Investigation of Salivary E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 Levels in Patients With Recurrent Aphthous Stomatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Salivary Concentrations of E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 (MMP-9) Using ELISA
研究概览
简要总结
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.
详细描述
Hypotheses H₀ (Null Hypothesis): There is no statistically significant difference in salivary levels of E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 (MMP-9) between patients with Recurrent Aphthous Stomatitis (RAS) and healthy controls.
H₁ (Alternative Hypothesis): There is a statistically significant difference in salivary levels of E-cadherin, Calprotectin, and MMP-9 between patients with RAS and healthy controls.
Sample Size Calculation Based on an effect size of 0.50, a power of 80%, and a type I error rate (α) of 5%, the required sample size for the study was calculated to be 102 participants using the "t tests - Means: Difference between two independent means (two groups)" module in G*Power (version 3.1).
Formation of Participant Groups Two study groups will be established: a patient group and a healthy control group. Patients clinically diagnosed with minor recurrent aphthous stomatitis (RAS) based on characteristic clinical appearance and medical history will be included in the patient group. For the diagnosis of minor RAS, a history of at least three episodes of RAS within the past year will be considered a required criterion. This lesion should be round or oval in shape, less than 5 mm in diameter, surrounded by an erythematous halo at the periphery, and covered by a grayish-white pseudomembrane. In order to obtain a salivary sample, at least one aphthous lesion must be present at the time of examination. Control group participants with a similar age and gender distribution and no lifetime history of RAS will be selected and included in the study.
In this study, the threshold value of DMFT < 5.0, defined by the World Health Organization (WHO) as a very low caries risk level in adults, will be used as an inclusion criterion for all participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Salivary Concentrations of E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 (MMP-9) Using ELISA
时间窗: Baseline (single visit)
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.
次要结局
- Total Salivary Protein Concentration Using Bicinchoninic Acid (BCA) Colorimetric Assay(Baseline (single visit))
研究者
Selin Yeşiltepe
Associate Professor
Aydin Adnan Menderes University