NCT04848870 Dental and Periodontal Status of Patients With Sjögren's Syndrome.
| NCT ID | NCT04848870 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Sjögren Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-01-12 |
| Primary Completion | 2032-01-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-01-12 with a primary completion date of 2032-01-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Marjolaine GOSSET, PUPH
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04848870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sjögren Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04848870 currently recruiting?
Yes, NCT04848870 is actively recruiting participants. Contact the research team at marjolaine.gosset@aphp.fr for enrollment information.
Where is the NCT04848870 trial being conducted?
This trial is being conducted at Ivry-sur-Seine, France.
Who is sponsoring the NCT04848870 clinical trial?
NCT04848870 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Marjolaine GOSSET, PUPH at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 100 participants.