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

ConditionsRecurrent Aphthous Stomatitis Aphthous Ulcer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSelin Yeşiltepe

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study population will consist of a total of 102 participants, including 51 patients clinically diagnosed with minor recurrent aphthous stomatitis (RAS) and 51 healthy controls. All participants will be aged 18 years or older. Patients must have experienced at least three episodes of minor RAS within the past year and present with at least one active aphthous ulcer at the time of saliva collection. Only systemically healthy, non-smoking individuals without periodontal disease or oral mucosal pathology will be included. Control group participants will be matched by age and gender to the patient group and must have no lifetime history of RAS.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

ELISA
Diagnostic test
Unstimulated saliva samples will be non-invasively collected from participants in this study to measure the concentrations of E-cadherin, Calprotectin, and MMP-9. These protein concentrations will be quantified using commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kits.

Treatment groups

102 Participants

are divided into 2 treatment groups

Group A: Minor Recurrent Aphthous Stomatitis Patients1 intervention

Group B: Healthy Controls1 intervention

Trial outcomes

Primary outcomes

Salivary Concentrations of E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 (MMP-9) Using ELISA

The concentrations of E-cadherin, Calprotectin, and MMP-9 in unstimulated saliva samples will be measured using the Enzyme-Linked Immunosorbent Assay (ELISA) technique. Commercially available human ELISA kits will be used in accordance with the manufacturers' instructions. The analysis will be performed on the saliva supernatant collected from each participant, and results will be reported in ng/mL. Saliva samples will be collected from two groups: Minor Recurrent Aphthous Stomatitis (RAS) patients: Patients who present with at least one active aphthous ulcer at the time of saliva collection. Healthy controls: Participants without current aphthous lesions or any other active oral mucosal pathology at the time of saliva collection.

Time frame

Baseline (single visit)

Secondary outcomes

Total Salivary Protein Concentration Using Bicinchoninic Acid (BCA) Colorimetric Assay

Total protein concentration in unstimulated saliva samples will be measured using the Bicinchoninic Acid (BCA) Protein Colorimetric Assay Kit, following the manufacturer's protocol. The resulting values (expressed in mg/mL) will be used both for quantification and for normalizing the concentrations of investigated proteins (E-cadherin, Calprotectin, and MMP-9). This measure will help control for variability in salivary flow rate, sample volume, or protein content across participants. Minor Recurrent Aphthous Stomatitis (RAS) patients: Patients who present with at least one active aphthous ulcer at the time of saliva collection. Healthy controls: Participants without current aphthous lesions or any other active oral mucosal pathology at the time of saliva collection.

Time frame

Baseline (single visit)

Sponsors and contacts

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Selin Yeşiltepe

Lead sponsor

Aydin Adnan Menderes University

Sponsor institution

Aydın Adnan Menderes University Scientific Research Projects Unit

Collaborator