Sjogren's SyndromeNCT03327870
Oral Health Needs Assessment of Sjogren s Syndrome and Salivary Gland Dysfunction Cohorts and Healthy Volunteers Evaluating Oral Health Disparities as Determinants of Oral Health in a High-Risk Population
An observational study of Sjogren's Syndrome and Oral Health, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
Background: A person s dental health depends on many factors. Some are social, economic, or behavioral. Some are environmental. People with Sj(SqrRoot)(Delta)gren s Syndrome have a change in the amount and quality of saliva. This may affect dental health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome, Oral Health
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 16 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults classified as Sjogren's Syndrome (SS), Sicca, ISS, as well healthy volunteers as well as those excluded by the 2016 ACR/EULAR classification criteria for SS.
Who may be able to join
- Subjects enrolled in 94-D-0018, 11-D-0172, 15-D-0051 and previously enrolled in 84-D-0056 and 99-D-0070
Who cannot join
- NIH employees working at NIDCR and under the supervision of SSGDU supervisors.
- Those less than 18 years of age.
- Those unable to give consent
- Those unable to speak English or Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Oral Health Needs Assessment of Sjogren's Syndrome and Salivary Gland Dysfunction Cohorts and Healthy Volunteers - Evaluating Oral Health Disparities as Determinants of Oral Health in a High-risk Population
Background:
A person s dental health depends on many factors. Some are social, economic, or behavioral. Some are environmental. People with Sj(SqrRoot)(Delta)gren s Syndrome have a change in the amount and quality of saliva. This may affect dental health. Researchers want to study the dental health needs of people with this and other salivary gland problems. They will compare these findings with healthy volunteers. This will help them improve health care for these groups of people.
Read more
Objectives:
To study dental health needs of people with salivary gland problems and healthy volunteers. To study the disparities in dental health between these groups.
Eligibility:
Adults 18 and older who were in a Sj(SqrRoot)(Delta)gren s Syndrome study
Healthy volunteers the same age
Design:
Participants will take an online survey. It should take less than 30 minutes. They can skip any questions.
They will be asked about dental health, general health, and well-being.
Information in the survey will be kept secure.
Read the detailed description
Objective:
Determinants of health, particularly oral health, have not been evaluated in the context of Sjogren s Syndrome (SS) and other salivary gland dysfunctions. It is known that the quantitative and qualitative changes in salivary flow that occur in SS place those with this complex autoimmune disorder at increased risk of dental caries, oral infections, mucosal ulceration, salivary gland enlargement and functional impairment. There is conflicting evidence on the risk of periodontal disease in this population. Furthermore, it has been reported that this population experiences a greater number of dental visits, decayed teeth, and dental restorations in the preceding year, and have a 2-3 fold increased annual out-of pocket dental care expenditure compared to those without SS. Moreover, the oral and dental needs of those with SS have not been quantified in the context of oral health disparities, i.e., by strata of vulnerable groups. Those with other salivary gland dysfunction such as Sicca and those who have signs and symptoms of salivary gland dysfunction that only partially fulfill the classification criteria for SS, also known as incomplete SS (ISS), have neither been assessed for oral health needs nor have oral health disparities been ascertained in this high-risk population.
Study Population:
We will enroll adults classified as SS, Sicca, ISS, as well healthy volunteers as well as those excluded by the 2016 ACR/EULAR classification criteria for SS. Therefore, the aims of this study are to:
- Ascertain the oral health needs of those with SS, Sicca, and ISS in comparison with healthy volunteers (HV)
- Identify oral health disparities in this high-risk population (SS, Sicca, ISS) in comparison with HV.
Design:
This will be an observational study with a cross-sectional survey administered to the study population at enrollment, to ascertain their oral health needs and oral health disparities.
Outcome Measures:
Study participants have been evaluated and classified into SS, Sicca, ISS, and HV cohorts as part of the SS clinical protocols: 84-D-0056, 99-D-0018, 11-D-0172, 15-D-0051 and 94-D-0018.
- Primary outcome
Oral Health Outcomes will be captured using the protocols described in the NHANES Oral Health Questionnaire, with the inclusion of additional dental/oral health questions. All oral health outcomes will be ascertained once at the time of study enrollment. Self-reported oral health needs and self-reported importance of key oral health needs will be ascertained as part of the double-scaled oral health study instrument. This will enable discrepancy scoring of key oral health outcomes and calculation of a numeric needs index. These instruments have been pilot tested.
- Exposures
Oral Health Disparities will be based on indicators for the following and will be ascertained at enrollment:
- Age
- Race
- Ethnicity
- SES levels (Educational attainment, employment status, home ownership, food security)
- Geographic location (Six-level urban-rural classification scheme for U.S. counties and county-equivalent entities developed by NCHS).
