Salivary E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 Levels in Recurrent Aphthous Stomatitis

Recruiting now

Conditions studied: Recurrent Aphthous Stomatitis, Aphthous Ulcer

In brief

The goal of this observational cross-sectional study is to determine the salivary levels of E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 (MMP-9) in patients with Recurrent Aphthous Stomatitis (RAS) and to compare them with those of healthy controls. The main questions it aims to answer are: Are the salivary levels of E-cadherin, Calprotectin, and MMP-9 significantly different in patients with minor RAS compared to healthy controls? Can these salivary proteins serve as biomarkers involved in the pathogenesis of minor RAS? Researchers will compare patients with minor RAS and healthy individuals to determine whether differences in salivary E-cadherin, Calprotectin, and MMP-9 levels are associated with the presence of disease. Participants will: Provide unstimulated saliva samples using a saliva swab Undergo clinical evaluation for periodontal status (Community Periodontal Index - CPI) and caries experience (DMFT index) Collected saliva samples will be stored at -80°C until analysis. The concentrations of the investigated proteins will be measured using ELISA kits, and total protein levels will be determined using a colorimetric protein assay. The relationships among the salivary concentrations of the investigated proteins, as well as their associations with demographic variables such as age and sex, will be analyzed.

Key facts

Study ID

NCT07141758

Run by

Selin Yeşiltepe

People needed

102

Starts

2025-04-10

Expected to finish

2026-06-30

Last updated by the study team

2025-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Aydın Adnan Menderes University — Aydin, Efeler, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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