Dental and Periodontal Status of Patients With Sjögren's Syndrome. (CB-SJO)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Sjögren Syndrome
• Intervention / Treatment: Other: Salivary samples

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 36 months. There is no specific follow-up due to the research.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Marjolaine GOSSET, PU-PH; Phone Number: +33 6 19 39 39 01; Email: marjolaine.gosset@aphp.fr

Study Locations

• France
  • Ile De France
    • Ivry-sur-Seine, Ile De France, France, 94200
      • Recruiting
      • Service de Médecine bucco-dentaire
      • Contact: Marjolaine Gosset, Professor; Phone Number: +3369393901; Email: marjolaine.gosset@aphp.fr
      • Contact: Franck Decup, Doctor; Email: franck.decup@parisdescartes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; collection of salivary samples from Sjögren patients on routine care in the oral medicine department.NA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Marjolaine GOSSET, PUPH, Assistance Publique - Hôpitaux de Paris; Study Director: Catherine CHAUSSAIN, PUPH, APHP

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Anticipated): January 12, 2025
• Study Completion (Anticipated): January 12, 2025

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: gingival recession; tooth wear; Sjögren syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: APHP210258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No