Oral Mucosa Clinical Trial
Official title:
Diagnostic Markers of Neuropathic Odontalgia : Proof of Concept Study
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.
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