Dental and Periodontal Status of Patients With Sjögren's Syndrome.

Study Overview
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Brief Summary
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Sjögren's syndrome (SS) is a rare chronic systemic autoimmune disease characterized by destruction of the exocrine glands, including the salivary glands.The lack of saliva exposes the patient to dental caries, and dental wear although this has rarely been shown in Sjögren's patients. Moreover, these patients seem to have more inflammation and gingival recession, although this has not been clearly identified in the literature. Our main objective is to assess the prevalence of dental wear and gingival recession in patients with Sjögren's syndrome by analyzing of the Basic Erosive Wear Examination (BEWE) score for erosions, Basic Erosive Wear Abrasion (BEWA) score for attrition and percentage of sites with periodontal recessions greater than 3 mm in relation to the total number of sites. Our secondary objectives are to investigate a correlation between the prevalence of dental and gingival wear, gingival inflammation, Decayed, Missing, and Filled Teeth (DMFT) index and (1) salivary parameters and (2) oral quality of life. The salivary samples will be kept in a biological collection within the URP2496 for later analysis (biological collection CB-SJO).

Detailed Description
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Sjögren's syndrome (SS) is a rare chronic systemic autoimmune disease characterized by destruction of the exocrine glands, including the salivary glands leading to hyposiala. The lack of saliva exposes the patient to dental caries, and dental wear although this has rarely been described in Sjögren's patients. Moreover, these patients seem to have more inflammation and gingival recession, but not clinical attachment loss, although this has not been clearly identified in the literature. The present research focuses on the characterization of tooth wear and gingival recession prevalence in patients with Sjögren syndrome. A correlation of this parameters with salivary parameters (Xerostomia Inventory to assess the dryness, unstimulated salivary rate, stimulated salivary rate, pH and buffer capacity) will be assessed. The salivary samples will be kept in a biological collection within the URP2496 for later cross-sectional research purposes to identify salivary changes associated with increased risk of dental wear, dental caries, periodontal wear or periodontal inflammation (biological collection CB-SJO). This is a descriptive, prospective, open-label, non-interventional, single-center study with collection of salivary samples (CB-SJO) from a sample of patients with Sjögren's disease as part of the patient's routine care. Patients will be recruited in the oral medicine department of the AP-HP Charles Foix hospital (Ivry/seine). The time-line of the research is consistent with the usual patient management in oral medicine department. As Sjogren is a rare disease, we plan an inclusion period of 36 months. There is no specific follow-up due to the research.

Official Title
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Prevalence and Characteristics of Dental and Periodontal Lesions in Patients With Sjögren's Syndrome. Establishment of a Biological Saliva Collection.

Conditions
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Sjögren Syndrome

Intervention / Treatment
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* Other: Salivary samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Sjögren Syndrome Patient > 18 years old Patient affiliated to a social security system, beneficiary or beneficiary of a right other than AME Patient who speaks and understands French well enough to be able to read and understand the study information note. Patient who does not object to his participation in the study Exclusion Criteria: - Patient having expressed his opposition to participate in the research

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sjögren patients<br>Patients in specialized consultations for Sjögren's patients in the oral medicine department of the Charles Foix Hospital AP-HP France | Other: Salivary samples<br>* collection of salivary samples from Sjögren patients on routine care in the oral medicine department.NA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of dental wear and gingival recession in patients with Sjögren Syndrome | BEWE score, BEWA score, Percentage of sites with periodontal recessions greater than 3 mm of the total number of sites | 6 months once the collection is completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the prevalence of dental wear and gingival recession and (1) salivary parameters and (2) oral quality of life | OHIP-14 for the oral quality of life assessment; measure of stimulated and unstimulated flow rate, pH and buffer capacity.; measure of the oral dryness through Xerostomia Inventory | 6 months once the collection is completed | 
| Correlation between severity of the gingival inflammation and (1) salivary parameters and (2) oral quality of life. | Gingival inflammation assessed using the Bleeding On Probing score | 6 months once the collection is completed | 
| Correlation between severity of carious disease and (1) salivary parameters and (2) oral quality of life | Carious disease assessed using the DFMT index | 6 months once the collection is completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjögren syndrome, tooth wear, gingival recession