Dental and Periodontal Status of Patients With Sjögren's Syndrome.
ConditionSjögren Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Salivary samples
Other interventioncollection of salivary samples from Sjögren patients on routine care in the oral medicine department.NA
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Sjögren patients1 intervention
Trial outcomes
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
Time frame
Once a year for 5 yearsSecondary outcomes
1
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
Time frame
Once a year for 5 years2
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
Time frame
Once a year for 5 years3
Correlation between severity of carious disease and (1) salivary parameters and (2) oral quality of life
Carious disease assessed using the DFMT index
Time frame
Once a year for 5 yearsSponsors and contacts
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Source ClinicalTrials.gov