Saliva levels of E-cadherin, calprotectin, and MMP-9 in people with recurrent mouth ulcers.
Official title: Investigation of Salivary E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 Levels in Patients With Recurrent Aphthous Stomatitis
Run by Aydin Adnan Menderes University · NCT07141758 · Data updated 2026-11-12
This will test whether three saliva proteins (E-cadherin, calprotectin, and MMP-9) are different in adults with minor recurrent aphthous stomatitis compared with healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 102 (estimated) |
| Sponsor | Aydin Adnan Menderes University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aydin, Efeler) |
| Status | Recruiting |
| Started | April 10, 2025 |
| Main results expected | April 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT07141758 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are systemically healthy, non-smokers, have a clinical diagnosis of minor RAS with at least three episodes in the past year and at least one active ulcer at the visit are ideal candidates.
✕Probably not a fit
People with systemic diseases linked to oral ulcers, recent pharmacologic treatments, current smokers, pregnant or lactating individuals, or those on immunomodulatory drugs are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a cross-sectional observational comparison of adults with minor recurrent aphthous stomatitis (RAS) and age-similar healthy controls. Unstimulated saliva will be collected with a swab, stored at -80°C, and analyzed by ELISA for E-cadherin, calprotectin, and MMP-9. Clinical exams will record periodontal status (CPI) and decay experience (DMFT) and patients must have at least one active aphthous lesion and a history of ≥3 episodes in the past year. The planned sample size is 102 participants to detect a moderate effect size with 80% power.
Why it matters
Potential benefit: If differences are confirmed, the findings could lead to a simple saliva-based marker set to help diagnose or monitor minor RAS and shed light on its causes.
How similar studies have gone: Prior small studies have measured salivary inflammatory markers in oral diseases, but using E-cadherin, calprotectin, and MMP-9 together as RAS biomarkers remains exploratory rather than established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Aydın Adnan Menderes University
Aydin, Efeler, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Selin Yeşiltepe, dds,msd — Aydin Adnan Menderes University
- Study coordinator: Sunay Hoşgör, dds
- Email: sunayhosgor@gmail.com
- Phone: +905313636708
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.