Diagnostic Markers of Neuropathic Odontalgia : Proof of Concept Study
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Patched-1 Western Blot concentration
研究概览
简要总结
The DIAMOND study aims to investigate the presence and diagnostic relevance of potential biomarkers of the blood-nerve barrier disruption as surrogate markers of painful post-traumatic trigeminal neuropathic pain in patients presenting with neuropathic odontalgia. The first part of the study explores the proof-of-concept and technical feasibility of intra-epithelial nerve fiber immunostaining in gingival/oral mucosa biopsies and the potential presence of these biomarkers in healthy patients (baseline condition).
详细描述
Painful Post-Traumatic Trigeminal Neuropathy (PPTTN) defines a neuropathic painful condition affecting the orofacial region, following local nerve trauma, usually secondary to dental treatments (tooth avulsion, root canal treatments....). It often presents as odontalgia of atypical presentation, unresponsive to conventional treatments. The diagnostic is often complex (and often is a diagnosis of elimination), leading to unnecessary iatrogenic dental treatments and insufficient pain relief.
This study aims to explore potential new markers of PPTTN, based on a translational approach following previous preclinical work that showed the importance of the disruption of the blood-nerve barrier in generating post-traumatic neuropathic pain. Several markers of such disruption have been highlighted (such as Claudin-5, Patched-1 and Frizzled-7) that could be specifically downregulated in neuropathic pain conditions (as compared to inflammatory neuritis conditions). As such, these markers could be interesting biomarkers of neuropathic pain. This study aims to explore the presence (and absence) of such markers in healthy vs neuropathic patients respectively.
The first part of the study investigates the technical feasibility of intra-epithelial nerve fiber staining in oral mucosa/gingiva specimens collected in healthy patients (undergoing routine oral surgery procedures) and the immunoreactivity/presence of such biomarkers in those specimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Adult patients (over 18 years old) requiring an oral/dental surgical intervention that will generate gingival/mucosal tissue elimination (as part of the normal surgical procedure)
排除标准
- •Patient with a diagnosed odontalgia
- •Patient with Painful Post-Traumatic Trigeminal Neuropathy (PPTTN)
- •Patient with unexplained pains or a neuropathic pain regardless of its location
- •Patient under guardianship or trusteeship
- •Patient who refuses to give his/her non-opposition to participate to the study
结局指标
主要结局
Patched-1 Western Blot concentration
时间窗: Baseline
Patched-1 will be measured in oral mucosa/gingiva samples using Western Blot
Patched-1 immunohistochemistry concentration
时间窗: Baseline
Patched-1 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Patched-1 ELISA concentration
时间窗: Baseline
Patched-1 will be measured in oral mucosa/gingiva samples using ELISA
Frizzled-7 ELISA concentration
时间窗: Baseline
Frizzled-7 will be measured in oral mucosa/gingiva samples using ELISA
Claudin-5 immunohistochemistry concentration
时间窗: Baseline
Claudin-5 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Frizzled-7 Western Blot concentration
时间窗: Baseline
Frizzled-7 will be measured in oral mucosa/gingiva samples using Western Blot
Frizzled-7 immunohistochemistry concentration
时间窗: Baseline
Frizzled-7 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Claudin-5 Western Blot concentration
时间窗: Baseline
Claudin-5 will be measured in oral mucosa/gingiva samples using Western Blot
Claudin-5 ELISA concentration
时间窗: Baseline
Claudin-5 will be measured in oral mucosa/gingiva samples using ELISA
次要结局
未报告次要终点
