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

Sjögren Syndrome Clinical Trial

— CB-SJO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04848870
• Other study ID #: APHP210258
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Sjögren Syndrome
• Sjogren's Syndrome
• Syndrome

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