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

NCT07141758 | Recruiting

• 1 other identifier: 2025/02
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Aphthous Stomatitis; Aphthous Ulcer

Keywords

E-cadherin; Calprotectin; MMP-9; ELISA; Recurrent aphthous stomatitis; RAS; Saliva; Salivary Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (single visit)

Secondary Outcomes (1)

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

  Baseline (single visit)

Study Arms (2)

Minor Recurrent Aphthous Stomatitis Patients

Participants aged 18 years or older who have been clinically diagnosed with minor recurrent aphthous stomatitis (RAS) based on characteristic clinical features and medical history. The lesion must be round or oval, less than 5 mm in diameter, surrounded by an erythematous halo, and covered by a grayish-white pseudomembrane. Eligible patients must have experienced at least three episodes of RAS within the past year and present with at least one aphthous ulcer at the time of clinical examination and saliva collection.

Diagnostic Test: ELISA

Healthy Controls

Participants aged 18 years or older with no lifetime history of recurrent aphthous stomatitis. Control group participants will be selected to match the patient group in terms of age and gender distribution. At the time of saliva collection, no aphthous lesions or any active oral mucosal pathology should be present.

Diagnostic Test: ELISA

Interventions

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.

Healthy Controls; Minor Recurrent Aphthous Stomatitis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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

Sponsors & Collaborators

• Selin Yeşiltepe: lead
• Aydın Adnan Menderes University Scientific Research Projects Unit: collaborator
• Aydin Adnan Menderes University: collaborator

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Efeler, 09010, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Koray M, Atalay B, Akgul S, Oguz FS, Mumcu G, Saruhanoglu A. Relationship between salivary calprotectin levels and recurrent aphthous stomatitis: A preliminary study. Niger J Clin Pract. 2018 Mar;21(3):271-275. doi: 10.4103/njcp.njcp_23_17.

  PMID: 29519972 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated whole saliva samples will be collected using Salivette® saliva collection swabs (Sarstedt, Germany) from all participants. After centrifugation, the supernatant (clear fluid portion) will be separated and transferred into sterile Eppendorf tubes. These saliva supernatant samples will be stored at -80°C and retained for the analysis of proteins (E-cadherin, Calprotectin, and MMP-9) using ELISA. No DNA will be extracted or used from the samples.

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Selin Yeşiltepe, dds,msd

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunay Hoşgör, dds

CONTACT

+905313636708; sunayhosgor@gmail.com

Selin Yeşiltepe, dds,msd

CONTACT

+905058282990; dt_selin@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 26, 2025
• Study Start: April 10, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)