Clinical trial NCT04848870: Dental and Periodontal Status of Patients With Sjögren's Syndrome.
Official title: Prevalence and Characteristics of Dental and Periodontal Lesions in Patients With Sjögren's Syndrome. Establishment of a Biological Saliva Collection.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sjögren Syndrome
Keywords: Sjögren syndrome
tooth wear
gingival recession
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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)

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

Primary outcomes:
measure: Prevalence of dental wear and gingival recession in patients with Sjögren Syndrome
timeFrame: Once a year for 5 years
Secondary outcomes:
measure: Correlation between the prevalence of dental wear and gingival recession and (1) salivary parameters and (2) oral quality of life
timeFrame: Once a year for 5 years
measure: Correlation between severity of the gingival inflammation and (1) salivary parameters and (2) oral quality of life.
timeFrame: Once a year for 5 years
measure: Correlation between severity of carious disease and (1) salivary parameters and (2) oral quality of life
timeFrame: Once a year for 5 years
Other outcomes:
Locations:
city: Ivry-sur-Seine
country: France
facility: Service de Médecine bucco-dentaire
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marjolaine GOSSET, PUPH
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP
name: Catherine CHAUSSAIN, PUPH
role: STUDY_DIRECTOR
References: