Role of Inflammatory, Oxidative Stress, Neurogenic, and Immunological Biomarkers in Pulp Blood for the Differential Diagnosis of Reversible and Irreversible Pulpitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers in pulpal blood samples
研究概览
简要总结
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.
详细描述
Current diagnosis of pulpal status relies primarily on clinical symptoms, sensibility tests, and radiographic findings, which may not always accurately reflect the underlying histopathological condition of the pulp. This study aims to investigate inflammatory, neurogenic, immunological, and oxidative stress biomarkers obtained from pulpal blood samples collected during routine dental treatment. Biomarker levels will be compared among teeth with normal pulp, reversible pulpitis, and irreversible pulpitis. The findings may contribute to the development of objective diagnostic tools for more accurate differentiation of pulpal conditions and improved treatment decision-making.
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
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Normal Pulp
Teeth diagnosed with healthy pulp and scheduled for elective root canal treatment due to prosthetic indications.
干预措施: Pulpal Blood Biomarker Analysis (Diagnostic Test)
Reversible Pulpitis
Teeth diagnosed with reversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests.
干预措施: Pulpal Blood Biomarker Analysis (Diagnostic Test)
Irreversible Pulpitis
Teeth diagnosed with irreversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests.
干预措施: Pulpal Blood Biomarker Analysis (Diagnostic Test)
结局指标
主要结局
Levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers in pulpal blood samples
时间窗: At the time of treatment (baseline)
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.
次要结局
未报告次要终点
研究者
Safa
Assoc. Prof.
Kutahya Health Sciences University