An observational study in Sjögren Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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).
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 60 months. There is 60 months (i.e. 5 years) of follow-up, this means a total research duration of 120 months (i.e. 10 years)
371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.
This study's planned enrollment of 100 is below the median of 114 across 113 observational studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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The source population consists of patients coming to consult in the oral medicine department of the Hospital of the AP-HP Charles Foix (Ivry/seine), in a specialized consultation for patients with Sjögren Gougerot syndrome created in collaboration with the Reference Center for Rare Immune Auto Diseases (including Sjögren) of the Rheumatology Department of the Bicêtre Hospital.
And patients followed in the oral medicine department of the AP-HP Charles Foix Hospital (Ivry/Seine) following oral care after the oral assessment at the Sjogren consultation
Exclusion Criteria:
Patients in specialized consultations for Sjögren's patients in the oral medicine department of the Charles Foix Hospital AP-HP France
Other: Salivary samples
collection of salivary samples from Sjögren patients on routine care in the oral medicine department.NA
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
Time frame: Once a year for 5 years
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
Time frame: Once a year for 5 years
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
Time frame: Once a year for 5 years
Correlation between severity of carious disease and (1) salivary parameters and (2) oral quality of life
Carious disease assessed using the DFMT index
Time frame: Once a year for 5 years
Plan to share: Yes — The data (age, medical history, medication, dental brushing habits, tobacco consumption, periodontal charting, number of decayed teeth, number of teeth with fillings, number of missing teeth, BEWE score, salivary data, OHIP-14 and Xerostomia Inventory score) will be collected by the investigator on the Orbis medical record or on the paper CRF. They will be transferred by the investigator of the service or a co-investigator of the service on an anonymized excel database and will be sent by secured link for repatriation to the laboratory URP2496.
Supporting information: Study protocol
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