Status:
RECRUITING
Periodontal Microbiota in Systemic Sclerosis
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Scleroderma Systemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Systemic sclerosis (SSc) is a rare and complex autoimmune disease. Although its etiology remains unknown, various environmental factors, including certain microorganisms, can represent potential trigg...
Eligibility Criteria
Inclusion
- Common inclusion criteria
- Men or women over 18 (adults)
- Affiliation to a social health insurance plan
- Subject able to understand the aims and risks of the research and to give signed informed consent form prior to the inclusion in the study
- More than 12 teeth suitable for evaluation
- Inclusion criteria for systemic sclerosis patients
- Systemic sclerosis patient with a diagnosis based on the American College of Rheumatology/European League Against Rheumatism criteria (LeRoy et al., 1988 ; van den Hoogen et al., 2013)
- Diagnosis made during the 2 years preceding study inclusion (early form of the disease)
- Inclusion criteria for controls
- \- Patient attending the Oral Medicine and Surgery Department from the University Hospital of Strasbourg for a routine dental consultation
Exclusion
- \- Subject under court protection
- Subject under guardianship or curatorship
- Pregnancy or breastfeeding
- Impossibility to provide accurate information (emergency situation, comprehension difficulties…)
- Subject currently involved in another clinical trial or in an exclusion period following participation in another clinical trial
- Smoking (≥ 10 cigarettes per day)
- Other associated systemic auto-immune disease (Sjögren syndrome with positive serum anti-SSA and/or anti-SSB auto-antibodies, systemic lupus erythematosus…)
- Progressive chronic illness other than systemic sclerosis
- Acute infection at inclusion
- Progressive cancer or cancer diagnosed within 2 years prior to the study
- Ongoing antibiotic and/or antifungal treatment or within 3 months prior to inclusion
- Probiotics and/or prebiotics intake within 3 months prior to inclusion
- Oral antiseptics within the week before inclusion (chlorhexidin mouthwashes…)
- Risk of infective endocarditis
- Corticosteroids ≥10 mg/day and/or proton pump inhibitors within 3 months prior to inclusion
- Previous hematopoietic stem cell transplantation
- Another cause of skin sclerosis (radiotherapy of the orofacial area…)
- Periodontal specialized treatments, root and/or periodontal surgical treatment and/or subgingival instrumentation within the year before inclusion
Key Trial Info
Start Date :
October 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 24 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06182293
Start Date
October 24 2024
End Date
October 24 2025
Last Update
August 6 2025
Active Locations (1)
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1
Clinique Dentaire
Strasbourg, France, 67000