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

NCT04848870 | Recruiting

• 1 other identifier: APHP210258
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Sjögren Syndrome

Keywords

Sjögren syndrome; tooth wear; gingival recession

Outcome Measures

Primary Outcomes (1)

• 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

  Once a year for 5 years

Secondary Outcomes (3)

• Correlation between the prevalence of dental wear and gingival recession and (1) salivary parameters and (2) oral quality of life

  Once a year for 5 years

• Correlation between severity of the gingival inflammation and (1) salivary parameters and (2) oral quality of life.

  Once a year for 5 years

• Correlation between severity of carious disease and (1) salivary parameters and (2) oral quality of life

  Once a year for 5 years

Study Arms (1)

Sjögren patients

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

Other: Salivary samples

Interventions

Salivary samples OTHER

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

Sjögren patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- Patient having expressed his opposition to participate in the research

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine bucco-dentaire

Ivry-sur-Seine, Île-de-France Region, 94200, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Sjogren's Syndrome; Tooth Wear; Gingival Recession

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Tooth Diseases; Gingival Diseases; Periodontal Diseases; Periodontal Atrophy

Study Officials

• Marjolaine GOSSET, PUPH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Catherine CHAUSSAIN, PUPH

  APHP

  STUDY DIRECTOR

Central Study Contacts

Marjolaine GOSSET, PU-PH

CONTACT

+33 6 19 39 39 01; marjolaine.gosset@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: January 12, 2022
• Primary Completion (Estimated): January 12, 2032
• Study Completion (Estimated): January 12, 2032
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

FR (1)