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:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT04627857
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female ≥ 18 years (18th birthday completed)
* Affiliation to a social welfare system
* Signed informed consent form
* More than 12 natural teeth suitable for evaluation
* Systemic sclerosis with cutaneous involvement with a diagnosis based on American College of Rheumatology (ACR) and LeRoy and Metzger criteria
Exclusion Criteria:
* Localized scleroderma or systemic sclerosis without cutaneous involvement ("sine scleroderma" limited form)
* Less than 12 natural teeth suitable for evaluation and/or mandibular/maxillary complete denture(s)
* Other progressive chronic illness /autoimmune disease other than systemic sclerosis (e.g. diabetes)
* Another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region)
* Current use of sonic toothbrush and/or dental water flosser
* Severe manual handicap preventing the patient from holding a toothbrush with a large handle
* Oral antiseptics (e.g. chlorhexidin mouthwashes)
* Ongoing medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs)
* Smoking (≥ 10 cigarettes per day)
* Impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties)
* Individual under guardianship, curatorship or judicial protection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04627857
Study Brief:
Protocol Section:
NCT04627857