- Gender
- Sexual orientation
- Marital status
- Disabilities (physical disability)
- Mental health
- Conditions
- Sjogren's Syndrome, Oral Health
- Keywords
- Sjogren's Syndrome, Sicca
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sjogren's Syndrome | |
| 2 | Sicca | |
| 3 | Incomplete Sjogren's Syndrome | |
| 4 | Healthy Volunteers | |
| 5 | Excluded by 2016 ACR/EULAR Classificastion Criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported oral health needs and importance of key oral health indicators are the outcomes
Measured: Survey completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 May 2018
- Primary completion16 Oct 2018
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Timothy J Iafolla, D.M.D., Principal investigator, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327870
- Sponsor's protocol ID
- 180007
- Other IDs
- 18-D-0007
- Status last verified
- Oct 2019
- First submitted
- 31 Oct 2017
- Last updated
- 24 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Needs Assessment of Sjogren's Syndrome and Salivary Gland Dysfunction Cohorts and Healthy Volunteers - Evaluating Oral Health Disparities as Determinants of Oral Health in a High-risk Population
- ClinicalTrials.gov ID
- NCT03327870
- Acronym / sponsor ID
- 180007
- Conditions
- Sjogren's Syndrome, Oral Health
- Keywords
- Sjogren's Syndrome, Sicca
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 1 May 2018 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
A person s dental health depends on many factors. Some are social, economic, or behavioral. Some are environmental. People with Sj(SqrRoot)(Delta)gren s Syndrome have a change in the amount and quality of saliva. This may affect dental health. Researchers want to study the dental health needs of people with this and other salivary gland problems. They will compare these findings with healthy volunteers. This will help them improve health care for these groups of people.
Objectives:
To study dental health needs of people with salivary gland problems and healthy volunteers. To study the disparities in dental health between these groups.
Eligibility:
Adults 18 and older who were in a Sj(SqrRoot)(Delta)gren s Syndrome study
Healthy volunteers the same age
Design:
Participants will take an online survey. It should take less than 30 minutes. They can skip any questions.
They will be asked about dental health, general health, and well-being.
Information in the survey will be kept secure.
Detailed description
Objective:
Determinants of health, particularly oral health, have not been evaluated in the context of Sjogren s Syndrome (SS) and other salivary gland dysfunctions. It is known that the quantitative and qualitative changes in salivary flow that occur in SS place those with this complex autoimmune disorder at increased risk of dental caries, oral infections, mucosal ulceration, salivary gland enlargement and functional impairment. There is conflicting evidence on the risk of periodontal disease in this population. Furthermore, it has been reported that this population experiences a greater number of dental visits, decayed teeth, and dental restorations in the preceding year, and have a 2-3 fold increased annual out-of pocket dental care expenditure compared to those without SS. Moreover, the oral and dental needs of those with SS have not been quantified in the context of oral health disparities, i.e., by strata of vulnerable groups. Those with other salivary gland dysfunction such as Sicca and those who have signs and symptoms of salivary gland dysfunction that only partially fulfill the classification criteria for SS, also known as incomplete SS (ISS), have neither been assessed for oral health needs nor have oral health disparities been ascertained in this high-risk population.
Study Population:
We will enroll adults classified as SS, Sicca, ISS, as well healthy volunteers as well as those excluded by the 2016 ACR/EULAR classification criteria for SS. Therefore, the aims of this study are to:
- Ascertain the oral health needs of those with SS, Sicca, and ISS in comparison with healthy volunteers (HV)
- Identify oral health disparities in this high-risk population (SS, Sicca, ISS) in comparison with HV.
Design:
This will be an observational study with a cross-sectional survey administered to the study population at enrollment, to ascertain their oral health needs and oral health disparities.
Outcome Measures:
Study participants have been evaluated and classified into SS, Sicca, ISS, and HV cohorts as part of the SS clinical protocols: 84-D-0056, 99-D-0018, 11-D-0172, 15-D-0051 and 94-D-0018.
- Primary outcome
Oral Health Outcomes will be captured using the protocols described in the NHANES Oral Health Questionnaire, with the inclusion of additional dental/oral health questions. All oral health outcomes will be ascertained once at the time of study enrollment. Self-reported oral health needs and self-reported importance of key oral health needs will be ascertained as part of the double-scaled oral health study instrument. This will enable discrepancy scoring of key oral health outcomes and calculation of a numeric needs index. These instruments have been pilot tested.
- Exposures
Oral Health Disparities will be based on indicators for the following and will be ascertained at enrollment:
- Age
- Race
- Ethnicity
- SES levels (Educational attainment, employment status, home ownership, food security)
- Geographic location (Six-level urban-rural classification scheme for U.S. counties and county-equivalent entities developed by NCHS).
- Gender
- Sexual orientation
- Marital status
- Disabilities (physical disability)
- Mental health
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Sjogren's Syndrome |
| 2 | – | –Sicca |
| 3 | – | –Incomplete Sjogren's Syndrome |
| 4 | – | –Healthy Volunteers |
| 5 | – | –Excluded by 2016 ACR/EULAR Classificastion Criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults classified as Sjogren's Syndrome (SS), Sicca, ISS, as well healthy volunteers as well as those excluded by the 2016 ACR/EULAR classification criteria for SS.
Key inclusion criteria (1 listed)
- Subjects enrolled in 94-D-0018, 11-D-0172, 15-D-0051 and previously enrolled in 84-D-0056 and 99-D-0070
Key exclusion criteria (4 listed)
- NIH employees working at NIDCR and under the supervision of SSGDU supervisors.
- Those less than 18 years of age.
- Those unable to give consent
- Those unable to speak English or Spanish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-reported oral health needs and importance of key oral health indicators are the outcomes
Time frame: Survey completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy J Iafolla, D.M.D. principal investigator
National Institute of Dental and Craniofacial Research (NIDCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome and Oral Health, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported oral health needs and importance of key oral health indicators are the outcomes (time frame: Survey completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.