Biomarkers for Differentiating Reversible and Irreversible Pulpitis (PULPBIOM)
Role of Inflammatory, Oxidative Stress, Neurogenic, and Immunological Biomarkers in Pulp Blood for the Differential Diagnosis of Reversible and Irreversible Pulpitis
This observational study aims to evaluate the role of inflammatory, oxidative stress, neurogenic, and immunological biomarkers obtained from pulpal blood in the differential diagnosis of normal pulp, reversible pulpitis, and irreversible pulpitis.
A total of 75 teeth from systemically healthy individuals aged 12-35 years will be included and classified into three groups: normal pulp, reversible pulpitis, and irreversible pulpitis, based on clinical examination, radiographic findings, and pulp sensibility tests. No additional treatment procedures will be performed for research purposes. All dental procedures will be carried out according to routine clinical protocols.
During routine treatment, after pulp exposure, approximately 50 μL of pulpal blood that would otherwise be discarded as medical waste will be collected using a micropipette. Samples will be stored and analyzed using Enzyme-Linked ImmunoSorbent Assay (ELISA) to determine the levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers. The results will be compared among the three groups to identify biomarkers that may improve the accuracy of pulpitis diagnosis and support clinical decision-making.
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Kütahya
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Kütahya、Kütahya、土耳其（türkiye）、43100
- Kütahya Health Sciences University Faculty of Dentistry
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Individuals aged 12 to 35 years
- Systemically healthy individuals
- Patients presenting for routine restorative treatment or root canal treatment
- Teeth classified into one of the following pulpal status groups: healthy pulp, reversible pulpitis, or irreversible pulpitis
- Confirmation of pulp vitality by pulp sensibility tests
- Ability to obtain pulp exposure and collect an adequate pulpal blood sample during treatment
Exclusion Criteria:
- No response to pulp sensibility tests
- Teeth that are not restorable
- Presence of a sinus tract
- Radiographic evidence of periapical pathology
- Presence of internal or external root resorption
- Teeth with open apices
- Presence of systemic disease
- Pregnancy
- History of non-steroidal anti-inflammatory drug (NSAID) or antibiotic use within the last week
- Requirement for prophylactic antibiotic use
- Teeth in which pulp exposure cannot be achieved after complete caries removal
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Normal Pulp
Teeth diagnosed with healthy pulp and scheduled for elective root canal treatment due to prosthetic indications.
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Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.
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Reversible Pulpitis
Teeth diagnosed with reversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests.
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Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.
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Irreversible Pulpitis
Teeth diagnosed with irreversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests.
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Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers in pulpal blood samples
大体时间：At the time of treatment (baseline)
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Comparison of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10), matrix metalloproteinase-9 (MMP-9), transforming growth factor-beta 1 (TGF-β1), presepsin, substance p, semaphoric 3A (SEMA3A), semaphoric 4D (SEMA4D), semaphoric 7A (SEMA7A), total antioxidant status (TAS), total oxidant status (TOS), malondialdehyde (MDA), glutathione (GSH), and superoxide dismutase (SOD) levels among healthy pulp, reversible pulpitis, and irreversible pulpitis groups.
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At the time of treatment (baseline)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic performance of pulpal blood biomarkers
大体时间：At the time of treatment (baseline)
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Evaluation of the ability of measured biomarkers to differentiate healthy pulp, reversible pulpitis, and irreversible pulpitis.
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At the time of treatment (baseline)
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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