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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT02371005
Eligibility Criteria:
Inclusion Criteria:
* Common inclusion criteria
* Males and females ≥ 18 years (18th birthday completed)
* Affiliation to a social security scheme
* Signed informed consent form prior to inclusion in the study
* More than 12 natural teeth suitable for evaluation
Inclusion criteria for systemic sclerosis patients
* Systemic sclerosis Inclusion criteria for control
* Subjet that underwent or must undergo an upper and a lower jaw bone Cone Beam Computed Tomography examination (impacted teeth assessment, implant treatment planning)
Exclusion Criteria:
Common exclusion criteria
* Overt acute or chronic infection (HIV, viral hepatitis…) known at the time of the oral examination
* Progressive neoplasia or neoplasia diagnosed within 2 years prior to the study
* Ongoing antibiotic treatment or within 3 months before oral examination
* Individuals at risk of infective endocarditis
* Oral antiseptics within the week before oral examination (chlorhexidine mouthwashes…)
* Periodontal specialized treatments, root scaling/root planning or periodontal surgical treatment within the year before oral examination
* Ongoing medical treatment inducing a significant modification of the gingival state (anti-epileptic drugs…)
* Smoking (≥ 10 cigarettes per day)
* Pregnancy female subjects (positive urine pregnancy test)
* Lactating female subjects
* Impossibility to provide accurate informations (emergency situation, comprehension difficulties…)
Exclusion criteria for systemic sclerosis patients
* Patient currently involved in an other clinical trial (drug) or in an exclusion period following participation in another clinical trial
* 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 (diabetes…)
* Immunosuppressive therapy during the last month
* Corticosteroid ≥10 mg/day during the last month
* Hematopoietic stem cell transplant recipient
* Another cause of skin sclerosis (radiotherapy on the oro-facial region…)
Exclusion criteria for control
* Systemic chronic or evolutive illness at the time of the inclusion
* Progressive pathology involving the maxilla or the mandible at the time of the inclusion (tumor…)
* Ongoing treatment with corticsteroids or non-steroidal anti-inflammatory drugs
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02371005
Study Brief:
Protocol Section:
NCT02371005