Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT06182293
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
* \- 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06182293
Study Brief:
Protocol Section:
NCT06182293