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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04848870
Other study ID # APHP210258
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 12, 2022
Est. completion date January 12, 2025

Study information

Verified date October 2022
Source Assistance Publique - Hôpitaux de Paris
Contact Marjolaine GOSSET, PU-PH
Phone +33 6 19 39 39 01
Email marjolaine.gosset@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date January 12, 2025
Est. primary completion date January 12, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Salivary samples
collection of salivary samples from Sjögren patients on routine care in the oral medicine department.NA

Locations

Country Name City State
France Service de Médecine bucco-dentaire Ivry-sur-Seine Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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