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

NCT ID: NCT04848870

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2032-01-12

Brief 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).

Detailed 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 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)

Conditions

Sjögren Syndrome

Keywords

Sjögren syndrome; tooth wear; gingival recession

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sjögren patients

Patients in specialized consultations for Sjögren's patients in the oral medicine department of the Charles Foix Hospital AP-HP France

Salivary samples

Intervention Type: OTHER

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

Interventions

Salivary samples

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjolaine GOSSET, PUPH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Catherine CHAUSSAIN, PUPH

Role: STUDY_DIRECTOR

APHP

Locations

Service de Médecine bucco-dentaire

Ivry-sur-Seine, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Marjolaine GOSSET, PU-PH

Role: CONTACT

Phone: +33 6 19 39 39 01

Email: marjolaine.gosset@aphp.fr

Facility Contacts

Marjolaine Gosset, Professor

Role: primary

Franck Decup, Doctor

Role: backup

Other Identifiers

APHP210258

Identifier Type: -

Identifier Source: org_study_id