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).
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.
Study Type
OBSERVATIONAL
Enrollment
45
Immunostaining of oral mucosa/gingiva samples
Bretonneau Hospital
Paris, France
Patched-1 Western Blot concentration
Patched-1 will be measured in oral mucosa/gingiva samples using Western Blot
Time frame: Baseline
Patched-1 immunohistochemistry concentration
Patched-1 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Time frame: Baseline
Patched-1 ELISA concentration
Patched-1 will be measured in oral mucosa/gingiva samples using ELISA
Time frame: Baseline
Frizzled-7 Western Blot concentration
Frizzled-7 will be measured in oral mucosa/gingiva samples using Western Blot
Time frame: Baseline
Frizzled-7 immunohistochemistry concentration
Frizzled-7 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Time frame: Baseline
Frizzled-7 ELISA concentration
Frizzled-7 will be measured in oral mucosa/gingiva samples using ELISA
Time frame: Baseline
Claudin-5 Western Blot concentration
Claudin-5 will be measured in oral mucosa/gingiva samples using Western Blot
Time frame: Baseline
Claudin-5 immunohistochemistry concentration
Claudin-5 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Time frame: Baseline
Claudin-5 ELISA concentration
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Claudin-5 will be measured in oral mucosa/gingiva samples using ELISA
Time frame: Baseline