Establishing Readiness of Dental Professionals in Practice-Based Research and Inter-Professional Care: Longitudinal Clinical Study
Thankam Thyvalikakath
Primary Investigator
Brief description of study
What is the purpose of this study?
The purpose of this research is to compare a group of females aged 30 years and above with pre Sjögren’s Disease conditions (fibromyalgia, joint pain, and fatigue) with a group of females 30 years and above who do not have these conditions. To do this we will use dental exams, questionnaires and saliva and blood test results to look for specific markers that might indicate susceptibility to early Sjögren’s Disease. Another purpose is to see if findings from these sources when presented to other specialists in the field help provide better health management for persons suffering from these conditions.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Study team will do a retrospective review of electronic medical records to determine which patients scheduled for future visits might meet the inclusion/exclusion criteria. Similarly for the control group, the team will do a retrospective review of electronic medical records to determine which patients scheduled for the following day might meet the inclusion/exclusion criteria for this group. Medical information will not be recorded for recruitment purposes but the name, clinic and time of appointment for those who meet the criteria will be recorded so that they may be approached by a team member from that department for potential recruitment. When approached they will be given the flyer outlining the study and, if the patient is interested in learning more, the team member will briefly describe the study to them. If they believe they would like to participate they will complete the consenting and authorization process.
Detailed description of study
What will happen during the study?
Those accepted into the study will be followed for up to three years, depending on their year of recruitment.
Following screening, participants accepted into the study in year two will complete six visits: baseline (within two to six weeks of screening) and five follow up visits, occurring once every six months.
These visits will last between 30 minutes and 2 hours depending upon consultation time, if applicable.
Those participants screened and then accepted into the study in year three will complete four visits: baseline and three follow up visits every six months.
The timing and length of the visits will be the same as described for year 2.
Those participants screened and then accepted into the study in year 4 will receive only a baseline visit and one six month follow up visit.
1. Saliva collection: Unstimulated and stimulated whole saliva (U/SWS) will be
collected biannually. The collected samples will be assessed for physical properties,
biochemical properties, and proteomics. Since saliva is an easily accessible
biospecimen amenable for frequent collection at the chairside in dental clinics,
identifying salivary biomarkers and developing a salivary diagnostic tool kit will be of
great value for early SD diagnosis.
2. Blood collection: Serum separated from peripheral blood collected biannually will be
assessed for the presence of traditional and novel SD protein markers. Traditional
markers represent reference tests for established SD
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy, Fibromyalgia, Joint pain, Chronic fatigue syndrome
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Age: 30 years - 100 years
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Gender: Female
Participant Inclusion Criteria:
Case group:
• Biological female aged ≥30 years.
• Provide a signed and dated informed consent form.
• Willing to authorize access and retrieve their electronic dental record and/or
electronic health record data available through the Indiana Network for Patient
Care (INPC), healthcare system or physician's office.
• History of fibromyalgia, joint pain or chronic fatigue syndrome for one year or
longer recorded in the electronic dental/health record as a coded diagnosis or in
the clinical notes and/or self-report a history of these conditions.
• Willing to comply with all study procedures and be available for the duration of
the study.
• Willing to provide saliva for the battery of biomarker tests.
• Willing to provide blood sample for biomarker tests.
• Willing to attend follow-up review and biospecimen collection biannually for at
least 2-3 years.
Control group:
• Biological female at birth aged ≥30 years.
• No history of fibromyalgia, joint pain, or chronic fatigue syndrome for at least one
year at the time of recruitment.
• Will provide a signed and dated informed consent form.
• Willing to authorize access and retrieve their electronic dental record and/or
electronic health record data available through the INPC, healthcare system or
physician's office.
• Willing to comply with all study procedures and be available for the duration of
the study.
• Willing to provide saliva for the biomarker tests.
• Willing to provide blood for biomarker tests.
• Willing to report for follow-up review and biospecimen collection.
Participant Exclusion Criteria:
• Individuals with previously diagnosed SD.
• Participants with ≤ 0.5 ml of unstimulated saliva at the end of five minutes of
collection during the first appointment
• Current and previous history of oral cancer.
• History of head and neck radiation treatment
• Actively undergoing chemotherapy for any cancer or taking biological
therapeutics.
• Currently taking carbonic anhydrase inhibitors
• Currently taking corticosteroids for three months or longer
• Current smoker or smoked within the past year.
• Chews tobacco daily
• Consumes more than one drink per day.
• Existing diagnosis of systemic lupus erythematosus and rheumatoid arthritis.
