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New treatment option for Scleroderma Systemic
Official title Periodontal Microbiota in Systemic Sclerosis
ClinicalTrials.gov ID: NCT06182293
What this study is testing
- What it's testing
- Systemic sclerosis (SSc) is a rare and complex autoimmune disease. Although its etiology remains unknown, various environmental factors, including certain microorganisms, can represent potential triggers of SSc in individuals with a permissive genetic background.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Common 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 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...
You likely can't join if
- \- 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)
See the full eligibility criteria
- Common 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 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) for controls \- Patient attending the Oral Medicine and Surgery Department from the University Hospital of Strasbourg for a routine...
- \- 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
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.