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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04848870
Acronym
CB-SJO
Enrollment
100
Registered
2021-04-19
Start date
2022-01-12
Completion date
2032-01-12
Last updated
2024-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjögren Syndrome

Keywords

Sjögren syndrome, tooth wear, gingival recession

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)

Interventions

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of dental wear and gingival recession in patients with Sjögren SyndromeOnce a year for 5 yearsBEWE score, BEWA score, Percentage of sites with periodontal recessions greater than 3 mm of the total number of sites

Secondary

MeasureTime frameDescription
Correlation between the prevalence of dental wear and gingival recession and (1) salivary parameters and (2) oral quality of lifeOnce a year for 5 yearsOHIP-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
Correlation between severity of the gingival inflammation and (1) salivary parameters and (2) oral quality of life.Once a year for 5 yearsGingival inflammation assessed using the Bleeding On Probing score
Correlation between severity of carious disease and (1) salivary parameters and (2) oral quality of lifeOnce a year for 5 yearsCarious disease assessed using the DFMT index

Countries

France

Contacts

Primary ContactMarjolaine GOSSET, PU-PH
marjolaine.gosset@aphp.fr+33 6 19 39 39 01

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026