Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07141758

Investigation of Salivary E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 Levels in Patients With Recurrent Aphthous Stomatitis

Led by Selin Yeşiltepe · Updated on 2025-08-26

102

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

S

Selin Yeşiltepe

Lead Sponsor

A

Aydın Adnan Menderes University Scientific Research Projects Unit

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the salivary levels of E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 (MMP-9) in adults with minor Recurrent Aphthous Stomatitis (RAS) compared to healthy individuals. The study aims to find out if these proteins differ significantly between people with minor RAS and those without, and whether they can serve as biomarkers related to the disease. The trial involves two groups: patients with clinically diagnosed minor RAS and healthy controls matched by age and gender. Participants will provide unstimulated saliva samples collected with a saliva swab and undergo clinical checks for periodontal health and tooth decay risk using the Community Periodontal Index (CPI) and DMFT index, respectively. Saliva samples will be processed and stored frozen until analyzed using ELISA kits to measure the concentrations of the three proteins and total protein levels. The study includes only participants with low caries risk and without significant periodontal disease. During the single study visit, participants will provide saliva samples and have their oral health evaluated through standardized clinical assessments. Researchers will analyze the saliva for protein levels and examine the relationships between these proteins and factors like age and sex. The main outcome is the measurement of salivary E-cadherin, Calprotectin, and MMP-9 levels. This observational study is designed to improve understanding of minor RAS by comparing these protein levels between affected patients and healthy controls.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 years or older
  • Clinically diagnosed with minor recurrent aphthous stomatitis (RAS) with at least three episodes in the past year
  • Systemically healthy without any diagnosed systemic disease
  • No history of tobacco use
  • Presence of at least one active aphthous ulcer at the time of saliva collection
  • No known mental or physical disabilities
Not Eligible

You will not qualify if you...

  • 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 using oral contraceptives
  • History of systemic diseases linked to oral ulcers 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
  • Use of removable dental prostheses
  • Presence of periodontal disease with CPI score of 3 or 4
  • Caries risk not very low (DMFT score 5 or higher)
  • Presence of pathological oral mucosal lesions such as lichen planus, pemphigus vulgaris, or mucous membrane pemphigoid

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single visit

Participants provide unstimulated saliva samples to measure concentrations of E-cadherin, Calprotectin, and MMP-9 using ELISA kits. Saliva collection is done non-invasively using a swab method following specific preparation instructions.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Aydın Adnan Menderes University

Aydin, Efeler, Turkey (Türkiye), 09010

Actively Recruiting

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Research Team

S

Sunay Hoşgör, dds

S

Selin Yeşiltepe, dds,msd

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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