careful follow-up of patients with defined salivary gland alterations so that the long term course and effects of SjSqrRootDeltagrens syndrome SS on the oral cavity and systemic health in SS may be delineated 2 to follow the development and progression of B-cell dysregulation in SS 3 to follow subjects to establish whether those initially manifesting incomplete criteria for SS progress toward fully meeting the criteria 4 to refine diagnostic tests for SS and to determine whether those subjects who meet the criteria for SS continue to do so and 5 to develop intermediary outcome measures for SS based on long term outcomes loss of tears and loss of stimulated salivary flow
Patients will return every two years from the baseline visit for a full oral examination salivary function assessment clinical laboratory studies and questionnaires concerning signs and symptoms of salivary gland dysfunction These individuals will be patients with SjSqrRootDeltagrens syndrome SS incomplete SS patients who have some but not all of the criteria for SS or radiation-induced salivary gland hypofunction We anticipate that many of these patients will also participate in therapeutic trials conducted within the branch
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 |
|---|---|---|---|
| 99-D-0070 | None | None | None |