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临床试验/NCT04142918
NCT04142918Unknown不适用

Diagnostic Markers of Neuropathic Odontalgia : Proof of Concept Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年6月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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