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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT07141758
Eligibility Criteria:
Inclusion Criteria:
* Participants aged 18 years or older
* Clinically diagnosed with minor recurrent aphthous stomatitis (RAS) (defined as having a history of at least three RAS episodes within the past year)
* Systemically healthy (i.e., without any diagnosed systemic disease)
* No history of tobacco use
* Presence of at least one active aphthous ulcer at the time of saliva sample collection
* No known mental or physical disabilities
Exclusion Criteria:
* Use of any pharmacological treatment within the past 3 months
* Use of antiseptic mouthwash within the past 3 months
* Pregnant or lactating individuals, or those currently using oral contraceptives
* History of systemic diseases associated with oral ulcerations such as Crohn's disease, ulcerative colitis, celiac disease, or Behçet's disease
* History of chemotherapy or radiotherapy
* Current or prior use of immunomodulatory drugs, cytotoxic agents, or systemic corticosteroids
* Undergoing orthodontic treatment (to avoid misdiagnosis with traumatic ulcers)
* Use of removable dental prostheses (to avoid misdiagnosis with traumatic ulcers)
* Presence of periodontal disease (CPI score of 3 or 4)
* Caries risk not classified as very low (DMFT ≥ 5)
* Presence of pathological oral mucosal lesions such as lichen planus, pemphigus vulgaris, or mucous membrane pemphigoid
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07141758
Study Brief:
Protocol Section:
NCT07141758